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

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/recombinan...

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Bibliographic Details
Published in:The Lancet (British edition) 1994-11, Vol.344 (8932), p.1273-1276
Main Authors: Sanchez, J.L, Vasquez, B, Begue, R.E, Meza, R, Castellares, G, Cabezas, C, Watts, D.M, Svennerholm, A-M, Sadoff, J.C, Taylor, D.N
Format: Article
Language:English
Subjects:
ABO Blood-Group System
Administration, Oral
Adolescent
Adult
Adults
Bacteria
Bacterial diseases
Biological and medical sciences
Blood group O
Blood groups
Cholera
Cholera - blood
Cholera - epidemiology
Cholera - microbiology
Cholera - prevention & control
Cholera Vaccines
Diarrhea
Double-Blind Method
Double-blind studies
E coli
Effectiveness
Efficacy
Epidemics
Follow-Up Studies
Human bacterial diseases
Humans
Immunization
Immunization Schedule
Incidence
Infectious diseases
Lymphocytes B
Male
Medical research
Medical sciences
Middle Aged
Military
Military Personnel
Peru
Peru - epidemiology
Population studies
Public health
Recruits
Serotyping
Tropical bacterial diseases
Tropical medicine
Vaccines
Vaccines, Inactivated
Vaccines, Synthetic
Vibrio cholerae - classification
Waterborne diseases
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Summary: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
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(94)90755-2