Safety and Immunogenicity of an Oral, Killed Enterotoxigenic Escherichia coli-Cholera Toxin B Subunit Vaccine in Egyptian Adults

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, whic...

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Veröffentlicht in:The Journal of infectious diseases 1998-03, Vol.177 (3), p.796-799
Hauptverfasser: Savarino, Stephen J., Brown, F. Matthew, 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.
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Sprache:eng
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Zusammenfassung: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.
ISSN:0022-1899
1537-6613
DOI:10.1086/517812