Volunteer Studies Investigating the Safety and Efficacy of Live Oral El Tor Vibrio cholerae O1 Vaccine Strain CVD 111

Carol O. TacketCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland

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Karen L. KotloffCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland

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Genevieve LosonskyCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland

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James P. NataroCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland

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Jane MichalskiCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland

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James B. KaperCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland

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Robert EdelmanCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland

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Myron M. LevineCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland

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A live oral cholera vaccine should ideally protect against both classical and El Tor biotypes of Vibrio cholerae O1. An El Tor biotype vaccine strain, therefore, would complement classical cholera vaccine strain CVD 103-HgR, a strain already in use in some countries. In this study, 25 healthy adult volunteers received a single dose of 108 colony-forming units of El Tor vaccine strain CVD 111, a derivative of El Tor Ogawa strain N16117 deleted in the virulence cassette. Three (12%) volunteers developed mild diarrhea (mean stool volume = 813 ml) but no systemic symptoms; 23 (92%) of the 25 volunteers developed serum vibriocidal antibodies (geometric mean titer = 1: 2,291). Five weeks after vaccination, 18 vaccinees and eight unimmunized control volunteers underwent wild-type challenge with El Tor Ogawa strain 3008. Three (16.7%) of 18 vaccinees and seven (87.5%) of eight controls developed diarrhea (P = 0.001) (vaccine efficacy = 80.9%). Further studies are underway to determine a dosage of CVD 111 that will be more clinically acceptable but equally immunogenic and protective.

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