Safety and immunogenicity in North Americans of a single dose of live oral cholera vaccine CVD 103-HgR: results of a randomized, placebo-controlled, double-blind crossover trial

Infect Immun. 1992 Oct;60(10):4430-2. doi: 10.1128/iai.60.10.4430-4432.1992.

Abstract

We conducted a double-blind, placebo-controlled, randomized crossover study to evaluate the safety and immunogenicity of a single 5 x 10(8)-CFU dose of live oral recombinant cholera vaccine CVD 103-HgR in 94 North American adults. The vaccine was well tolerated without associated adverse reactions. Despite minimal fecal excretion of vaccine, 97% of subjects exhibited serum vibriocidal antibody and 72% had antitoxin responses.

Publication types

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

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Antibodies, Bacterial / analysis
  • Cholera Vaccines / adverse effects
  • Cholera Vaccines / immunology*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Safety
  • Vaccines, Synthetic / adverse effects
  • Vaccines, Synthetic / immunology*

Substances

  • Antibodies, Bacterial
  • Cholera Vaccines
  • Vaccines, Synthetic