Efficacy trial of single-dose live oral cholera vaccine CVD 103-HgR in North Jakarta, Indonesia, a cholera-endemic area.
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.
Richie
E E
EE
US Naval Medical Research Unit No. 2, Jakarta, Indonesia.
Punjabi
N H
NH
Sidharta
Y Y
YY
Peetosutan
K K
KK
Sukandar
M M
MM
Wasserman
S S
SS
Lesmana
M M
MM
Wangsasaputra
F F
FF
Pandam
S S
SS
Levine
M M
MM
O'Hanley
P P
PP
Cryz
S J
SJ
Simanjuntak
C H
CH
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
D022121:Cholera Vaccines