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| ID | Type | Description | Link |
|---|---|---|---|
| FY08-07 | Other Identifier | IRB |
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This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults
The primary objectives are to assess safety of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and to assess immunogenicity of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200). The secondary objective is to assess incidence of RVF infection in vaccinated personnel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| primary vaccination with boost | Other | Inactivated, Dried (TSI-GSD 200), RVF Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated, Dried (TSI-GSD 200), RVF Vaccine | Biological | All subjects: 1.0-mL (SQ)doses on day 0, once between days 7 & 14, & once between days 28-42. Initial responders: A 6-month mandatory vaccine booster dose (1.0 mL, SQ) will be given if the PRNT80 is ≥1:40 after the primary series. Subsequent booster doses will be given for PRNT80 titer <1:40. Initial non-responders: Individual who has a PRNT80 titer <1:40 following the primary series may be administered a booster dose before 6 months. The individual will not receive the mandatory 6-month booster dose. Once an initial non-responder achieves PRNT80 ≥1:40, additional booster doses will be given for subsequent PRNT80 <1:40). All subjects: RVF booster dose will be administered within 90 days after a PRNT80 result of <1:40. |
| Measure | Description | Time Frame |
|---|---|---|
| PRNT80 ≥ 1:40 after primary series | % vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders). | Between Days 28-42 |
| PRNT80 ≥ 1:40 after 6-month mandatory booster dose | % vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only). | 7 months |
| (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 | % initial non-responders (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses. | up to 5 years |
| Median duration of PRNT80 ≥ 1:40 in initial responders | Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose. | up to 5 years |
| Median duration of PRNT80 ≥ 1:40 in initial non-responders | Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40. | up to 5 years |
| Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40 | Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40. | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects without symptoms | Number of subjects without symptoms | 5 years |
| Subjects with any category of local reaction (grade 1-4). | Number of subjects with any local reaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Reisler, MD | 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 | Jul 20, 2022 | |
| Reset | Aug 19, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 20, 2022 | Aug 19, 2022 |
| ID | Term |
|---|---|
| D012295 | Rift Valley Fever |
| D006482 | Hemorrhagic Fevers, Viral |
| D014777 | Virus Diseases |
| D009422 | Nervous System Diseases |
| D001102 | Arbovirus Infections |
| ID | Term |
|---|---|
| D006524 | Hepatitis, Viral, Animal |
| D006520 | Hepatitis, Animal |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D003890 | Desiccation |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055598 | Chemical Phenomena |
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Open-label, Phase 2, uncontrolled, vaccine study to assess the safety, immunogenicity of RVF (inactivated) vaccine (1.0 mL subcutaneous, SQ).
Three primary series doses; for responders to the vaccine (PRNT80 ≥ 1:40), 6 month mandatory vaccine booster dose;
Three primary series doses; for non-responders to the vaccine (PRNT80 < 1:40) may be boosted before 6 months.
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|
| 5 years |
| Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4). | Number of subjects with systemic reactions | 5 years |
| Subjects with generalized allergic reactions | Number of subjects with generalized allergic reactions | 5 years |
| D000079426 |
| Vector Borne Diseases |
| D002044 | Bunyaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000820 | Animal Diseases |