Two-year study of the protective efficacy of the oral whole cell plus recombinant B subunit cholera vaccine in Peru

David N. Taylor, Vicky Cárdenas, José L. Sanchez, Rodolfo E. Bégué, Robert Gilman, Christian Bautista, Juan Perez, Romulo Puga, Alvaro Gaillour, Rina Meza, Peter Echeverria, Jerald Sadoff

Research output: Contribution to journalArticlepeer-review

Abstract

The protective efficacy of an oral inactivated whole cell Vibrio cholerae plus recombinant B subunit cholera vaccine was determined against El Tor cholera among Peruvian children and adults (2-65 years old) in a randomized, double-blind manner. Study subjects received 2 doses of vaccine or placebo 2 weeks apart, followed by a booster dose 10 months later. Surveillance for cholera was performed actively, with 2 visits per week to each household, and passively, at a local hospital. Stool samples were collected during diarrhea episodes and were cultured for V. cholerae. A total of 17,799 persons received 2 doses of vaccine or placebo, and 14,997 of these persons received the booster dose. After 2 doses (first surveillance period), V. cholerae biotype O1 was isolated from 17 vaccinees and 16 placebo recipients, demonstrating vaccine efficacy (VE) of -4%. After 3 doses (second surveillance period), V. cholerae O1 was isolated from 13 vaccinees and 32 placebo recipients, demonstrating VE of 61% (95% confidence interval [CI], 28%-79%). In the second surveillance period, the VE for illness requiring hospitalization was 82% (95% CI, 27%-96%). VE was also higher for persons >15 years old (VE, 72%; 95% CI, 28%-89%).

Original languageEnglish (US)
Pages (from-to)1667-1673
Number of pages7
JournalJournal of Infectious Diseases
Volume181
Issue number5
DOIs
StatePublished - 2000

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Fingerprint Dive into the research topics of 'Two-year study of the protective efficacy of the oral whole cell plus recombinant B subunit cholera vaccine in Peru'. Together they form a unique fingerprint.

Cite this