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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
98
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.
U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, United States
PRNT80 ≥ 1:40 after primary series
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 1 year
Subjects without symptoms
Number of subjects without symptoms
Time frame: 5 years
Subjects with any category of local reaction (grade 1-4).
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Number of subjects with any local reaction
Time frame: 5 years
Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4).
Number of subjects with systemic reactions
Time frame: 5 years
Subjects with generalized allergic reactions
Number of subjects with generalized allergic reactions
Time frame: 5 years