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

K L Kotloff; S S Wasserman; S O'Donnell; G A Losonsky; S J Cryz; M M Levine

doi:10.1128/iai.60.10.4430-4432.1992

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.

Authors

K L Kotloff¹, S S Wasserman, S O'Donnell, G A Losonsky, S J Cryz, M M Levine

Affiliation

¹ Department of Pediatrics, University of Maryland School of Medicine, Baltimore 21201.

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