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-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.
Savarino
S J
SJ
US Naval Medical Research Unit Number 3, Bethesda, MD, USA. savarino@namru3.navy.mil
Hall
E R
ER
Bassily
S
S
Brown
F M
FM
Youssef
F
F
Wierzba
T F
TF
Peruski
L
L
El-Masry
N A
NA
Safwat
M
M
Rao
M
M
El Mohamady
H
H
Abu-Elyazeed
R
R
Naficy
A
A
Svennerholm
A M
AM
Jertborn
M
M
Lee
Y J
YJ
Clemens
J D
JD
D000284:Administration, Oral; D000367:Age Factors; D000907:Antibodies, Bacterial / Q000097:blood; D001428:Bacterial Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D002772:Cholera Toxin / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D015331:Cohort Studies; D004311:Double-Blind Method; D004534:Egypt; D004926:Escherichia coli / Q000276:immunology*; D004927:Escherichia coli Infections / Q000517:prevention & control; D022361:Escherichia coli Vaccines; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D012449:Safety; D013997:Time Factors; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; D022361:Escherichia coli Vaccines; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D018074:Vaccines, Conjugate; D015164:Vaccines, Inactivated; D002772:Cholera Toxin