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Infection and Immunity, May 2001, p. 2853-2857, Vol. 69, No. 5
0019-9567/01/$04.00+0   DOI: 10.1128/IAI.69.5.2853-2857.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Induction of Systemic Antifimbria and Antitoxin Antibody Responses in Egyptian Children and Adults by an Oral, Killed Enterotoxigenic Escherichia coli plus Cholera Toxin B Subunit Vaccine

Eric R. Hall,1,dagger ,§ Thomas F. Wierzba,1,§ Christina Åhrén,2,§ Malla R. Rao,3,§ Samir Bassily,1,§ Wagdy Francis,1,§ Fouad Y. Girgis,1,§ Mohamed Safwat,4,§ Young J. Lee,3,§ Ann-Mari Svennerholm,2,§ John D. Clemens,3,Dagger ,§ and Stephen J. Savarino1,*,§

U.S. Naval Medical Research Unit No. Three, Cairo,1 and Egyptian Ministry of Health and Population, Benha, Qalyubia Governorate,4 Egypt; Department of Medical Microbiology and Immunology, University of Göteborg, Sweden2; and Division of Epidemiology, Statistics and Prevention Research, National Institute of Child Health and Human Development, Bethesda, Maryland3

Received 18 October 2000/Returned for modification 5 December 2000/Accepted 7 February 2001

We assessed serologic responses to an oral, killed whole-cell enterotoxigenic Escherichia coli plus cholera toxin B-subunit (ETEC-rCTB) vaccine in 73 Egyptian adults, 105 schoolchildren, and 93 preschool children. Each subject received two doses of vaccine or placebo 2 weeks apart, giving blood before immunization and 7 days after each dose. Plasma antibodies to rCTB and four vaccine-shared colonization factors (CFs) were measured by enzyme-linked immunosorbent assay. Immunoglobulin A (IgA) antibodies to rCTB and CFA/I were measured in all subjects, and those against CS1, CS2, and CS4 were measured in all children plus a subset of 33 adults. IgG antibodies to these five antigens were measured in a subset of 30 to 33 subjects in each cohort. Seroconversion was defined as a >2-fold increase in titer after vaccination. IgA and IgG seroconversion to rCTB was observed in 94 to 95% of adult vaccinees, with titer increases as robust as those previously reported for these two pediatric cohorts. The proportion showing IgA seroconversion to each CF antigen among vaccinated children (range, 70 to 96%) and adults (31 to 69%), as well as IgG seroconversion in children (44 to 75%) and adults (25 to 81%), was significantly higher than the corresponding proportion in placebo recipients, except for IgA responses to CS2 in adults. IgA anti-CF titers peaked after one dose in children, whereas in all age groups IgG antibodies rose incrementally after each dose. Independently, both preimmunization IgA titer and age were inversely related to the magnitude of IgA responses. In conclusion, serologic responses to the ETEC-rCTB vaccine may serve as practical immune outcome measures in future pediatric trials in areas where ETEC is endemic.

* Corresponding author. Present address: Enteric Diseases Department, Naval Medical Research Center, 503 Robert Grant Ave., Silver Spring, MD 20910. Phone: (301) 319-7663. Fax: (301) 319-7679. E-mail: savarinos{at}nmrc.navy.mil.

dagger Present address: Enteric Diseases Department, Naval Medical Research Center, Silver Spring, Maryland.

Dagger Present address: International Vaccine Institute, Seoul, Korea.

§ Member of the Pediatric Research on Immunization against Diarrhea in Egypt (PRIDE) Study Group, which includes Robert Frenck, Remon Abu Elyazeed, Nemat El Ghorab, Leonard F. Peruski, Jr., Karim Kamal, Ibrahim Abdel-Messih, Hanan El Mohamady, and Hind Shaheen, U.S. Naval Medical Research Unit No. 3, Cairo, Egypt; Abdollah Naficy and Patricia Moyer, National Institute of Child Health and Human Development, Bethesda, Md.; Anwar A. Latif, Abdel Fattah Ahmed, Abdel Kader Ahmed, Mokhtar A. Aty, and Mohamed I. Ibrahim, Ministry of Health and Population, Qalyubia Governorate, Egypt; and Marianne Jertborn, University of Göteborg, Sweden.

Infection and Immunity, May 2001, p. 2853-2857, Vol. 69, No. 5
0019-9567/01/$04.00+0   DOI: 10.1128/IAI.69.5.2853-2857.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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