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Initial clinical studies of CVD 112 Vibrio cholerae O139 live oral vaccine: safety and efficacy against experimental challenge.

Abstract
Since October 1992, epidemics of cholera associated with Vibrio cholerae O group 139 have occurred in India, Bangladesh, and much of the rest of Asia. A volunteer model was used to determine the safety, immunogenicity, and efficacy of an attenuated delta ctxA delta zot delta ace delta cep V. cholerae O139 vaccine strain, designated CVD 112. Six volunteers received 10(6) cfu and 6 received 10(8) cfu of CVD 112. No subject who received the 10(6) dose had diarrhea or other severe symptoms after vaccination; 3 vaccinees developed mild diarrhea (mean stool volume, 648 mL) after receiving the higher dose. Five weeks after vaccination, 8 vaccinees and 15 unvaccinated control subjects underwent challenge with 10(6) cfu of wild type V. cholerae O139 AI1837. One vaccinee (13%) and 12 control subjects (80%) developed diarrhea after challenge (P = .003). The short-term protective efficacy conferred by vaccine strain CVD 112 was 84% and was remarkably similar to that conferred by primary wild type clinical infection (80%).
AuthorsC O Tacket, G Losonsky, J P Nataro, L Comstock, J Michalski, R Edelman, J B Kaper, M M Levine
JournalThe Journal of infectious diseases (J Infect Dis) Vol. 172 Issue 3 Pg. 883-6 (Sep 1995) ISSN: 0022-1899 [Print] United States
PMID7658089 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Antibodies, Bacterial
  • Bacterial Vaccines
  • CVD 112
  • Cholera Vaccines
  • Immunoglobulin A
  • Vaccines, Attenuated
Topics
  • Administration, Oral
  • Adolescent
  • Adult
  • Antibodies, Bacterial (blood)
  • Asia (epidemiology)
  • Bacterial Vaccines (administration & dosage, immunology, toxicity)
  • Bangladesh (epidemiology)
  • Cholera (epidemiology, immunology, prevention & control)
  • Cholera Vaccines
  • Dose-Response Relationship, Drug
  • Humans
  • Immunoglobulin A (biosynthesis)
  • India (epidemiology)
  • Vaccines, Attenuated (administration & dosage, immunology, toxicity)
  • Vibrio cholerae (genetics, immunology)

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