Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated (RVF)
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|ClinicalTrials.gov Identifier: NCT00869713|
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2009
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rift Valley Fever||Biological: Inactivated, Dried (TSI-GSD 200), RVF Vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-Term Open-Label Primary Vaccination and Booster Dose Study of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) in At-Risk Adults|
|Actual Study Start Date :||September 2009|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
primary vaccination with boost
Inactivated, Dried (TSI-GSD 200), RVF Vaccine
Biological: Inactivated, Dried (TSI-GSD 200), RVF Vaccine
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.
- PRNT80 ≥ 1:40 after primary series [ Time Frame: Between Days 28-42 ]% vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).
- PRNT80 ≥ 1:40 after 6-month mandatory booster dose [ Time Frame: 7 months ]% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).
- (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 [ Time Frame: up to 5 years ]% initial non-responders (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses.
- Median duration of PRNT80 ≥ 1:40 in initial responders [ Time Frame: up to 5 years ]Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose.
- Median duration of PRNT80 ≥ 1:40 in initial non-responders [ Time Frame: up to 5 years ]Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40.
- Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40 [ Time Frame: up to 1 year ]Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40.
- Subjects without symptoms [ Time Frame: 5 years ]
- Subjects with any category of local reaction (grade 1-4). [ Time Frame: 5 years ]
- Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4). [ Time Frame: 5 years ]
- Subjects with generalized allergic reactions [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869713
|United States, Maryland|
|U.S. Army Medical Research Institute of Infectious Diseases|
|Fort Deterick, Maryland, United States, 21702|
|Principal Investigator:||Ronald Reisler, MD||USAMRIID Medical Division|