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Infection and Immunity, August 2000, p. 4492-4497, Vol. 68, No. 8
0019-9567/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Safety and Immunogenicity of Two Different Lots of the Oral, Killed Enterotoxigenic Escherichia coli-Cholera Toxin B Subunit Vaccine in Israeli Young Adults

Dani Cohen,1,2,* Nadav Orr,1 Moti Haim,1 Shai Ashkenazi,1,2 Guy Robin,1 Manfred S. Green,1,2 Moshe Ephros,1,3 Tamar Sela,1 Raphael Slepon,1 Isaac Ashkenazi,1,4 David N. Taylor,5 Ann-Mari Svennerholm,6 Arieh Eldad,1,7 and Joshua Shemer1,2

Army Health Branch Research Unit, Medical Corps, Israel Defence Force,1 Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv,2 B. Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa,3 Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva,4 and Hebrew University and Hadassah Medical School, Jerusalem,7 Israel; Walter Reed Army Institute of Research, Washington, D.C.5; and University of Goteborg, Goteborg, Sweden6

Received 5 January 2000/Returned for modification 21 February 2000/Accepted 2 May 2000

Enterotoxigenic Escherichia coli (ETEC) is one of the leading causes of diarrhea among Israeli soldiers serving in field units. Two double-blind placebo-controlled, randomized trials were performed among 155 healthy volunteers to evaluate the safety and immunogenicity of different lots of the oral, killed ETEC vaccine consisting of two doses of whole cells plus recombinantly produced cholera toxin B subunit (rCTB). The two doses of vaccine lot E005 and the first dose of vaccine lot E003 were well tolerated by the volunteers. However, 5 (17%) vaccinees reported an episode of vomiting a few hours after the second dose of lot E003; none of the placebo recipients reported similar symptoms. Both lots of vaccine stimulated a rate of significant antibody-secreting cell (ASC) response to CTB and to colonization factor antigen I (CFA/I) after one or two doses, ranging from 85 to 100% and from 81 to 100%, respectively. The rate of ASC response to CS2, CS4, and CS5 was slightly lower than the rate of ASC response induced to CTB, CFA/I, and CS1. The second vaccine dose enhanced the response to CTB but did not increase the frequencies or magnitude of ASC responses to the other antigens. The two lots of the ETEC vaccine induced similar rates of serum antibody responses to CTB and CFA/I which were less frequent than the ASC responses to the same antigens. Based on these safety and immunogenicity data, an efficacy study of the ETEC vaccine is under way in the Israel Defense Force.

* Corresponding author. Mailing address: Military Post 02149, Israel Defence Force, Israel. Phone: 972-3-5307259. Fax: 972-3-9221962; E-mail: danic{at}netvision.net.il.

Infection and Immunity, August 2000, p. 4492-4497, Vol. 68, No. 8
0019-9567/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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