Two-Year Study of the Protective Efficacy of the Oral Whole Cell plus Recombinant B Subunit Cholera Vaccine in Peru

• Published in: The Journal of infectious diseases Vol. 181; no. 5; pp. 1667 - 1673
• Main Authors: Taylor, David N., Cárdenas, Vicky, Sanchez, José L., Bégué, Rodolfo E., Gilman, Robert, Bautista, Christian, Perez, Juan, Puga, Romulo, Gaillour, Alvaro, Meza, Rina, Echeverria, Peter, Sadoff, Jerald
• Format: Journal Article
• Language: English
• Published: Chicago, IL The University of Chicago Press 01.05.2000; University of Chicago Press; Oxford University Press
• Subjects: Administration, Oral; Adolescent; Adult; Aged; Antibodies; Bacteriology; Biological and medical sciences; Child; Child, Preschool; Cholera; Cholera - epidemiology; Cholera - immunology; Cholera - prevention & control; Cholera Toxin - administration & dosage; Cholera Toxin - immunology; Cholera vaccine; Cholera Vaccines - administration & dosage; Diarrhea; Diarrhea - virology; Dosage; Feces - microbiology; Fundamental and applied biological sciences. Psychology; Humans; Major Articles; Microbiology; Middle Aged; Pampas; Peru; Peru - epidemiology; Placebos; Population Surveillance; Surveillance; Toxins; Tropical medicine; Vaccination; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies; Vaccines, Synthetic - administration & dosage; Vibrio cholerae; Vibrio cholerae - immunology; Vibrio cholerae - isolation & purification; Virus Shedding; South America; Peru; America; Human; Vibrio cholerae; Vaccine; Infection; Prevention; Immunoprophylaxis; Efficiency; Bacteriosis; Digestive diseases; Bacteria; Vibrionaceae; Adult; Cholera; Child
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/315462

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%).