Protective Efficacy of Oral Whole-Cell/Recombinant-B-Subunit Cholera Vaccine inPeruvian Military recruits

摘要

The cholera epidemic in South America has reinforced the need for safe andeffective 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 coil 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, Vibro cholerae 01 El Tor Ogawa was isolated from 17 subjects with diarrhea. 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