Phase II safety and immunogenicity study of live chikungunya virus vaccine TSI-GSD-218
Autor(es): Edelman R, Tacket C O, Wasserman S S, Bodison S A, Perry J G, Mangiafico J A
Resumo: We conducted a phase II, r-omized, double-blind, placebo-controlled, safety - immunogenicity study of a serially passaged, plaque-purified live chikungunya (CHIK) vaccine in 73 healthy adult volunteers. Fifty-nine volunteers were immunized one time subcutaneously with the CHIK vaccine - 14 were immunized with placebo (tissue culture fluid). Vaccinees were clinically evaluated intensively for one month, - had repeated blood draws for serological assays (50% plaque-reduction neutralization test) for one year. Except for transient arthralgia in five CHIK vaccinees, the number - severity of local - systemic reactions - abnormal laboratory tests after immunization were similar in CHIK vaccinees - placebo recipients. Fifty-seven (98%) of 58 evaluable CHIK vaccinees developed CHIK neutralizing antibody by day 28, - 85% of vaccinees remained seropositive at one year after immunization. No placebo recipients seroconverted. This promising live vaccine was safe, produced well-tolerated side effects, - was highly immunogenic.
Imprenta: The American Journal of Tropical Medicine and Hygiene, v. 62, n. 6, p. 681-685, 2000
Descritores: Chikungunya virus - Pathogenesis ; Chikungunya virus - Proteins ; Chikungunya virus - Antibodies ; Chikungunya virus - Serology ; Chikungunya virus - Viral infections ; Chikungunya virus - Serological diagnosis ; Chikungunya virus - Serology ; Chikungunya Virus - Virus ; Chikungunya virus - Vaccine ; Chikungunya virus - Immunology ; Chikungunya virus - Public health
Data de publicação: 2000
