Safety and Immunogenicity of an Oral, Killed Enterotoxigenic Escherichia coli-Cholera Toxin B Subunit Vaccine in Egyptian Adults.
Savarino, Stephen J.; Brown, Matthew F. *; Hall, Eric; Bassily, Samir; Youssef, Fouad; Wierzba, Thomas; Peruski, Leonard; El-Masry, Nabil A.; Safwat, Mohammed; Rao, Malla; Jertborn, Marianne; Svennerholm, Ann-Mari; Lee, Young J.; Clemens, John D.
[Article] Journal of Infectious Diseases. 177(3):796-799, March 1998.

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: Enterotoxigenic Escherichia coli (ETEC) is the leading cause of bacterial diarrhea in young children in developing countries. The safety and immunogenicity of a killed, oral ETEC vaccine consisting of whole cells plus recombinantly produced cholera toxin B subunit (rCTB) was evaluated in Egypt, which is endemic for ETEC diarrhea. Seventy-four healthy Egyptian adults (21-45 years old) were randomized and received two doses of the ETEC/rCTB vaccine (E003) or placebo 2 weeks apart. The frequency of adverse events after either dose did not differ by treatment group, and no severe adverse events were reported. After vaccination, peripheral blood IgA B cell responses to CTB (100%) and to vaccine colonization factor antigens CFA/I (94%), CS4 (100%), CS2 (81%), and CS1 (69%) were significantly higher than response rates for the placebo group. These favorable results in Egyptian adults indicate that the ETEC/rCTB vaccine is a promising candidate for evaluation in younger age groups in this setting.

(C) Copyright Oxford University Press 1998.