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Infection and Immunity, August 2000, p. 4492-4497, Vol. 68, No. 8
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.
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
*
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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