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Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX

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ClinicalTrials.gov Identifier: NCT03232567
Recruitment Status : Completed
First Posted : July 28, 2017
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Altimmune, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: NasoVAX
Enrollment 60
Recruitment Details Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects were screened within 28 days of randomization.
Pre-assignment Details 60 subjects who met all inclusion and no exclusion criteria and provided written informed consent were enrolled into 3 sequential cohorts of 20 subjects each defined by the vaccine dose (1×10^9, 1×10^10,1×10^11 vp). Within each cohort and its sentinel group, subjects were randomized in a 3:1 ratio to receive 1 intranasal dose of NasoVAX or placebo
Arm/Group Title NasoVAX Low Dose NasoVAX Medium Dose NasoVAX High Dose Placebo
Hide Arm/Group Description NasoVAX administered by intranasal spray at a single dose of 1×10^9 viral particles (vp) NasoVAX administered by intranasal spray at a single dose of 1×10^10 viral particles (vp) NasoVAX administered by intranasal spray at a single dose of 1×10^11 viral particles (vp) Normal saline administered by intranasal spray at a single dose
Period Title: Overall Study
Started 15 15 15 15
Completed 15 14 15 15
Not Completed 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0
Arm/Group Title NasoVAX Low Dose NasoVAX Medium Dose NasoVAX High Dose Placebo Total
Hide Arm/Group Description NasoVAX administered by intranasal spray at a single dose of 1×10^9viral particles (vp) NasoVAX administered by intranasal spray at a single dose of 1×10^10 viral particles (vp) NasoVAX administered by intranasal spray at a single dose of 1×10^11 viral particles (vp) Normal saline administered by intranasal spray at a single dose Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 15 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
30.1
(19 to 47)
31.6
(18 to 46)
32.6
(21 to 48)
29.3
(20 to 45)
30.9
(18 to 48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
Female
11
  73.3%
10
  66.7%
6
  40.0%
6
  40.0%
33
  55.0%
Male
4
  26.7%
5
  33.3%
9
  60.0%
9
  60.0%
27
  45.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
Hispanic or Latino
3
  20.0%
4
  26.7%
2
  13.3%
0
   0.0%
9
  15.0%
Not Hispanic or Latino
12
  80.0%
11
  73.3%
13
  86.7%
15
 100.0%
51
  85.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   6.7%
2
  13.3%
2
  13.3%
0
   0.0%
5
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  33.3%
4
  26.7%
5
  33.3%
6
  40.0%
20
  33.3%
White
7
  46.7%
7
  46.7%
7
  46.7%
9
  60.0%
30
  50.0%
More than one race
1
   6.7%
2
  13.3%
1
   6.7%
0
   0.0%
4
   6.7%
Unknown or Not Reported
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
1.Primary Outcome
Title Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability]
Hide Description Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Time Frame Day 1 to Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
All ALT-103-201 and ALT-FLZ-401 subjects who provide informed consent, are randomized, and receive at least 1 vaccination. The Safety Population will be used for all safety analyses and will be analyzed according to the treatment received.
Arm/Group Title NasoVAX Low Dose NasoVAX Medium Dose NasoVAX High Dose Placebo
Hide Arm/Group Description:

NasoVAX administered by intranasal spray at a single dose of 1×10^9 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

NasoVAX administered by intranasal spray at a single dose of 1×10^10 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

NasoVAX administered by intranasal spray at a single dose of 1×10^11 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

Normal saline administered by intranasal spray at a single dose
Overall Number of Participants Analyzed 15 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
10
  66.7%
10
  66.7%
10
  66.7%
15
 100.0%
Serious TEAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
IP Related TEAE
2
  13.3%
5
  33.3%
3
  20.0%
3
  20.0%
IP Related SAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or 4 TEAE
0
   0.0%
2
  13.3%
1
   6.7%
0
   0.0%
TEAE Leading to Withdrawal
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Treatment-Emergent Reactogenicity Events in Participants [Safety and Tolerability]
Hide Description Reactogenicity: counts and percentages of subjects with 'yes' to any reactogenicity event (nasal irritation, sneezing, nasal congestion, sore throat, change in smell, change in taste, change in vision, eye pain, headache, fatigue, muscle ache, nausea, vomiting, diarrhea, chills, fever)
Time Frame 14-days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All ALT-103-201 and ALT-FLZ-401 subjects who provide informed consent, are randomized, and receive at least 1 vaccination. The Safety Population will be used for all safety analyses and will be analyzed according to the treatment received.
Arm/Group Title NasoVAX Low Dose NasoVAX Medium Dose NasoVAX High Dose Placebo
Hide Arm/Group Description:

NasoVAX administered by intranasal spray at a single dose of 1×10^9 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

NasoVAX administered by intranasal spray at a single dose of 1×10^10 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

NasoVAX administered by intranasal spray at a single dose of 1×10^11 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

Normal saline administered by intranasal spray at a single dose
Overall Number of Participants Analyzed 15 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Any local event
9
  60.0%
9
  60.0%
6
  40.0%
6
  40.0%
Any systemic event
9
  60.0%
11
  73.3%
5
  33.3%
6
  40.0%
3.Secondary Outcome
Title HAI Immune Response
Hide Description Antibody level measured by hemagglutination inhibition (HAI) in serum
Time Frame Day 1 to Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the Safety Population that received the assigned dose of the test article, have HAI assay results on Days 1 and 29 and had no major protocol deviations affecting the primary immunogenicity outcomes prior to database lock. Per Protocol primary population for immunogenicity analyses was analyzed as randomized.
Arm/Group Title NasoVAX Low Dose NasoVAX Medium Dose NasoVAX High Dose Placebo
Hide Arm/Group Description:

NasoVAX administered by intranasal spray at a single dose of 1×10^9 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

NasoVAX administered by intranasal spray at a single dose of 1×10^10 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

NasoVAX administered by intranasal spray at a single dose of 1×10^11 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

Normal saline administered by intranasal spray at a single dose
Overall Number of Participants Analyzed 15 15 15 15
Geometric Mean (95% Confidence Interval)
Unit of Measure: GMT
83.8
(42.1 to 166.7)
160
(94.8 to 270)
152.8
(93.5 to 249.7)
27.6
(13.5 to 56.8)
4.Secondary Outcome
Title Microneutralization Immune Response
Hide Description Antibody level measured by microneutralization in serum
Time Frame Day 1 to Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the Safety Population that received the assigned dose of the test article, have HAI assay results on Days 1 and 29 and had no major protocol deviations affecting the primary immunogenicity outcomes prior to database lock. Per Protocol primary population for immunogenicity analyses was analyzed as randomized.
Arm/Group Title NasoVAX Low Dose NasoVAX Medium Dose NasoVAX High Dose Placebo
Hide Arm/Group Description:

NasoVAX administered by intranasal spray at a single dose of 1×10^9 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

NasoVAX administered by intranasal spray at a single dose of 1×10^10 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

NasoVAX administered by intranasal spray at a single dose of 1×10^11 viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

Normal saline administered by intranasal spray at a single dose
Overall Number of Participants Analyzed 15 15 15 15
Geometric Mean (95% Confidence Interval)
Unit of Measure: GMT
83.8
(42.1 to 166.7)
160.
(94.8 to 270)
152.8
(93.5 to 249.7)
27.6
(13.5 to 56.8)
Time Frame AEs Day 1 to day 29 Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Adverse Event Reporting Description Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
 
Arm/Group Title NasoVAX Low Dose NasoVAX Medium Dose NasoVAX High Dose Placebo
Hide Arm/Group Description

NasoVAX administered by intranasal spray at a single dose of 1×10(9th) viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

NasoVAX administered by intranasal spray at a single dose of 1×10(10th) viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo

NasoVAX: Single ascending dose study

Normal saline administered
All-Cause Mortality
NasoVAX Low Dose NasoVAX Medium Dose NasoVAX High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Hide Serious Adverse Events
NasoVAX Low Dose NasoVAX Medium Dose NasoVAX High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (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 0%
NasoVAX Low Dose NasoVAX Medium Dose NasoVAX High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/15 (66.67%)   10/15 (66.67%)   10/15 (66.67%)   15/15 (100.00%) 
Product Issues         
Any treatment emergent adverse event   10/15 (66.67%)  10/15 (66.67%)  10/15 (66.67%)  15/15 (100.00%) 
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: Stephanie Holland, Clinical Project Manager
Organization: Altimmune
Phone: 240-654-1450 ext 40
EMail: sholland@altimmune.com
Layout table for additonal information
Responsible Party: Altimmune, Inc.
ClinicalTrials.gov Identifier: NCT03232567    
Other Study ID Numbers: ALT103-201
First Submitted: July 24, 2017
First Posted: July 28, 2017
Results First Submitted: February 26, 2019
Results First Posted: April 11, 2019
Last Update Posted: April 11, 2019