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

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

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

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Genevieve Losonsky Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland

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

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Jane Michalski Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland

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

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Robert Edelman Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland

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

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DOI:
https://doi.org/10.4269/ajtmh.1997.56.533
Volume/Issue:
Volume 56: Issue 5
Page(s):
533–537
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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.

Author Notes

Copyright:
Copyright © 1997 by The American Society of Tropical Medicine and Hygiene 1997
Published Online:
May 1997
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
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