Protective efficacy of oral whole-cell/recombinant-B-subunit cholera vaccine in Peruvian military recruits

J. L. Sanchez, B. Vasquez, R. E. Begue, R. Meza, G. Castellares, C. Cabezas, D. M. Watts, A. M. Svennerholm, J. C. Sadoff, D. N. Taylor

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Summary. The cholera epidemic in South America has reinforced the need for safe and effective oral vaccines. In a randomised, double-blind, placebo-controlled efficacy trial among 1563 Peruvian military recruits we have investigated the protective efficacy of an oral inactivated whole-cell/recombinant-B-subunit (WC/rBS) cholera vaccine. Participants were given two oral doses of cholera vaccine or Escherichia coli K12 placebo, with an interval of 7-14 days. 1426 (91%) subjects received the two prescribed doses and were followed up for a mean of 18 weeks (median 21 weeks). After vaccination, Vibrio cholerae 01 El Tor Ogawa was isolated from 17 subjects with diarrhoea. 16 of the cholera cases occurred 2 weeks or longer after the second dose of vaccine (14 placebo recipients, 2 vaccinees). We also detected 14 symptomless infections (11 [7 placebo recipients, 4 vaccinees]) 2 weeks or longer after the second dose. The vaccine had significant protective efficacy against cholera (86% [95% Cl 37-97], p<0·01) but not against symptomless infection (42% [-96 to 85]). All cholera cases were in people of blood group O, who made up 76% of the study population (p<0·01). Two doses of WC/rBS vaccine, given 1 to 2 weeks apart, provide rapid, short-term protection against symptomatic cholera in adult South Americans, who are predominantly of blood group O. Long-term efficacy studies in Peruvian adults and children are under way.

Original languageEnglish (US)
Pages (from-to)1273-1276
Number of pages4
JournalThe Lancet
Issue number8932
StatePublished - Nov 5 1994

ASJC Scopus subject areas

  • Medicine(all)


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