Phase II safety and immunogenicity study of live chikungunya virus vaccine TSI-GSD-218

Am J Trop Med Hyg. 2000 Jun;62(6):681-5. doi: 10.4269/ajtmh.2000.62.681.

Abstract

We conducted a phase II, randomized, double-blind, placebo-controlled, safety and 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 and 14 were immunized with placebo (tissue culture fluid). Vaccinees were clinically evaluated intensively for one month, and 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 and severity of local and systemic reactions and abnormal laboratory tests after immunization were similar in CHIK vaccinees and placebo recipients. Fifty-seven (98%) of 58 evaluable CHIK vaccinees developed CHIK neutralizing antibody by day 28, and 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, and was highly immunogenic.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Alphavirus Infections / prevention & control*
  • Antibodies, Viral / blood
  • Chikungunya virus / immunology*
  • Double-Blind Method
  • Humans
  • Neutralization Tests
  • Vaccination
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / adverse effects*
  • Vaccines, Attenuated / immunology*
  • Viral Plaque Assay
  • Viral Vaccines / administration & dosage
  • Viral Vaccines / adverse effects*
  • Viral Vaccines / immunology*

Substances

  • Antibodies, Viral
  • Vaccines, Attenuated
  • Viral Vaccines