Safety, immunogenicity, and transmissibility of single-dose live oral cholera vaccine strain CVD 103-HgR in 24- to 59-month-old Indonesian children.
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.
Simanjuntak
C H
CH
National Institute of Health Research and Development, US Naval Medical Research Unit No. 2, North Jakarta, Indonesia.
O'Hanley
P
P
Punjabi
N H
NH
Noriega
F
F
Pazzaglia
G
G
Dykstra
P
P
Kay
B
B
Suharyono
Budiarso
A
A
Rifai
A R
AR
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
D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D007074:Immunoglobulin G; D014613:Vaccines, Attenuated; D014614:Vaccines, Synthetic