An investigational, @entity406 -inactivated @entity10787 ( @entity10787 ) 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 ( @entity43192 (80)>= 1:40) to the primary series was observed in 90% of subjects. Estimate of the @entity43192 (80) 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 ( @entity1 > @entity1 ); a trend was observed for age (<40 years). When response to the primary series was measured by @entity43192 (50) titer >= 1:40, nearly all subjects (99.1%) responded. In individuals not initially responding to the primary series ( @entity43192 (80)<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 ( @entity43192 (80)<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 @entity10787 vaccine, and may serve as a standard of comparison for immunogenicity and safety for future @entity10787 vaccines.

Immunogenicity and safety of an inactivated XXXX vaccine in a 19-year study.

@entity1 :: ('9606', 'Species') :: ['women', 'men'] @entity43192 :: ('149830', 'Gene') :: ['PRNT'] @entity10787 :: ('MESH:D012295', 'Disease') :: ['Rift Valley fever', 'RVF'] @entity406 :: ('MESH:D005557', 'Chemical') :: ['formalin']
@entity10787 :: (MESH:D012295,Disease) :: ['Rift Valley fever']
