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| ID | Type | Description | Link |
|---|---|---|---|
| HSRRB # A-14057 | Other Identifier | USAMRMC | |
| WRAIR 1328 | Other Identifier | Walter Reed Army Institute of Research |
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| Name | Class |
|---|---|
| U.S. Army Office of the Surgeon General | FED |
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The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1: Group A, Dolphin 240 µg | Experimental | 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 (DolphinTM). |
|
| Stage 1: Group B, Dolphin 480 µg | Experimental | 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 (DolphinTM). |
|
| Stage 1: Group C, Dolphin 690 µg | Experimental | 690 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 (DolphinTM). |
|
| Stage 1: Group D, Pipette 240 µg | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 240 µg Shigella flexneri 2a Invaplex 50 vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group | 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). | 7 days after challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Post-challenge Loose Stool Samples Occurrences by Study Group | 7 days after challenge | |
| Post-challenge Loose Stool Sample Volumes by Study Group | 7 days after challenge | |
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Inclusion Criteria:
Exclusion Criteria:
General Health
Research specific
Additionally, subjects participating in stage 2 with any of the following will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Riddle, MD | Naval Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Immunization Research (CIR) John Hopkins Bayview Medical Center | Baltimore | Maryland | 21287 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Stage 2: Immunized / Challenge | Other | 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. |
|
| Stage 2: Controls | Placebo Comparator | A control was to be administered with the DolphinTM 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. |
|
|
| 480 µg Shigella flexneri 2a Invaplex 50 vaccine | Biological | 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 Shigella flexneri 2a Invaplex 50 vaccine | Biological | 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. |
|
| Shigella challenge strain | Other | 300 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T |
|
|
| Post-challenge Loose Stool Sample Durations by Study Group |
| 7 days after challenge |
| S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group | 56 days post-challenge |
| Number of Subjects Exhibiting an Immune Response to Invaplex 50 and/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). | 56 days post-vaccination in stage 1 |
| Department of Clinical Trials, WRAIR |
| Silver Spring |
| Maryland |
| 20910 |
| United States |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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 |
| FG005 | 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 |
| FG006 | 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 |
| FG007 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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 |
| BG005 | 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 |
| BG006 | 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 |
| BG007 | 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 |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group | 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). | 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. | Posted | Number | participants | 7 days after challenge |
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| Secondary | Post-challenge Loose Stool Samples Occurrences by Study Group | One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate. | Posted | Mean | Full Range | loose stools | 7 days after challenge |
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| Secondary | Post-challenge Loose Stool Sample Volumes by Study Group | One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate. | Posted | Mean | Full Range | mL | 7 days after challenge |
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| Secondary | Post-challenge Loose Stool Sample Durations by Study Group | One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate. | Posted | Mean | Full Range | hours | 7 days after challenge |
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| Secondary | S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group | Posted | Number | participants | 56 days post-challenge |
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| Secondary | Number of Subjects Exhibiting an Immune Response to Invaplex 50 and/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). | This analysis is limited to groups A-C only and subjects receiving at least 2 doses of S. flexneri 2a Invaplex 50 or LPS | Posted | Number | participants | 56 days post-vaccination in stage 1 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. | 0 | 12 | 0 | 12 | 10 | 12 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 11 | 12 |
| EG002 | 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. | 0 | 12 | 0 | 12 | 11 | 12 |
| EG003 | Stage 2: Immunized | 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 | 0 | 41 | 0 | 41 | 41 | 41 |
| EG004 | Stage 2: Controls | 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 | 0 | 28 | 1 | 28 | 28 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Reproductive system and breast disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Rhinorrhea | General disorders | Systematic Assessment |
| ||
| Nasal congestion | General disorders | Systematic Assessment |
| ||
| Nasal burning | General disorders | Systematic Assessment |
| ||
| Nasal itching | Gastrointestinal disorders | Systematic Assessment |
| ||
| Sore throat | General disorders | Systematic Assessment |
| ||
| Postnasal drip | General disorders | Systematic Assessment |
| ||
| Cough | General disorders | Systematic Assessment |
| ||
| Sinus pain | General disorders | Systematic Assessment |
| ||
| Sneezing | General disorders | Systematic Assessment |
| ||
| Itching eyes | Eye disorders | Systematic Assessment |
| ||
| Nose bleed | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Nasal mucosa hyperemia | General disorders | Systematic Assessment |
| ||
| Nasal discharge | General disorders | Systematic Assessment |
| ||
| Nasal edema | General disorders | Systematic Assessment |
| ||
| Pharyngeal erythema | General disorders | Systematic Assessment |
| ||
| Sinus tenderness | General disorders | Systematic Assessment |
| ||
| Lymphadenopathy | General disorders | Systematic Assessment |
| ||
| Conjunctival injection | Eye disorders | Systematic Assessment |
| ||
| Tearing | General disorders | Systematic Assessment |
| ||
| Epistaxis | General disorders | Systematic Assessment |
| ||
| Abnormal lung exam | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Abnormal cranial nerve finding | General disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Division of Regulated Activies and Compliance | US Army Medical Materiel Development Activity (USAMMDA) | 301-619-0317 | usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory-affairs@mail.mil |
| ID | Term |
|---|---|
| D004405 | Dysentery, Bacillary |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004403 | Dysentery |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Male |
|
| Caucasian |
|
| Other |
|
| Data Missing |
|
| Severe diarrhea |
|
| Fever |
|
| Blood in stools |
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
|
| OG002 | 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. |
|
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