This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrowReprints and Permissions
Right arrow Copyright Information
Right arrow Books from ASM Press
Right arrow MicrobeWorld
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Lapa, J. A.
Right arrow Articles by Tribble, D. R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Lapa, J. A.
Right arrow Articles by Tribble, D. R.

 Previous Article  |  Next Article 

Clinical and Vaccine Immunology, August 2008, p. 1222-1228, Vol. 15, No. 8
1071-412X/08/$08.00+0     doi:10.1128/CVI.00491-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Randomized Clinical Trial Assessing the Safety and Immunogenicity of Oral Microencapsulated Enterotoxigenic Escherichia coli Surface Antigen 6 with or without Heat-Labile Enterotoxin with Mutation R192G{triangledown}

Joyce A. Lapa,1* Stephanie A. Sincock,1,{dagger} Madhumita Ananthakrishnan,2,{ddagger} Chad K. Porter,1 Frederick J. Cassels,2,§ Carl Brinkley,2,¶ Eric R. Hall,1,|| John van Hamont,2,{dagger}{dagger} Joseph D. Gramling,3,{ddagger}{ddagger} Colleen M. Carpenter,1 S. Baqar,1 and David R. Tribble1,§§

Naval Medical Research Center, Silver Spring, 503 Robert Grant Avenue, Silver Spring, Maryland 20910,1 Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, Maryland 20910,2 Walter Reed Army Medical Center, 6900 Georgia Avenue NW, Washington, DC 203073

Received 18 December 2007/ Returned for modification 9 March 2008/ Accepted 18 June 2008

An oral, microencapsulated anti-colonization factor 6 antigen (meCS6) vaccine, with or without heat-labile enterotoxin with mutation R192G (LTR192G) (mucosal adjuvant), against enterotoxigenic Escherichia coli (ETEC) was evaluated for regimen and adjuvant effects on safety and immunogenicity. Sixty subjects were enrolled into a three-dose, 2-week interval or four-dose, 2-day interval regimen. Each regimen was randomized into two equal groups of meCS6 alone (1 mg) or meCS6 with adjuvant (2 µg of LTR192G). The vaccine was well tolerated and no serious adverse events were reported. Serologic response to CS6 was low in all regimens (0 to 27%). CS6-immunogloublin A (IgA) antibody-secreting cell (ASC) responses ranged from 36 to 86%, with the highest level in the three-dose adjuvanted regimen; however, the magnitude was low. As expected, serologic and ASC LT responses were limited to adjuvanted regimens, with the exception of fecal IgA, which appeared to be nonspecific to LT administration. Further modifications to the delivery strategy and CS6 and adjuvant dose optimization will be needed before conducting further clinical trials with this epidemiologically important class of ETEC.

* Corresponding author. Mailing address: Naval Medical Research Center, 503 Robert Grant Avenue, Silver Spring, MD 20910-7500. Phone: (301) 319-7664. Fax: (301) 319-7679. E-mail: joyce.lapa{at}med.navy.mil

{triangledown} Published ahead of print on 25 June 2008.

{dagger} Present address: National Naval Medical Center, 8901 Rockville Pike, Bethesda, MD 20889-5600.

{ddagger} Present address: 2200 Children's Way, 5121 Doctors' Office Tower, Nashville, TN 37232-9075.

§ Present address: Influenza, SARS, and Related Viral Respiratory Diseases Section, RDB/DMID/NIAID/NIH/DHHS, Room 5077, 6610 Rockledge Drive, Bethesda, MD 20892-7630.

Present address: Microbiology Branch, U.S. Army Medical Department Center & School, 3151 Scott Rd., Bldg. 2811 (Willis Hall), Fort Sam Houston, TX 78234.

|| Present address: Bacteriology Program, Naval Medical Research Center Detachment Unit 3800, APO AA 34031-3800.

{dagger}{dagger} Present address: AMEDD Center and School, JBAIDS Training Facility, 2507 Kennedy Circle, Bldg. 110, Brooks City Base, San Antonio, TX 78235-5116.

{ddagger}{ddagger} Present address: Pediatric Department, Madigan Army Medical Center, Bldg. 9040, Fitzsimmons Drive, Tacoma, WA 98431.

§§ Present address: Infectious Disease Clinical Research Program, Preventive Medicine & Biometrics Department, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814-5119.

Clinical and Vaccine Immunology, August 2008, p. 1222-1228, Vol. 15, No. 8
1071-412X/08/$08.00+0     doi:10.1128/CVI.00491-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.





Copyright © 2009 by the American Society for Microbiology.   For an alternate route to Journals.ASM.org, visit: http://intl-journals.asm.org | More Info»