TY - JOUR
T1 - Two-year study of the protective efficacy of the oral whole cell plus recombinant B subunit cholera vaccine in Peru
AU - Taylor, David N.
AU - Cárdenas, Vicky
AU - Sanchez, José L.
AU - Bégué, Rodolfo E.
AU - Gilman, Robert
AU - Bautista, Christian
AU - Perez, Juan
AU - Puga, Romulo
AU - Gaillour, Alvaro
AU - Meza, Rina
AU - Echeverria, Peter
AU - Sadoff, Jerald
N1 - Funding Information:
Grant support: This work was supported by the US Army Medical Ma-tériel and Development Command, Fort Detrick, Maryland. The opinions and assertions contained herein are the private ones of the authors and are not to be construed as official or as reflecting the views of the Department of the Navy or the Peruvian government.
PY - 2000
Y1 - 2000
N2 - 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%).
AB - 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%).
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U2 - 10.1086/315462
DO - 10.1086/315462
M3 - Article
C2 - 10823767
AN - SCOPUS:0034043979
SN - 0022-1899
VL - 181
SP - 1667
EP - 1673
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 5
ER -