title: Efficacy trial of single-dose live oral cholera vaccine CVD 103-HgR in North Jakarta, Indonesia, a cholera-endemic area.
abstract: A randomized, double-blind, placebo-controlled efficacy trial of one dose of CVD 103-HgR live oral cholera vaccine was performed in Indonesia from 1993 to 1997. 67,508 persons aged 2-41 years ingested vaccine or placebo and were followed for four years, detecting cholera cases using hospital-based surveillance. A nested reactogenicity study (538 vaccinees, 535 controls) revealed no vaccine-attributable side effects. A nested immunogenicity study (N=657) showed vibriocidal seroresponses in 64-70% of vaccinees vs 1-2% of controls. Cholera incidence was lower than expected. 103 cases of Vibrio cholerae O1 El Tor diarrhea were detected, 93 evaluable for vaccine efficacy (43 vaccine, 50 placebo; efficacy=14%). A suggestion of protection was observed among persons with blood group O [P=0.12]. Only seven cases occurred within six months of vaccination, precluding assessment of short-term efficacy. In Jakarta, single-dose CVD 103-HgR did not confer long-term protection. Short-term protection from a single-dose and long-term protection from two doses have yet to be studied.
authors.affiliation: US Naval Medical Research Unit No. 2, Jakarta, Indonesia.
authors.forename: E E
authors.initials: EE
authors.lastname: Richie
authors.forename: N H
authors.initials: NH
authors.lastname: Punjabi
authors.forename: Y Y
authors.initials: YY
authors.lastname: Sidharta
authors.forename: K K
authors.initials: KK
authors.lastname: Peetosutan
authors.forename: M M
authors.initials: MM
authors.lastname: Sukandar
authors.forename: S S
authors.initials: SS
authors.lastname: Wasserman
authors.forename: M M
authors.initials: MM
authors.lastname: Lesmana
authors.forename: F F
authors.initials: FF
authors.lastname: Wangsasaputra
authors.forename: S S
authors.initials: SS
authors.lastname: Pandam
authors.forename: M M
authors.initials: MM
authors.lastname: Levine
authors.forename: P P
authors.initials: PP
authors.lastname: O'Hanley
authors.forename: S J
authors.initials: SJ
authors.lastname: Cryz
authors.forename: C H
authors.initials: CH
authors.lastname: Simanjuntak
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D002771:Cholera / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control; D022121:Cholera Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004641:Emigration and Immigration; D005260:Female; D006801:Humans; D007214:Indonesia / Q000453:epidemiology; D008297:Male; D012449:Safety; D012959:Socioeconomic Factors
chemical_list: D022121:Cholera Vaccines