Richie E E, Punjabi N H, Sidharta Y Y, Peetosutan K K, Sukandar M M, Wasserman S S, Lesmana M M, Wangsasaputra F F, Pandam S S, Levine M M, O'Hanley P P, Cryz S J, Simanjuntak C H
US Naval Medical Research Unit No. 2, Jakarta, Indonesia.
Vaccine. 2000 May 8;18(22):2399-410. doi: 10.1016/s0264-410x(00)00006-2.
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.
1993年至1997年在印度尼西亚进行了一项关于一剂CVD 103-HgR口服霍乱活疫苗的随机、双盲、安慰剂对照疗效试验。67508名年龄在2至41岁的人摄入了疫苗或安慰剂，并随访了四年，通过基于医院的监测来检测霍乱病例。一项嵌套的反应原性研究（538名疫苗接种者，535名对照）显示没有疫苗引起的副作用。一项嵌套的免疫原性研究（N = 657）表明，64%至70%的疫苗接种者出现杀弧菌血清反应，而对照组为1%至2%。霍乱发病率低于预期。检测到103例霍乱弧菌O1 El Tor腹泻病例，93例可评估疫苗效力（43例疫苗组，50例安慰剂组；效力 = 14%）。在O血型人群中观察到了保护作用的迹象[P = 0.12]。仅7例病例发生在接种疫苗后的六个月内，因此无法评估短期效力。在雅加达，单剂量CVD 103-HgR未提供长期保护。单剂量的短期保护和两剂量的长期保护尚未进行研究。
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