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Infection and Immunity, April 2002, p. 2016-2021, Vol. 70, No. 4
0019-9567/02/$04.00+0     DOI: 10.1128/IAI.70.4.2016-2021.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Phase I Evaluation of {Delta}virG Shigella sonnei Live, Attenuated, Oral Vaccine Strain WRSS1 in Healthy Adults

Karen L. Kotloff,1,2* David N. Taylor,3 Marcelo B. Sztein,1,2 Steven S. Wasserman,2 Genevieve A. Losonsky,1,2 James P. Nataro,1,2 Malabi Venkatesan,3 Antoinette Hartman,3 William D. Picking,4 David E. Katz,3 James D. Campbell,1,2 Myron M. Levine,1,2 and Thomas L. Hale3

Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics,1 Division of Geographic Medicine, Department of Medicine, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland 21201,2 Department of Enteric Infections, Walter Reed Army Institute of Research, Silver Spring, Maryland 20307,3 Department of Molecular Biosciences, University of Kansas, Lawrence, Kansas 660454

Received 28 September 2001/ Returned for modification 4 December 2001/ Accepted 11 January 2002

We conducted a phase I trial with healthy adults to evaluate WRSS1, a live, oral {Delta}virG Shigella sonnei vaccine candidate. In a double-blind, randomized, dose-escalating fashion, inpatient volunteers received a single dose of either placebo (n = 7) or vaccine (n = 27) at 3 x 103 CFU (group 1), 3 x 104 CFU (group 2), 3 x 105 CFU (group 3), or 3 x 106 CFU (group 4). The vaccine was generally well tolerated, although a low-grade fever or mild diarrhea occurred in six (22%) of the vaccine recipients. WRSS1 was recovered from the stools of 50 to 100% of the vaccinees in each group. The geometric mean peak anti-lipopolysaccharide responses in groups 1 to 4, respectively, were 99, 39, 278, and 233 for immunoglobulin (IgA) antibody-secreting cell counts; 401, 201, 533, and 284 for serum reciprocal IgG titers; and 25, 3, 489, and 1,092 for fecal IgA reciprocal titers. Postvaccination increases in gamma interferon production in response to Shigella antigens occurred in some volunteers. We conclude that WRSS1 vaccine is remarkably immunogenic in doses ranging from 103 to 106 CFU but elicits clinical reactions that must be assessed in further volunteer trials.

* Corresponding author. Mailing address: Center for Vaccine Development, University of Maryland School of Medicine, 685 West Baltimore St., HSF 480, Baltimore, MD 21201. Phone: (410) 706-5328. Fax: (410) 706-6205. E-mail: kkotloff{at}medicine.umaryland.edu.

Editor: J. D. Clements

Infection and Immunity, April 2002, p. 2016-2021, Vol. 70, No. 4
0019-9567/02/$04.00+0     DOI: 10.1128/IAI.70.4.2016-2021.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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