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Infection and Immunity, April 2002, p. 1874-1880, Vol. 70, No. 4
0019-9567/02/$04.00+0     DOI: 10.1128/IAI.70.4.1874-1880.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Safety and Immunogenicity of a Prototype Enterotoxigenic Escherichia coli Vaccine Administered Transcutaneously

Fernando Güereña-Burgueño,1* Eric R. Hall,2 David N. Taylor,1 Frederick J. Cassels,1 Daniel A. Scott,2 Marcia K. Wolf,1 Zachary J. Roberts,2 Galina V. Nesterova,3 Carl R. Alving,4 and Gregory M. Glenn5

Department of Enteric Infections,1 Department of Clinical Trials,3 Department of Membrane Biochemistry, Walter Reed Army Institute of Research,4 Enteric Diseases Department, Naval Medical Research Center, Silver Spring, Maryland 20910-7500,2 IOMAI Corporation, Gaithersburg, Maryland 208785

Received 24 September 2001/ Returned for modification 29 November 2001/ Accepted 7 January 2002

Transcutaneous immunization (TCI) is a new method for vaccine delivery that has been shown to induce immunity relevant to enteric disease vaccines. We evaluated the clinical safety and immunogenicity of a recombinant subunit vaccine against enterotoxigenic Escherichia coli (ETEC) delivered by TCI. Adult volunteers received patches containing the recombinant ETEC colonization factor CS6, either with heat-labile enterotoxin (LT) or patches containing CS6 alone. The vaccine was administered at 0, 1, and 3 months, and serum antibodies and antibody-secreting cells (ASCs) were assessed. Among the 26 volunteers that completed the trial, there were no responses to CS6 in the absence of LT. In the groups receiving both CS6 and LT, 68 and 53% were found to have serum anti-CS6 immunoglobulin G (IgG) and IgA, respectively; 37 and 42% had IgG and IgA anti-CS6 ASCs. All of the volunteers receiving LT had anti-LT IgG, and 90% had serum anti-LT IgA; 79 and 37% had anti-LT IgG and IgA ASCs. Delayed-type hypersensitivity (DTH), suggesting T-cell responses, was seen in 14 of 19 volunteers receiving LT and CS6; no DTH was seen in subjects receiving CS6 alone. This study demonstrated that protein antigens delivered by a simple patch could induce significant systemic immune responses but only in the presence of an adjuvant such as LT. The data suggest that an ETEC vaccine for travelers delivered by a patch may be a viable approach worthy of further evaluation.

* Corresponding author. Mailing address: Department of Enteric Infections, Division of Communicable Diseases and Immunology, Walter Reed Army Institute of Research, 503 Robert Grant Rd., Silver Spring, MD 20910-7500. Phone: (301) 319-9982. Fax: (301) 319-9801. E-mail: Fernando.Guerena{at}NA.AMEDD.ARMY.MIL.

Editor: D. L. Burns

Infection and Immunity, April 2002, p. 1874-1880, Vol. 70, No. 4
0019-9567/02/$04.00+0     DOI: 10.1128/IAI.70.4.1874-1880.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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