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Infect Immun, May 1998, p. 1968-1972, Vol. 66, No. 5
0019-9567/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

Validation of a Volunteer Model of Cholera with Frozen Bacteria as the Challenge

David A. Sack,1,* Carol O. Tacket,2 Mitchell B. Cohen,3 R. Bradley Sack,1 Genevieve A. Losonsky,2 Janet Shimko,1 James P. Nataro,2 Robert Edelman,2 Myron M. Levine,2 Ralph A. Giannella,3 Gilbert Schiff,3 and Dennis Lang4

The Vaccine Testing Unit, Department of International Health, Johns Hopkins University,1 and The Center for Vaccine Development, University of Maryland School of Medicine,2 Baltimore, and National Institute of Allergy and Infectious Diseases, Bethesda,4 Maryland, and Children's Hospital Medical Center and University of Cincinnati, Cincinnati, Ohio3

Received 15 September 1997/Returned for modification 12 December 1997/Accepted 2 February 1998

To evaluate a standardized inoculum of Vibrio cholerae for volunteer challenge studies, 40 healthy adult volunteers were challenged at three different institutions with a standard inoculum prepared directly from vials of frozen, virulent, El Tor Inaba V. cholerae N16961, with no further incubation. Groups of 5 volunteers, with each group including 2 volunteers with blood group O, were given a dose of 105 CFU, and 34 of the 40 volunteers developed diarrhea (mean incubation time, 28 h). Transient fevers occurred in 15 (37.5%) of the volunteers. V. cholerae was excreted by 36 of 40 volunteers. Five additional volunteers received 104 CFU, and four developed diarrhea but with a lower average purging rate than required for the model. Of the 40 volunteers, 37 developed rises in their vibriocidal and antitoxin titers similar to those in previous groups challenged with freshly harvested bacteria. We conclude that challenge with frozen bacteria results in a reproducible illness similar to that induced by freshly harvested bacteria. Use of this model should minimize differences in attack rates or severity when groups are challenged at different times and in different institutions.

* Corresponding author. Mailing address: Johns Hopkins University Vaccine Testing Unit, 550 N. Broadway, Suite 1001, Baltimore, MD 21205. Phone: (410) 955-0053. Fax: (410) 614-9483. E-mail: dsack{at}jhsph.edu.

Infect Immun, May 1998, p. 1968-1972, Vol. 66, No. 5
0019-9567/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.


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