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Trial record 6 of 37 for:    "Shigellosis"

Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection

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: NCT00485134
Recruitment Status : Completed
First Posted : June 12, 2007
Results First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
U.S. Army Office of the Surgeon General
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Shigellosis
Interventions Biological: 240 µg Shigella flexneri 2a Invaplex 50 vaccine
Biological: 480 µg Shigella flexneri 2a Invaplex 50 vaccine
Biological: 690 Shigella flexneri 2a Invaplex 50 vaccine
Other: Shigella challenge strain
Enrollment 113
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stage 1: Group A, Dolphin 240 µg Stage 1: Group B, Dolphin 480 µg Stage 1: Group C, Dolphin 690 µg Stage 1: Group D, Pipette 240 µg Stage 2: Dolphin 690 ug (CTC WRAIR Site) Stage 2: Placebo Group (CTC WRAIR Site) Stage 2: Dolphin 690 ug (JHU CIR Site) Stage 2: Placebo Group (JHU CIR Site)
Hide Arm/Group Description

240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of lipopolysaccharides (LPS). 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. These subjects received 200 μL the vaccine via electronic pipette. This group is for lot bridging only, not included in dose-finding study.

240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

Stage 2: Placebo group (CTC WRAIR site) A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

Period Title: Overall Study
Started 12 12 12 8 10 7 31 21
Completed 11 10 9 7 7 3 28 20
Not Completed 1 2 3 1 3 4 3 1
Reason Not Completed
Lost to Follow-up             1             0             0             0             0             0             0             0
Withdrawal by Subject             0             1             0             0             0             0             0             0
Change in health status             0             1             2             1             0             1             0             0
Withdrew for adverse event             0             0             1             0             0             0             0             0
Positive drug test             0             0             0             0             2             1             0             0
Non-compliance             0             0             0             0             1             2             2             0
Unable to comply with study schedule             0             0             0             0             0             0             0             1
Pregnancy             0             0             0             0             0             0             1             0
Arm/Group Title Stage 1: Group A, Dolphin 240 µg Stage 1: Group B, Dolphin 480 µg Stage 1: Group C, Dolphin 690 µg Stage 1: Group D, Pipette 240 µg Stage 2: Dolphin 690 ug (CTC WRAIR Site) Stage 2: Placebo Group (CTC WRAIR Site) Stage 2: Dolphin 690 ug (JHU CIR Site) Stage 2: Placebo Group (JHU CIR Site) Total
Hide Arm/Group Description

240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. These subjects received 200 μL the vaccine via electronic pipette. This group is for lot bridging only, not included in dose-finding study.

240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 8 10 7 31 21 113
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 12 participants 8 participants 10 participants 7 participants 31 participants 21 participants 113 participants
38.1  (7.1) 39.6  (4.4) 30.7  (7.3) 29.3  (7.1) 35.1  (10.2) 34.4  (10.4) 32.2  (8.3) 31.3  (8.2) 33.5  (7.7)
[1]
Measure Description: Age for stage 2 groups do not include data from individuals who were at Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) (10 immunized and 7 controls). Data is entered as presented in the Final Clinical Study Report.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 8 participants 10 participants 7 participants 31 participants 21 participants 113 participants
Female
5
  41.7%
5
  41.7%
7
  58.3%
3
  37.5%
4
  40.0%
2
  28.6%
13
  41.9%
15
  71.4%
54
  47.8%
Male
7
  58.3%
7
  58.3%
5
  41.7%
5
  62.5%
6
  60.0%
5
  71.4%
18
  58.1%
6
  28.6%
59
  52.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 8 participants 10 participants 7 participants 31 participants 21 participants 113 participants
African-American
7
  58.3%
8
  66.7%
9
  75.0%
2
  25.0%
6
  60.0%
6
  85.7%
27
  87.1%
17
  81.0%
82
  72.6%
Caucasian
5
  41.7%
3
  25.0%
1
   8.3%
3
  37.5%
1
  10.0%
1
  14.3%
3
   9.7%
4
  19.0%
21
  18.6%
Other
0
   0.0%
1
   8.3%
2
  16.7%
3
  37.5%
1
  10.0%
0
   0.0%
1
   3.2%
0
   0.0%
8
   7.1%
Data Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.8%
1.Primary Outcome
Title Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group
Hide Description Fecal samples were collected through day 77 or until discharge (all stools collected for weighing/grading; maximum of 3 stools/day for culture; rectal swab obtained if no stool provided).
Time Frame 7 days after challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The decision criteria to progress to challenge with the Shigella challenge strain were no limiting adverse events (AEs) and positive immune response. These individuals were challenged with 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.
Arm/Group Title Stage 2: Controls Stage 2: Immunized
Hide Arm/Group Description:

A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.

The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.

Overall Number of Participants Analyzed 12 10
Measure Type: Number
Unit of Measure: participants
Mild diarrhea 1 0
Moderate diarrhea 4 4
Severe diarrhea 3 3
Fever 4 5
Blood in stools 4 5
2.Secondary Outcome
Title Post-challenge Loose Stool Samples Occurrences by Study Group
Hide Description [Not Specified]
Time Frame 7 days after challenge
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.
Arm/Group Title Stage 2: Controls Stage 2: Immunized
Hide Arm/Group Description:

A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.

The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.

Overall Number of Participants Analyzed 12 10
Mean (Full Range)
Unit of Measure: loose stools
Number of loose stools
6.5
(4.0 to 8.0)
8.0
(7.0 to 13.0)
Maximum number in 24 hours period
4.0
(4.0 to 6.0)
5.0
(4.0 to 9.0)
3.Secondary Outcome
Title Post-challenge Loose Stool Sample Volumes by Study Group
Hide Description [Not Specified]
Time Frame 7 days after challenge
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.
Arm/Group Title Stage 2: Controls Stage 2: Immunized
Hide Arm/Group Description:

A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.

The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.

Overall Number of Participants Analyzed 12 10
Mean (Full Range)
Unit of Measure: mL
Total volume
540.5
(180.5 to 1251.0)
706.0
(537.0 to 794.0)
Maximum volume loose stools in 24 hour period
422.0
(180.5 to 666.5)
492.0
(410.0 to 555.0)
4.Secondary Outcome
Title Post-challenge Loose Stool Sample Durations by Study Group
Hide Description [Not Specified]
Time Frame 7 days after challenge
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.
Arm/Group Title Stage 2: Controls Stage 2: Immunized
Hide Arm/Group Description:

A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.

The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.

Overall Number of Participants Analyzed 12 10
Mean (Full Range)
Unit of Measure: hours
Hours to first loose stool
59.7
(52.7 to 65.4)
75.9
(46.0 to 90.1)
Diarrhea duration
32.3
(18.3 to 53.0)
47.4
(29.3 to 63.0)
5.Secondary Outcome
Title S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Hide Description [Not Specified]
Time Frame 56 days post-challenge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stage 2: Controls Stage 2: Immunized
Hide Arm/Group Description:

A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.

The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.

Overall Number of Participants Analyzed 12 10
Measure Type: Number
Unit of Measure: participants
Nausea 4 4
Vomiting 2 2
Abdominal pain/cramps 7 8
Malaise 5 5
Bloating 3 6
Flatulence 6 5
Headache 7 6
Lightheadedness 1 0
Constipation 0 0
Abdominal tenderness 2 1
6.Secondary Outcome
Title Number of Subjects Exhibiting an Immune Response to Invaplex 50 and/or LPS
Hide Description Immune responder is defined as someone with both a serologic and an ASC response to either Invaplex 50 or LPS. Immune response defined as Serology: ≥ 4-fold increase in baseline serum titer antibody cecreting cells (ASC): ≥ 10 ASC per 106 peripheral blood mononuclear cells(PBMC).
Time Frame 56 days post-vaccination in stage 1
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is limited to groups A-C only and subjects receiving at least 2 doses of S. flexneri 2a Invaplex 50 or LPS
Arm/Group Title Stage 1: Group A, Dolphin 240 µg Stage 1: Group B, Dolphin 480 µg Stage 1: Group C, Dolphin 690 µg
Hide Arm/Group Description:

240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

Overall Number of Participants Analyzed 11 10 12
Measure Type: Number
Unit of Measure: participants
3 2 7
Time Frame Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Adverse Event Reporting Description Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
 
Arm/Group Title Stage 1: Group A, Dolphin 240 µg Stage 1: Group B, Dolphin 480 µg Stage 1: Group C, Dolphin 690 µg Stage 2: Immunized Stage 2: Controls
Hide Arm/Group Description

240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).

690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.

The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.

Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

All-Cause Mortality
Stage 1: Group A, Dolphin 240 µg Stage 1: Group B, Dolphin 480 µg Stage 1: Group C, Dolphin 690 µg Stage 2: Immunized Stage 2: Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/41 (0.00%)   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Stage 1: Group A, Dolphin 240 µg Stage 1: Group B, Dolphin 480 µg Stage 1: Group C, Dolphin 690 µg Stage 2: Immunized Stage 2: Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/41 (0.00%)   1/28 (3.57%) 
Reproductive system and breast disorders           
Pregnancy   0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/41 (0.00%)  1/28 (3.57%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stage 1: Group A, Dolphin 240 µg Stage 1: Group B, Dolphin 480 µg Stage 1: Group C, Dolphin 690 µg Stage 2: Immunized Stage 2: Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/12 (83.33%)   11/12 (91.67%)   11/12 (91.67%)   41/41 (100.00%)   28/28 (100.00%) 
Eye disorders           
Itching eyes   1/12 (8.33%)  1/12 (8.33%)  2/12 (16.67%)  5/41 (12.20%)  3/28 (10.71%) 
Conjunctival injection   0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  7/41 (17.07%)  8/28 (28.57%) 
Gastrointestinal disorders           
Nasal itching   1/12 (8.33%)  4/12 (33.33%)  5/12 (41.67%)  5/41 (12.20%)  0/28 (0.00%) 
General disorders           
Malaise   1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%)  6/41 (14.63%)  2/28 (7.14%) 
Headache   1/12 (8.33%)  1/12 (8.33%)  2/12 (16.67%)  8/41 (19.51%)  9/28 (32.14%) 
Rhinorrhea   4/12 (33.33%)  3/12 (25.00%)  4/12 (33.33%)  10/41 (24.39%)  9/28 (32.14%) 
Nasal congestion   7/12 (58.33%)  2/12 (16.67%)  3/12 (25.00%)  12/41 (29.27%)  10/28 (35.71%) 
Nasal burning   1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  8/41 (19.51%)  2/28 (7.14%) 
Sore throat   2/12 (16.67%)  0/12 (0.00%)  4/12 (33.33%)  9/41 (21.95%)  7/28 (25.00%) 
Postnasal drip   2/12 (16.67%)  2/12 (16.67%)  5/12 (41.67%)  8/41 (19.51%)  6/28 (21.43%) 
Cough   1/12 (8.33%)  0/12 (0.00%)  4/12 (33.33%)  4/41 (9.76%)  3/28 (10.71%) 
Sinus pain   0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  5/41 (12.20%)  1/28 (3.57%) 
Sneezing   1/12 (8.33%)  4/12 (33.33%)  5/12 (41.67%)  14/41 (34.15%)  4/28 (14.29%) 
Nose bleed   0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  2/41 (4.88%)  0/28 (0.00%) 
Fever   1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%)  4/41 (9.76%)  1/28 (3.57%) 
Nasal mucosa hyperemia   1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  20/41 (48.78%)  12/28 (42.86%) 
Nasal discharge   1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  15/41 (36.59%)  12/28 (42.86%) 
Nasal edema   1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  10/41 (24.39%)  7/28 (25.00%) 
Pharyngeal erythema   0/12 (0.00%)  0/12 (0.00%)  2/12 (16.67%)  2/41 (4.88%)  3/28 (10.71%) 
Sinus tenderness   0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/41 (0.00%)  0/28 (0.00%) 
Lymphadenopathy   2/12 (16.67%)  2/12 (16.67%)  1/12 (8.33%)  3/41 (7.32%)  1/28 (3.57%) 
Tearing   0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/41 (0.00%)  0/28 (0.00%) 
Epistaxis   0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/41 (0.00%)  0/28 (0.00%) 
Abnormal cranial nerve finding   0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/41 (0.00%)  0/28 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Abnormal lung exam   0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/41 (0.00%)  1/28 (3.57%) 
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
Name/Title: Division of Regulated Activies and Compliance
Organization: US Army Medical Materiel Development Activity (USAMMDA)
Phone: 301-619-0317
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00485134     History of Changes
Other Study ID Numbers: NMRC.2006.0007
HSRRB # A-14057 ( Other Identifier: USAMRMC )
WRAIR 1328 ( Other Identifier: Walter Reed Army Institute of Research )
First Submitted: June 11, 2007
First Posted: June 12, 2007
Results First Submitted: October 24, 2016
Results First Posted: September 11, 2017
Last Update Posted: September 11, 2017