title: Safety, immunogenicity, and transmissibility of single-dose live oral cholera vaccine strain CVD 103-HgR in 24- to 59-month-old Indonesian children.
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 of CVD 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 vaccines 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 vaccines (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.
authors.affiliation: National Institute of Health Research and Development, US Naval Medical Research Unit No. 2, North Jakarta, Indonesia.
authors.forename: C H
authors.initials: CH
authors.lastname: Simanjuntak
authors.forename: P
authors.initials: P
authors.lastname: O'Hanley
authors.forename: N H
authors.initials: NH
authors.lastname: Punjabi
authors.forename: F
authors.initials: F
authors.lastname: Noriega
authors.forename: G
authors.initials: G
authors.lastname: Pazzaglia
authors.forename: P
authors.initials: P
authors.lastname: Dykstra
authors.forename: B
authors.initials: B
authors.lastname: Kay
authors.lastname: Suharyono
authors.forename: A
authors.initials: A
authors.lastname: Budiarso
authors.forename: A R
authors.initials: AR
authors.lastname: Rifai
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000917:Antibody Formation; D002675:Child, Preschool; D002771:Cholera / Q000517:prevention & control* / Q000635:transmission; D022121:Cholera Vaccines / Q000627:therapeutic use*; D005243:Feces / Q000382:microbiology; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007214:Indonesia; D012449:Safety; D014505:Urban Population; D014611:Vaccination / Q000009:adverse effects; D014613:Vaccines, Attenuated / Q000627:therapeutic use; D014614:Vaccines, Synthetic / Q000627:therapeutic use
chemical_list: D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D007074:Immunoglobulin G; D014613:Vaccines, Attenuated; D014614:Vaccines, Synthetic