Initial Clinical Studies of CVD 112 Vibrio cholerae O139 Live Oral Vaccine: Safety and Efficacy against Experimental Challenge
- 1 September 1995
- journal article
- clinical trial
- Published by Oxford University Press (OUP) in The Journal of Infectious Diseases
- Vol. 172 (3) , 883-886
- https://doi.org/10.1093/infdis/172.3.883
Abstract
Since October 1992, epidemics of cholera associated with Vibrio eholerae 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 ΔaetxA Δzot Δace Δcep V. eholerae O139 vaccine strain, designated CVD 112. Six volunteers received 106 cfu and 6 received 108 cfu of CVD 112. No subject who received the 106 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 106 cfu of wild type V. eholerae 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%).Keywords
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