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| ID | Type | Description | Link |
|---|---|---|---|
| FY06-27 | Other Identifier | SIP |
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The study is designed to assess the safety and immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.
Study Objectives:
Primary:
To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series
Secondary:
To assess incidence of VEE infection in C-84 boosted personnel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine | Experimental | VEE C-84 - Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEE C-84 | Biological | Subjects will receive a 0.5 mL subcutaneous injection in the upper outer aspect of arm; maximum of four boosters in 1 year if titer <1:20. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events (ITT) | Frequency of the following adverse events will be evaluated for all intent-to-treat subjects: headache, myalgia, fever, fatigue, sore throat, erythema, tenderness, and warmth. | Day 28 after each booster dose |
| Immunogenicity: TC-83 with PRNT80 ≥ 1:20 | Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose. | Between Days 28 and 35 after each booster dose |
| Immunogenicity: TC-83 with PRNT80 ≥ 1:20 | Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose. | 12-15 months after booster dose |
| Immunogenicity: TC-83 with PRNT80 < 1:20 | Number of initial responders to TC-83 who are non-responders (PRNT80 < 1:20) to C-84 booster dose. | Between Days 28 and 35 after each booster dose |
| Immunogenicity: TC-83 with PRNT80 < 1:20 | Number of initial responders to TC-83 who are non-responders (PRNT80 < 1:20) to C-84 booster dose. | 12-15 months after vaccination |
| Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses | After three booster doses | |
| Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose | 12- 15 months after first booster dose | |
| Immunogenicity: PRNT80 ≥ 1:20 after 1 dose |
| Measure | Description | Time Frame |
|---|---|---|
| VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20. | The number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20. | Length of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Cardile, DO | USAMRIID Medical Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.S. Army Medical Research Institute of Infectious Diseases | Fort Deterick | Maryland | 21702 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 8, 2022 | |
| Reset | Sep 6, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 8, 2022 | Sep 6, 2022 |
| ID | Term |
|---|---|
| D004685 | Encephalomyelitis, Venezuelan Equine |
| D004660 | Encephalitis |
| D014777 | Virus Diseases |
| D009422 | Nervous System Diseases |
| D018354 | Alphavirus Infections |
| ID | Term |
|---|---|
| D004683 | Encephalomyelitis, Equine |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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Number of rollovers from past C-84 booster study with PRNT80 ≥ 1:20 after 1 dose. |
| After 1 dose |
| Immunogenicity: PRNT80 ≥ 1:20 12-15 months post dose for new C-84 Protocol. | 12-15 months post dose for new C-84 Protocol |
| D007239 | Infections |
| D004679 | Encephalomyelitis |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D004671 | Encephalitis, Arbovirus |
| D000096724 | Mosquito-Borne Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |