Safety, Immunogenicity, and Transmissibility of Single-Dose Live Oral Cholera Vaccine Strain CVD l03-HgR in 24- to 59-Month-Old Indonesian Children

Myron M. Levine, Cyrus H. Simanjuntak, Peter O’Hanley, Narain H. Punjabi, Fernando Noriega, Gary Pazzaglia, Patricia Dykstra, Bradford Kay, Suharyono, Aswitha D.Budiarso, Atti R. Rifai, Steven S. Wasserman, Genevieve Losonsky, James Kaper, Stanley Cryz

Research output: Contribution to journalArticlepeer-review

60 Citations (Scopus)

Abstract

Recombinant A - B + Vibrio cholerae O1 strain CVD 103-HgR is a safe, highly immunogenic, single-dose live oral vaccine in adults in industrialized countries, Safety, excretion, immunogenicity, vaccine transmissibility, and environmental introduction ofCVD 103-HgR were investigated among 24- to 59-month-old children in Jakarta. In 81 households, 1 child was randomly allocated a single dose of vaccine (5 x 10 9 cfu) and another, placebo. Additionally, 139 unpaired children were randomly allocated vaccine or placebo. During 9 days of follow-up, diarrhea or vomiting did not occur more often among vaccinees than controls. Vaccine was minimally excreted and was isolated from no controls and from 1 (0.6%) of 177 unvaccinated family contacts. A 4-fold or higher rise in serum vibriocidal antibody was observed in 75% of vaccinees (10-fold rise in geometric mean titer over baseline). Of 135 paired placebo recipients or household contacts, 5 had vibriocidal seroconversions. Moore swabs placed in sewers and latrines near 97 households failed to detect vaccine. These observations pave the way for a large-scale field trial of efficacy.

Original languageEnglish
Pages (from-to)1169-1176
Number of pages8
JournalJournal of Infectious Diseases
Volume168
Issue number5
DOIs
Publication statusPublished - 1 Jan 1993

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