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| ID | Type | Description | Link |
|---|---|---|---|
| USAMRIID FY09-02 | Other Identifier | IRB |
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This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.
Study Objectives:
Primary: To assess safety of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.
Secondary: To evaluate immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccinated | Experimental | Western Equine Encephalitis Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, administered in 0.5 mL doses subcutaneously in the upper outer aspect of the triceps in a 3-dose primary series (Days 0, 7, and 28) with a mandatory boost (Day 180) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Western Equine Encephalitis Vaccine | Biological | Subject will be vaccinated with 0.5 mL of reconstituted WEE vaccine, inactivated, TSI-GSD 210 (Lot 3-1-92) subcutaneously in the upper outer aspect of the deltoid region. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Reporting Adverse Events by Vaccination and Sex | 28 days following each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | The primary endpoint used to measure immunogeniciyt of the WEE vaccine, the 80% plaque-reduction neautralization titer (PRNT 80), will be evaluated for subjects in the per protocol population. The secondary endpoint will be GMT, with 95% CI, of the PRNT 80 for WEE-specific antibodies at each scheduled timepoint. | Baseline and multiple dates throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald B Reisler, MD | USAMRIID Medical Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Unit, Division of Medicine, USAMRIID | Fort Deterick | Maryland | 21702-5011 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33240257 | Derived | Keshtkar-Jahromi M, Reisler RB, Haller JM, Clizbe DP, Rivard RG, Cardile AP, Pierson BC, Norris S, Saunders D, Pittman PR. The Western Equine Encephalitis Lyophilized, Inactivated Vaccine: An Update on Safety and Immunogenicity. Front Immunol. 2020 Nov 9;11:555464. doi: 10.3389/fimmu.2020.555464. eCollection 2020. |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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