Oral, inactivated, whole cell enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine: results of the initial evaluation in children. PRIDE Study Group

Two randomized, double-blinded trials assessed the safety and immunogenicity of an oral, killed enterotoxigenic Escherichia coli (ETEC) plus cholera toxin B subunit vaccine in Egyptian children. Two doses of vaccine or E. coli K-12 were given 2 weeks apart to 105 6- to 12-year-olds and 97 2- to 5-ye...

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Bibliographic Details
Published in:The Journal of infectious diseases 1999-01, Vol.179 (1), p.107
Main Authors: Savarino, S J, Hall, E R, Bassily, S, Brown, F M, Youssef, F, Wierzba, T F, Peruski, L, El-Masry, N A, Safwat, M, Rao, M, El Mohamady, H, Abu-Elyazeed, R, Naficy, A, Svennerholm, A M, Jertborn, M, Lee, Y J, Clemens, J D
Format: Article
Language:English
Subjects:
Administration, Oral
Age Factors
Antibodies, Bacterial - blood
Bacterial Vaccines - administration & dosage
Bacterial Vaccines - adverse effects
Bacterial Vaccines - immunology
Child
Child, Preschool
Cholera Toxin - administration & dosage
Cholera Toxin - adverse effects
Cholera Toxin - immunology
Cohort Studies
Double-Blind Method
Egypt
Escherichia coli - immunology
Escherichia coli Infections - prevention & control
Escherichia coli Vaccines
Female
Humans
Immunoglobulin A - blood
Immunoglobulin G - blood
Male
Safety
Time Factors
Vaccines, Conjugate - administration & dosage
Vaccines, Conjugate - adverse effects
Vaccines, Conjugate - immunology
Vaccines, Inactivated - administration & dosage
Vaccines, Inactivated - adverse effects
Vaccines, Inactivated - immunology
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Summary:Two randomized, double-blinded trials assessed the safety and immunogenicity of an oral, killed enterotoxigenic Escherichia coli (ETEC) plus cholera toxin B subunit vaccine in Egyptian children. Two doses of vaccine or E. coli K-12 were given 2 weeks apart to 105 6- to 12-year-olds and 97 2- to 5-year-olds. Safety was monitored for 3 days after each dose. Blood was collected before immunization and 7 days after each dose to measure immune responses. Few children reported postdosing symptoms, with no differences in the frequency of symptoms between treatment groups. Most vaccinees had an IgA antibody-secreting cell response against colonization factor antigen I (100%, 6-12 years; 95%, 2-5 years), coli surface antigen 2 (92%, 6-12 years; 83%, 2-5 years), and coli surface antigen 4 (93%, 6-12 years). Vaccination evoked a >/=4-fold rise in antitoxic IgA and IgG titers in 93% and 81% of children, respectively. In conclusion, the oral ETEC vaccine was safe and immunogenic in 2- to 12-year-old children, justifying further evaluation in infants.
ISSN:0022-1899