This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine
This study is being conducted to collect safety and immunogenicity data for the RVF vaccine, TSI-GSD 200, Lot 7, Run 2. Enrollment in this protocol is offered for personnel who enter areas where this virus is used in research or is endemic (an area where this disease process is found to occur frequently). Subjects who respond with a titer of \>1:40 may participate for study duration. Rift Valley Fever Vaccine, Inactivated, Dried (TSI GSD 200) will be administered in 1.0-mL doses SQ in the upper outer aspect of the arm.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
500
1.0 mL dose given SQ in upper arm
Special Immunization Program, Division of Medicine, USAMRIID
Fort Deterick, Maryland, United States
RECRUITINGNumber of Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine
Safety assess of local and systemic adverse events and their relationship to the study vaccine. AEs will be recorded for 28 days after each dose of the vaccine for the assessment population (all subjects who receive at least one vaccination under this protocol. Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.
Time frame: 0-28 days after each dose
Percentage of Subjects Who Developed Titers of ≥1:40 of Per-protocol Subjects
Percentage of per-protocol subjects (subjects who adhered to the protocol schedule for both vaccination and blood collects) who developed titers ≥1:40 as determined by PRNT80 (plaque reduction neutralization 80% titer) after vaccination at each scheduled time point for which blood samples are drawn and over the entire study period.
Time frame: 21-35 days after each vaccination and month 12
Frequency and Severity of Adverse Events
Frequency and severity of adverse events for the assessment population (all subjects who receive at least one vaccination under this protocol). Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.
Time frame: 0-28 days after each dose
Geometric Mean PRNT80 (plaque reduction neutralization 80% titer) of Per-protocol Subjects
Geometric mean PRNT80 (plaque reduction neutralization 80% titer) of per-protocol subjects at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
Time frame: 21-35 days after each vaccination and month 12
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