NDLI: Randomized, Double-Blind, Placebo-Controlled, Multicentered Trialof the Efficacy of a Single Dose of Live Oral Cholera Vaccine CVD103-HgR in Preventing Cholera following Challenge with Vibriocholerae O1 El Tor Inaba Three Months after Vaccination

Content Provider	PubMed Central
Author	Tacket, Carol O. Cohen, Mitchell B. Wasserman, Steven S. Genevieve, Losonsky Livio, Sofie Karen, Kotloff Edelman, Robert Kaper, James B. Cryz, Stanley J. Giannella, Ralph A. Schiff, Gilbert Levine, Myron M.
Editor	Burns, D. L.
Copyright Year	1999
Abstract	CVD 103-HgR is a live oral cholera vaccine strain constructed bydeleting 94% of the gene for the enzymatically active A subunit ofcholera toxin from classical Inaba Vibrio cholerae O1 569B;the strain also contains a mercury resistance gene as an identifyingmarker. This vaccine was well tolerated and immunogenic indouble-blind, controlled studies and was protective in open-labelstudies of volunteers challenged with V. cholerae O1. Arandomized, double-blind, placebo-controlled, multicenter study ofvaccine efficacy was designed to test longer-term protection of CVD103-HgR against moderate and severe El Tor cholera in U.S. volunteers.A total of 85 volunteers (50 at the University of Maryland and 35 atChildren's Hospital Medical Center/University of Cincinnati)were recruited for vaccination and challenge with wild-type V.cholerae El Tor Inaba. Volunteers wererandomized in a double-blind manner to receive, with buffer, a singleoral dose of either CVD 103-HgR (2 × 108to 8 × 108 CFU) or placebo (killed E.coli K-12). About 3 months after immunization, 51 of thesevolunteers were orally challenged with 105 CFU ofvirulent V. cholerae O1 El Tor Inaba strain N16961,prepared from a standardized frozen inoculum. Ninety-onepercent of the vaccinees had a ≥4-fold rise in serum vibriocidalantibodies after vaccination. After challenge, 9 (39%) of the 23placebo recipients and 1 (4%) of the 28 vaccinees had moderate orsevere diarrhea (≥3-liter diarrheal stool) (P <0.01; protective efficacy, 91%). A total of 21 (91%) of 23 placeborecipients and 5 (18%) of 28 vaccinees had any diarrhea(P < 0.001; protective efficacy, 80%). Peak stoolV. cholerae excretion among placebo recipients was 1.1× 107 CFU/g and among vaccinees was 4.9 ×102 CFU/g (P < 0.001). This vaccine couldtherefore be a safe and effective tool to prevent cholera intravelers.
Starting Page	6341
File Format	PDF
ISSN	10985522
e-ISSN	10985522
Journal	Infection and Immunity
Issue Number	12
Volume Number	67
Language	English
Publisher	American Society for Microbiology (ASM)
Publisher Date	1999-12-01
Access Restriction	Open
Rights Holder	American Society for Microbiology (ASM)
Subject Keyword	Research in Higher Education
Content Type	Text
Resource Type	Article
Subject	Infectious Diseases Parasitology Immunology Microbiology

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