This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine
Study Objectives: The objectives of this two-part, primary immunization and booster dose, study are to continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is indicated; and, to provide potential protection for personnel at risk for occupational exposure to the RVF virus and collect data on incidence of occupational RVF infection (subclinical and clinical) in immunized personnel.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
278
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, United States
Safety: All Incidences of Erythema
Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study
Time frame: 12 months
Immunogenicity: Geometric Mean Titers After 3rd Vaccination
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study)
Time frame: 28 days after dose 3
Immunogenicity: Geometric Mean Titers Before 6-month Booster
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B
Time frame: Before 6-month booster
Immunogenicity: Geometric Mean Titers at 12 Months
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.
Time frame: at 12 months
Immunogenicity: Geometric Mean Titers After 6-month Booster
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.
Time frame: month 6 after dose 4
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