Peru-15, a live attenuated oral cholera vaccine, is safe and immunogenic in Bangladeshi toddlers and infants.
A live oral Vibrio cholerae O1 El Tor vaccine, Peru-15 was tested in a double-blind, randomized placebo controlled study for safety and immunogenicity in Phase I and Phase II studies in 240 Bangladeshi children aged 9 months-5 years of age. Two different doses (2x10(7) and 2x10(8)cfu) were tested. Vaccination did not elicit adverse events and the strain was genetically stable. Vibriocidal antibody responses developed in 42/50 (84%) toddlers (2-5 years) and 35/50 (70%) of younger children (9-23 months) and overall 77/100 (77%) who received the high dose. LPS-IgA-antibody responses were seen in 60% of toddlers and 34% of infants; 40% responded with IgA antibodies to cholera toxin. The responses to the reduced dose was lower. These studies demonstrate that Peru-15 at a dose of 2x10(8)cfu is safe and immunogenic in children in Bangladesh.
Qadri
Firdausi
F
ICDDR,B: Centre for Health and Population Research, Bangladesh. fqadri@icddrb.org
Chowdhury
Mohiul I
MI
Faruque
Shah M
SM
Salam
Mohammed A
MA
Ahmed
Tanvir
T
Begum
Yasmin A
YA
Saha
Amit
A
Al Tarique
Abdullah
A
Seidlein
Lorenz V
LV
Park
Eunsik
E
Killeen
Kevin P
KP
Mekalanos
John J
JJ
Clemens
John D
JD
Sack
David A
DA
D000284:Administration, Oral; D000914:Antibodies, Viral / Q000097:blood; D002675:Child, Preschool; D022121:Cholera Vaccines / Q000009:adverse effects / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D008070:Lipopolysaccharides / Q000276:immunology; D008297:Male; D014613:Vaccines, Attenuated / Q000276:immunology
D000914:Antibodies, Viral; D022121:Cholera Vaccines; D007070:Immunoglobulin A; D008070:Lipopolysaccharides; C497037:Peru 15; D014613:Vaccines, Attenuated