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Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03049488
Recruitment Status : Completed
First Posted : February 10, 2017
Results First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Respiratory Syncytial Virus
Interventions Biological: VRC-RSVRGP084-00-VP
Other: Aluminum Hydroxide Suspension
Enrollment 95
Recruitment Details Healthy adults were recruited from the Washington, D.C., metropolitan area.
Pre-assignment Details  
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Hide Arm/Group Description

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

Period Title: Overall Study
Started 15 15 20 15 15 15
Received First Product Administration 15 15 20 15 15 15
Received Optional Second Dose 10 11 11 9 11 10
Completed 13 13 20 13 13 15
Not Completed 2 2 0 2 2 0
Reason Not Completed
Lost to Follow-up             1             1             0             0             0             0
Moved from Area             1             0             0             1             1             0
Physician Decision             0             1             0             0             0             0
Withdrawal by Subject             0             0             0             1             1             0
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum Total
Hide Arm/Group Description

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

Total of all reporting groups
Overall Number of Baseline Participants 15 15 20 15 15 15 95
Hide Baseline Analysis Population Description
Population includes all enrolled subjects.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 20 participants 15 participants 15 participants 15 participants 95 participants
18-20 years
0
   0.0%
2
  13.3%
1
   5.0%
1
   6.7%
0
   0.0%
0
   0.0%
4
   4.2%
21-30 years
4
  26.7%
4
  26.7%
9
  45.0%
6
  40.0%
8
  53.3%
11
  73.3%
42
  44.2%
31-40 years
9
  60.0%
5
  33.3%
6
  30.0%
6
  40.0%
4
  26.7%
3
  20.0%
33
  34.7%
41-50 years
2
  13.3%
4
  26.7%
4
  20.0%
2
  13.3%
3
  20.0%
1
   6.7%
16
  16.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 20 participants 15 participants 15 participants 15 participants 95 participants
Female
9
  60.0%
6
  40.0%
9
  45.0%
8
  53.3%
9
  60.0%
8
  53.3%
49
  51.6%
Male
6
  40.0%
9
  60.0%
11
  55.0%
7
  46.7%
6
  40.0%
7
  46.7%
46
  48.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 20 participants 15 participants 15 participants 15 participants 95 participants
Asian
4
  26.7%
1
   6.7%
4
  20.0%
0
   0.0%
3
  20.0%
3
  20.0%
15
  15.8%
Black or African American
1
   6.7%
3
  20.0%
1
   5.0%
4
  26.7%
0
   0.0%
0
   0.0%
9
   9.5%
White
10
  66.7%
11
  73.3%
13
  65.0%
9
  60.0%
12
  80.0%
10
  66.7%
65
  68.4%
Multiracial
0
   0.0%
0
   0.0%
2
  10.0%
2
  13.3%
0
   0.0%
2
  13.3%
6
   6.3%
Hispanic/Latino
0
   0.0%
1
   6.7%
2
  10.0%
0
   0.0%
4
  26.7%
1
   6.7%
8
   8.4%
Body Mass Index (BMI)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 20 participants 15 participants 15 participants 15 participants 95 participants
18.5-24.9 kg/m^2
5
  33.3%
6
  40.0%
8
  40.0%
5
  33.3%
7
  46.7%
8
  53.3%
39
  41.1%
25.0-29.9 kg/m^2
8
  53.3%
3
  20.0%
9
  45.0%
7
  46.7%
7
  46.7%
5
  33.3%
39
  41.1%
30.0 kg/m^2 or over
2
  13.3%
6
  40.0%
3
  15.0%
3
  20.0%
1
   6.7%
2
  13.3%
17
  17.9%
1.Primary Outcome
Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Hide Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame 7 days after the first product administration (Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

Overall Number of Participants Analyzed 15 15 20 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Pain/Tenderness None
6
  40.0%
5
  33.3%
11
  55.0%
8
  53.3%
7
  46.7%
6
  40.0%
Mild
9
  60.0%
10
  66.7%
9
  45.0%
7
  46.7%
8
  53.3%
9
  60.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Swelling None
15
 100.0%
15
 100.0%
20
 100.0%
15
 100.0%
15
 100.0%
14
  93.3%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Redness None
15
 100.0%
15
 100.0%
20
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Local Symptom None
6
  40.0%
5
  33.3%
11
  55.0%
8
  53.3%
7
  46.7%
6
  40.0%
Mild
9
  60.0%
10
  66.7%
9
  45.0%
7
  46.7%
8
  53.3%
9
  60.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Hide Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame 7 days after the second product administration (Day 91)
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=62).
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

Overall Number of Participants Analyzed 10 11 11 9 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Pain/Tenderness None
3
  30.0%
6
  54.5%
6
  54.5%
4
  44.4%
2
  18.2%
3
  30.0%
Mild
7
  70.0%
5
  45.5%
5
  45.5%
5
  55.6%
8
  72.7%
7
  70.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Swelling None
10
 100.0%
11
 100.0%
11
 100.0%
9
 100.0%
11
 100.0%
10
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Redness None
10
 100.0%
11
 100.0%
11
 100.0%
9
 100.0%
11
 100.0%
10
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Local Symptom None
3
  30.0%
6
  54.5%
6
  54.5%
4
  44.4%
2
  18.2%
3
  30.0%
Mild
7
  70.0%
5
  45.5%
5
  45.5%
5
  55.6%
8
  72.7%
7
  70.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Hide Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame 7 days after each product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum All DS-Cav1 Dose Groups
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Overall Number of Participants Analyzed 15 15 20 15 15 15 95
Measure Type: Count of Participants
Unit of Measure: Participants
Pain/Tenderness None
4
  26.7%
5
  33.3%
8
  40.0%
3
  20.0%
4
  26.7%
3
  20.0%
27
  28.4%
Mild
11
  73.3%
10
  66.7%
12
  60.0%
12
  80.0%
10
  66.7%
12
  80.0%
67
  70.5%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
1
   1.1%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Swelling None
15
 100.0%
15
 100.0%
20
 100.0%
15
 100.0%
15
 100.0%
14
  93.3%
94
  98.9%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
1
   1.1%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Redness None
15
 100.0%
15
 100.0%
20
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
95
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Local Symptom None
4
  26.7%
5
  33.3%
8
  40.0%
3
  20.0%
4
  26.7%
3
  20.0%
27
  28.4%
Mild
11
  73.3%
10
  66.7%
12
  60.0%
12
  80.0%
10
  66.7%
12
  80.0%
67
  70.5%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
1
   1.1%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Hide Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame 7 days after the first product administration (Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

Overall Number of Participants Analyzed 15 15 20 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Malaise None
13
  86.7%
13
  86.7%
17
  85.0%
12
  80.0%
11
  73.3%
11
  73.3%
Mild
2
  13.3%
2
  13.3%
3
  15.0%
3
  20.0%
4
  26.7%
4
  26.7%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Myalgia None
15
 100.0%
13
  86.7%
19
  95.0%
9
  60.0%
12
  80.0%
13
  86.7%
Mild
0
   0.0%
2
  13.3%
1
   5.0%
6
  40.0%
3
  20.0%
2
  13.3%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Headache None
13
  86.7%
11
  73.3%
18
  90.0%
10
  66.7%
13
  86.7%
10
  66.7%
Mild
2
  13.3%
4
  26.7%
2
  10.0%
5
  33.3%
2
  13.3%
5
  33.3%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chills None
14
  93.3%
15
 100.0%
20
 100.0%
14
  93.3%
13
  86.7%
13
  86.7%
Mild
1
   6.7%
0
   0.0%
0
   0.0%
1
   6.7%
2
  13.3%
2
  13.3%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nausea None
14
  93.3%
14
  93.3%
19
  95.0%
15
 100.0%
14
  93.3%
14
  93.3%
Mild
1
   6.7%
1
   6.7%
1
   5.0%
0
   0.0%
1
   6.7%
1
   6.7%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Temperature None
15
 100.0%
15
 100.0%
20
 100.0%
15
 100.0%
14
  93.3%
15
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Systemic Symptom None
12
  80.0%
11
  73.3%
15
  75.0%
9
  60.0%
10
  66.7%
9
  60.0%
Mild
3
  20.0%
4
  26.7%
5
  25.0%
6
  40.0%
5
  33.3%
6
  40.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Hide Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame 7 days after the second product administration (Day 91)
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=62).
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

Overall Number of Participants Analyzed 10 11 11 9 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Malaise None
9
  90.0%
9
  81.8%
11
 100.0%
8
  88.9%
8
  72.7%
9
  90.0%
Mild
0
   0.0%
2
  18.2%
0
   0.0%
1
  11.1%
3
  27.3%
1
  10.0%
Moderate
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Myalgia None
9
  90.0%
10
  90.9%
9
  81.8%
8
  88.9%
10
  90.9%
7
  70.0%
Mild
1
  10.0%
1
   9.1%
2
  18.2%
1
  11.1%
1
   9.1%
3
  30.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Headache None
8
  80.0%
10
  90.9%
10
  90.9%
8
  88.9%
8
  72.7%
9
  90.0%
Mild
2
  20.0%
1
   9.1%
1
   9.1%
1
  11.1%
2
  18.2%
1
  10.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chills None
10
 100.0%
11
 100.0%
11
 100.0%
9
 100.0%
11
 100.0%
9
  90.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nausea None
10
 100.0%
11
 100.0%
11
 100.0%
9
 100.0%
11
 100.0%
9
  90.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Temperature None
10
 100.0%
11
 100.0%
11
 100.0%
9
 100.0%
11
 100.0%
9
  90.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Systemic Symptom None
7
  70.0%
9
  81.8%
9
  81.8%
7
  77.8%
7
  63.6%
6
  60.0%
Mild
2
  20.0%
2
  18.2%
2
  18.2%
2
  22.2%
3
  27.3%
4
  40.0%
Moderate
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Hide Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame 7 days after each product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum All DS-Cav1 Dose Groups
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Overall Number of Participants Analyzed 15 15 20 15 15 15 95
Measure Type: Count of Participants
Unit of Measure: Participants
Malaise None
12
  80.0%
11
  73.3%
17
  85.0%
12
  80.0%
9
  60.0%
11
  73.3%
72
  75.8%
Mild
2
  13.3%
4
  26.7%
3
  15.0%
3
  20.0%
6
  40.0%
4
  26.7%
22
  23.2%
Moderate
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Myalgia None
14
  93.3%
12
  80.0%
17
  85.0%
9
  60.0%
12
  80.0%
12
  80.0%
76
  80.0%
Mild
1
   6.7%
3
  20.0%
3
  15.0%
6
  40.0%
3
  20.0%
3
  20.0%
19
  20.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Headache None
12
  80.0%
10
  66.7%
17
  85.0%
9
  60.0%
11
  73.3%
10
  66.7%
69
  72.6%
Mild
3
  20.0%
5
  33.3%
3
  15.0%
6
  40.0%
3
  20.0%
5
  33.3%
25
  26.3%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
1
   1.1%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chills None
14
  93.3%
15
 100.0%
20
 100.0%
14
  93.3%
13
  86.7%
13
  86.7%
89
  93.7%
Mild
1
   6.7%
0
   0.0%
0
   0.0%
1
   6.7%
2
  13.3%
2
  13.3%
6
   6.3%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nausea None
14
  93.3%
14
  93.3%
19
  95.0%
15
 100.0%
14
  93.3%
13
  86.7%
89
  93.7%
Mild
1
   6.7%
1
   6.7%
1
   5.0%
0
   0.0%
1
   6.7%
2
  13.3%
6
   6.3%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Temperature None
15
 100.0%
15
 100.0%
20
 100.0%
15
 100.0%
14
  93.3%
14
  93.3%
93
  97.9%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
1
   6.7%
2
   2.1%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Systemic Symptom None
10
  66.7%
10
  66.7%
13
  65.0%
8
  53.3%
8
  53.3%
7
  46.7%
56
  58.9%
Mild
4
  26.7%
5
  33.3%
7
  35.0%
7
  46.7%
6
  40.0%
8
  53.3%
37
  38.9%
Moderate
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
2
   2.1%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Number of Subjects With Abnormal Laboratory Measures of Safety
Hide Description Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, white blood cell (WBC) and red blood cell (RBC) counts, and neutrophil, lymphocyte, monocyte, eosinophil and basophil percents and counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) differential, platelet, creatinine and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 7, 28, 84, 91 and 112. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
Time Frame Day 0 through Day 308
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who had laboratory results available at any study visit post baseline.
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum All DS-Cav1 Dose Groups
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Overall Number of Participants Analyzed 15 15 20 15 15 15 95
Measure Type: Count of Participants
Unit of Measure: Participants
ALT
0
   0.0%
1
   6.7%
1
   5.0%
1
   6.7%
0
   0.0%
0
   0.0%
3
   3.2%
Creatinine
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
WBC Count
1
   6.7%
0
   0.0%
0
   0.0%
1
   6.7%
1
   6.7%
0
   0.0%
3
   3.2%
Hemoglobin
3
  20.0%
0
   0.0%
1
   5.0%
1
   6.7%
4
  26.7%
1
   6.7%
10
  10.5%
Neutrophil Count
0
   0.0%
2
  13.3%
1
   5.0%
0
   0.0%
2
  13.3%
1
   6.7%
6
   6.3%
Lymphocyte Count
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
1
   1.1%
Eosinophil Count
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
1
   1.1%
8.Primary Outcome
Title Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs)
Hide Description Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 28 days after each study product administration. At other time periods between study product administrations and when greater than 28 days after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.
Time Frame Day 0 through Day 28 after product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

Overall Number of Participants Analyzed 15 15 20 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Related to Study Product
3
  20.0%
3
  20.0%
2
  10.0%
0
   0.0%
4
  26.7%
3
  20.0%
Unrelated to Study Product
3
  20.0%
7
  46.7%
12
  60.0%
7
  46.7%
7
  46.7%
6
  40.0%
9.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description SAEs were reported from receipt of first study product administration through the last expected study visit at Day 308. The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.
Time Frame Day 0 through Day 308
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

Overall Number of Participants Analyzed 15 15 20 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Related to Study Product
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unrelated to Study Product
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Primary Outcome
Title Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration
Hide Description Respiratory Syncytial Virus (RSV) cases were recorded in the study database from receipt of the first study product administration through the last study visit.
Time Frame Day 0 through Day 308
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant (N=95).
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

Overall Number of Participants Analyzed 15 15 20 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Hide Description Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter.
Time Frame 4 weeks after the first product administration (Week 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant (N=95).
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

Overall Number of Participants Analyzed 15 15 20 15 15 15
Geometric Mean (Full Range)
Unit of Measure: titer
Week 0 (Baseline, Pre-Administration)
777
(192 to 3167)
689
(288 to 2141)
736
(216 to 4676)
653
(186 to 2476)
707
(230 to 5725)
669
(321 to 1840)
Week 4
4203
(1001 to 10910)
3486
(1385 to 18852)
5422
(2050 to 13104)
5513
(1715 to 17602)
7495
(2370 to 16870)
6083
(2301 to 13522)
12.Secondary Outcome
Title Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Hide Description Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter.
Time Frame 4 weeks after the second product administration (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant (N=62).
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Hide Arm/Group Description:

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

Overall Number of Participants Analyzed 10 11 11 9 11 10
Geometric Mean (Full Range)
Unit of Measure: titer
Week 0 (Baseline, Pre-Administration)
866
(192 to 3167)
734
(288 to 2141)
790
(498 to 1601)
578
(186 to 1526)
680
(267 to 1300)
839
(486 to 1840)
Week 16
3844
(1108 to 9545)
2536
(1566 to 10771)
4201
(1985 to 9673)
4033
(2235 to 7977)
5193
(2783 to 9251)
4440
(1909 to 10551)
Time Frame Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
Adverse Event Reporting Description Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
 
Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Hide Arm/Group Description

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*)

*To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.

Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.

All-Cause Mortality
Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/20 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Hide Serious Adverse Events
Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/20 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/15 (80.00%)   12/15 (80.00%)   20/20 (100.00%)   13/15 (86.67%)   14/15 (93.33%)   12/15 (80.00%) 
Blood and lymphatic system disorders             
Anaemia * 1  3/15 (20.00%)  0/15 (0.00%)  1/20 (5.00%)  1/15 (6.67%)  4/15 (26.67%)  1/15 (6.67%) 
Neutropenia * 1  0/15 (0.00%)  2/15 (13.33%)  1/20 (5.00%)  0/15 (0.00%)  2/15 (13.33%)  1/15 (6.67%) 
Eosinophilia * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
Leukocytosis * 1  1/15 (6.67%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Leukopenia * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/15 (6.67%)  1/15 (6.67%)  0/15 (0.00%) 
Lymphadenopathy * 1  0/15 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Lymphopenia * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
Cardiac disorders             
Bradycardia * 1  0/15 (0.00%)  1/15 (6.67%)  1/20 (5.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Tachycardia * 1  0/15 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Gastrointestinal disorders             
Abdominal pain * 1  0/15 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
Diarrhoea * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Gastritis * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Toothache * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  1/15 (6.67%) 
Nausea  1  1/15 (6.67%)  1/15 (6.67%)  1/20 (5.00%)  0/15 (0.00%)  1/15 (6.67%)  2/15 (13.33%) 
General disorders             
Administration site pain  1  11/15 (73.33%)  10/15 (66.67%)  12/20 (60.00%)  12/15 (80.00%)  11/15 (73.33%)  12/15 (80.00%) 
Injection site bruising * 1  0/15 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Administration site swelling  1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Chills  1  1/15 (6.67%)  0/15 (0.00%)  0/20 (0.00%)  1/15 (6.67%)  2/15 (13.33%)  2/15 (13.33%) 
Malaise  1  3/15 (20.00%)  4/15 (26.67%)  3/20 (15.00%)  3/15 (20.00%)  6/15 (40.00%)  4/15 (26.67%) 
Pyrexia  1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  1/15 (6.67%) 
Infections and infestations             
Upper Respiratory Tract Infection * 1  2/15 (13.33%)  4/15 (26.67%)  7/20 (35.00%)  2/15 (13.33%)  2/15 (13.33%)  3/15 (20.00%) 
Bronchitis * 1  0/15 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Sinusitis * 1  0/15 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Viral infection * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Gastroenteritis * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Injury, poisoning and procedural complications             
Arthropod bite * 1  0/15 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Burns first degree * 1  0/15 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Contusion * 1  0/15 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Muscle strain * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Investigations             
Alanine aminotransferase increased * 1  0/15 (0.00%)  1/15 (6.67%)  1/20 (5.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Blood creatinine increased * 1  0/15 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Hepatic enzyme increased * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders             
Muscle spasms * 1  1/15 (6.67%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  1/15 (6.67%) 
Muscle twitching * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Musculoskeletal chest pain * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
Musculoskeletal pain * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Osteoarthritis * 1  0/15 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Myalgia  1  1/15 (6.67%)  3/15 (20.00%)  3/20 (15.00%)  6/15 (40.00%)  3/15 (20.00%)  3/15 (20.00%) 
Nervous system disorders             
Dizziness * 1  1/15 (6.67%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  1/15 (6.67%) 
Headache  1  3/15 (20.00%)  5/15 (33.33%)  3/20 (15.00%)  6/15 (40.00%)  4/15 (26.67%)  5/15 (33.33%) 
Presyncope * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
Headache * 1  1/15 (6.67%)  0/15 (0.00%)  1/20 (5.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Psychiatric disorders             
Abnormal dreams * 1  1/15 (6.67%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Anxiety * 1  0/15 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Laryngeal pain * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Vascular disorders             
Hypertension * 1  0/15 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
Hypotension * 1  1/15 (6.67%)  0/15 (0.00%)  0/20 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
1
Term from vocabulary, MedDRA 23.0
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Martin Gaudinski, MD
Organization: Vaccine Research Center, NIAID, NIH
Phone: (301) 451-8715
EMail: martin.gaudinski@nih.gov
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Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT03049488    
Other Study ID Numbers: 170058
17-I-0058 ( Other Identifier: NIH NIAID IRB )
First Submitted: February 9, 2017
First Posted: February 10, 2017
Results First Submitted: September 29, 2020
Results First Posted: October 23, 2020
Last Update Posted: October 23, 2020