Accession Number : ADA541035


Title :   Immunogenicity and Safety of an Inactivated Rift Valley Fever Vaccine in a 19-Year Study


Descriptive Note : Journal article


Corporate Author : ARMY MEDICAL RESEARCH INST OF INFECTIOUS DISEASES FORT DETRICK MD


Personal Author(s) : Rusnak, Janice M ; Gibbs, Paul ; Boudreau, Ellen ; Clizbe, Denise P ; Pittman, Phillip


Full Text : https://apps.dtic.mil/dtic/tr/fulltext/u2/a541035.pdf


Report Date : 26 Feb 2011


Pagination or Media Count : 11


Abstract : An investigational, formalin-inactivated Rift Valley fever (RVF) vaccine, known as The Salk Institute-Government Services Division (TSI-GSD) 200 vaccine, was administered to 1860 at-risk subjects (5954 doses) between 1986 and 2004 as a three-dose primary series (days 0, 7, and 28) followed by booster doses as needed for declining titers. An initial positive serological response (PRNT80 or = 1:40) to the primary series was observed in 90% of subjects. Estimate of the PRNT80 response half-life in initial responders to the primary series by Kaplan-Meier plot was 315 days after the primary series dose 3. Differences in a serological response were observed at 2 weeks after dose 3 of the primary series between vaccine lots and for gender (women men); a trend was observed for age (40 years). When response to the primary series was measured by PRNT50 titer or = 1:40, nearly all subjects (99.1%) responded. In individuals not initially responding to the primary series (PRNT80 1:40), a response was observed in most subjects after receiving only one booster dose. Immune response (all subjects) to subsequent booster doses for a declining titer (PRNT80 1:40) was 98.4%. The vaccine was well-tolerated; vaccine-related adverse reactions were generally mild and self-limited. Differences in adverse events were observed with vaccine lot and sex. The data support the safety and immunogenicity of the inactivated RVF vaccine, and may serve as a standard of comparison for immunogenicity and safety for future RVF vaccines.


Descriptors :   *VACCINES , *RIFT VALLEY FEVER , SAFETY , TABLES(DATA) , STATISTICAL ANALYSIS , IMMUNOGENS , SEROLOGY , IMMUNIZATION , SEX , GRAPHS , REPRINTS , RESPONSE(BIOLOGY)


Subject Categories : Medicine and Medical Research
      Pharmacology


Distribution Statement : APPROVED FOR PUBLIC RELEASE