Trial Outcomes & Findings for Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection (NCT NCT00485134)
NCT ID: NCT00485134
Last Updated: 2017-09-11
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
113 participants
Primary outcome timeframe
7 days after challenge
Results posted on
2017-09-11
Participant Flow
Participant milestones
| Measure |
Stage 1: Group A, Dolphin 240 µg
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.
|
Stage 1: Group B, Dolphin 480 µg
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.
|
Stage 1: Group C, Dolphin 690 µg
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.
|
Stage 1: Group D, Pipette 240 µg
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.
|
Stage 2: Dolphin 690 ug (CTC WRAIR Site)
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)
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
|
Stage 2: Dolphin 690 ug (JHU CIR Site)
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 (JHU CIR 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
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
8
|
10
|
7
|
31
|
21
|
|
Overall Study
COMPLETED
|
11
|
10
|
9
|
7
|
7
|
3
|
28
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
1
|
3
|
4
|
3
|
1
|
Reasons for withdrawal
| Measure |
Stage 1: Group A, Dolphin 240 µg
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.
|
Stage 1: Group B, Dolphin 480 µg
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.
|
Stage 1: Group C, Dolphin 690 µg
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.
|
Stage 1: Group D, Pipette 240 µg
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.
|
Stage 2: Dolphin 690 ug (CTC WRAIR Site)
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)
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
|
Stage 2: Dolphin 690 ug (JHU CIR Site)
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 (JHU CIR 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
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Change in health status
|
0
|
1
|
2
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrew for adverse event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Positive drug test
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
|
Overall Study
Non-compliance
|
0
|
0
|
0
|
0
|
1
|
2
|
2
|
0
|
|
Overall Study
Unable to comply with study schedule
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection
Baseline characteristics by cohort
| Measure |
Stage 1: Group A, Dolphin 240 µg
n=12 Participants
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.
|
Stage 1: Group B, Dolphin 480 µg
n=12 Participants
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.
|
Stage 1: Group C, Dolphin 690 µg
n=12 Participants
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.
|
Stage 1: Group D, Pipette 240 µg
n=8 Participants
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.
|
Stage 2: Dolphin 690 ug (CTC WRAIR Site)
n=10 Participants
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)
n=7 Participants
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
|
Stage 2: Dolphin 690 ug (JHU CIR Site)
n=31 Participants
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 (JHU CIR Site)
n=21 Participants
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
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 7.1 • n=99 Participants
|
39.6 years
STANDARD_DEVIATION 4.4 • n=107 Participants
|
30.7 years
STANDARD_DEVIATION 7.3 • n=206 Participants
|
29.3 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
35.1 years
STANDARD_DEVIATION 10.2 • n=31 Participants
|
34.4 years
STANDARD_DEVIATION 10.4 • n=30 Participants
|
32.2 years
STANDARD_DEVIATION 8.3 • n=3 Participants
|
31.3 years
STANDARD_DEVIATION 8.2 • n=6 Participants
|
33.5 years
STANDARD_DEVIATION 7.7 • n=114 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
13 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
54 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
59 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
African-American
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
27 Participants
n=3 Participants
|
17 Participants
n=6 Participants
|
82 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
21 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Data Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 7 days after challengePopulation: 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.
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).
Outcome measures
| Measure |
Stage 2: Controls
n=12 Participants
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.
|
Stage 2: Immunized
n=10 Participants
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.
|
Stage 1: Group C, Dolphin 690 µg
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.
|
|---|---|---|---|
|
Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group
Mild diarrhea
|
1 participants
|
0 participants
|
—
|
|
Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group
Moderate diarrhea
|
4 participants
|
4 participants
|
—
|
|
Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group
Severe diarrhea
|
3 participants
|
3 participants
|
—
|
|
Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group
Fever
|
4 participants
|
5 participants
|
—
|
|
Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group
Blood in stools
|
4 participants
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: 7 days after challengePopulation: One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.
Outcome measures
| Measure |
Stage 2: Controls
n=12 Participants
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.
|
Stage 2: Immunized
n=10 Participants
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.
|
Stage 1: Group C, Dolphin 690 µg
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.
|
|---|---|---|---|
|
Post-challenge Loose Stool Samples Occurrences by Study Group
Number of loose stools
|
6.5 loose stools
Interval 4.0 to 8.0
|
8.0 loose stools
Interval 7.0 to 13.0
|
—
|
|
Post-challenge Loose Stool Samples Occurrences by Study Group
Maximum number in 24 hours period
|
4.0 loose stools
Interval 4.0 to 6.0
|
5.0 loose stools
Interval 4.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: 7 days after challengePopulation: One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.
Outcome measures
| Measure |
Stage 2: Controls
n=12 Participants
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.
|
Stage 2: Immunized
n=10 Participants
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.
|
Stage 1: Group C, Dolphin 690 µg
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.
|
|---|---|---|---|
|
Post-challenge Loose Stool Sample Volumes by Study Group
Total volume
|
540.5 mL
Interval 180.5 to 1251.0
|
706.0 mL
Interval 537.0 to 794.0
|
—
|
|
Post-challenge Loose Stool Sample Volumes by Study Group
Maximum volume loose stools in 24 hour period
|
422.0 mL
Interval 180.5 to 666.5
|
492.0 mL
Interval 410.0 to 555.0
|
—
|
SECONDARY outcome
Timeframe: 7 days after challengePopulation: One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.
Outcome measures
| Measure |
Stage 2: Controls
n=12 Participants
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.
|
Stage 2: Immunized
n=10 Participants
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.
|
Stage 1: Group C, Dolphin 690 µg
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.
|
|---|---|---|---|
|
Post-challenge Loose Stool Sample Durations by Study Group
Hours to first loose stool
|
59.7 hours
Interval 52.7 to 65.4
|
75.9 hours
Interval 46.0 to 90.1
|
—
|
|
Post-challenge Loose Stool Sample Durations by Study Group
Diarrhea duration
|
32.3 hours
Interval 18.3 to 53.0
|
47.4 hours
Interval 29.3 to 63.0
|
—
|
SECONDARY outcome
Timeframe: 56 days post-challengeOutcome measures
| Measure |
Stage 2: Controls
n=12 Participants
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.
|
Stage 2: Immunized
n=10 Participants
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.
|
Stage 1: Group C, Dolphin 690 µg
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.
|
|---|---|---|---|
|
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Nausea
|
4 participants
|
4 participants
|
—
|
|
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Vomiting
|
2 participants
|
2 participants
|
—
|
|
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Abdominal pain/cramps
|
7 participants
|
8 participants
|
—
|
|
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Malaise
|
5 participants
|
5 participants
|
—
|
|
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Bloating
|
3 participants
|
6 participants
|
—
|
|
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Flatulence
|
6 participants
|
5 participants
|
—
|
|
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Headache
|
7 participants
|
6 participants
|
—
|
|
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Lightheadedness
|
1 participants
|
0 participants
|
—
|
|
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Constipation
|
0 participants
|
0 participants
|
—
|
|
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Abdominal tenderness
|
2 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 56 days post-vaccination in stage 1Population: This analysis is limited to groups A-C only and subjects receiving at least 2 doses of S. flexneri 2a Invaplex 50 or LPS
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).
Outcome measures
| Measure |
Stage 2: Controls
n=11 Participants
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.
|
Stage 2: Immunized
n=10 Participants
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.
|
Stage 1: Group C, Dolphin 690 µg
n=12 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Exhibiting an Immune Response to Invaplex 50 and/or LPS
|
3 participants
|
2 participants
|
7 participants
|
Adverse Events
Stage 1: Group A, Dolphin 240 µg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Stage 1: Group B, Dolphin 480 µg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Stage 1: Group C, Dolphin 690 µg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Stage 2: Immunized
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Stage 2: Controls
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1: Group A, Dolphin 240 µg
n=12 participants at risk
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.
|
Stage 1: Group B, Dolphin 480 µg
n=12 participants at risk
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.
|
Stage 1: Group C, Dolphin 690 µg
n=12 participants at risk
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.
|
Stage 2: Immunized
n=41 participants at risk
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
|
Stage 2: Controls
n=28 participants at risk
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
|
|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Pregnancy
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
3.6%
1/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
Other adverse events
| Measure |
Stage 1: Group A, Dolphin 240 µg
n=12 participants at risk
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.
|
Stage 1: Group B, Dolphin 480 µg
n=12 participants at risk
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.
|
Stage 1: Group C, Dolphin 690 µg
n=12 participants at risk
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.
|
Stage 2: Immunized
n=41 participants at risk
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
|
Stage 2: Controls
n=28 participants at risk
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
|
|---|---|---|---|---|---|
|
General disorders
Malaise
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
14.6%
6/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
7.1%
2/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Headache
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
16.7%
2/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
19.5%
8/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
32.1%
9/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Rhinorrhea
|
33.3%
4/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
25.0%
3/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
33.3%
4/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
24.4%
10/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
32.1%
9/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Nasal congestion
|
58.3%
7/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
16.7%
2/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
25.0%
3/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
29.3%
12/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
35.7%
10/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Nasal burning
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
19.5%
8/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
7.1%
2/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
Gastrointestinal disorders
Nasal itching
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
33.3%
4/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
41.7%
5/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
12.2%
5/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Sore throat
|
16.7%
2/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
33.3%
4/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
22.0%
9/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
25.0%
7/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Postnasal drip
|
16.7%
2/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
16.7%
2/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
41.7%
5/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
19.5%
8/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
21.4%
6/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Cough
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
33.3%
4/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
9.8%
4/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
10.7%
3/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Sinus pain
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
12.2%
5/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
3.6%
1/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Sneezing
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
33.3%
4/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
41.7%
5/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
34.1%
14/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
14.3%
4/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
Eye disorders
Itching eyes
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
16.7%
2/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
12.2%
5/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
10.7%
3/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Nose bleed
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
4.9%
2/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Fever
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
9.8%
4/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
3.6%
1/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Nasal mucosa hyperemia
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
48.8%
20/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
42.9%
12/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Nasal discharge
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
36.6%
15/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
42.9%
12/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Nasal edema
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
24.4%
10/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
25.0%
7/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Pharyngeal erythema
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
16.7%
2/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
4.9%
2/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
10.7%
3/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Sinus tenderness
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Lymphadenopathy
|
16.7%
2/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
16.7%
2/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
8.3%
1/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
7.3%
3/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
3.6%
1/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
Eye disorders
Conjunctival injection
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
17.1%
7/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
28.6%
8/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Tearing
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Epistaxis
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
Respiratory, thoracic and mediastinal disorders
Abnormal lung exam
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
3.6%
1/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
|
General disorders
Abnormal cranial nerve finding
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/12 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/41 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
0.00%
0/28 • Subjects Participating in Stages 1 and 2 who Experienced Surveyed Signs and Symptoms Post-vaccination
Group D was not included in findings due to they were for lot bridging only and not for dose-finding study.
|
Additional Information
Division of Regulated Activies and Compliance
US Army Medical Materiel Development Activity (USAMMDA)
Phone: 301-619-0317
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place