title: Peru-15, a live attenuated oral cholera vaccine, is safe and immunogenic in Bangladeshi toddlers and infants.
abstract: 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.
authors.affiliation: ICDDR,B: Centre for Health and Population Research, Bangladesh. fqadri@icddrb.org
authors.forename: Firdausi
authors.initials: F
authors.lastname: Qadri
authors.forename: Mohiul I
authors.initials: MI
authors.lastname: Chowdhury
authors.forename: Shah M
authors.initials: SM
authors.lastname: Faruque
authors.forename: Mohammed A
authors.initials: MA
authors.lastname: Salam
authors.forename: Tanvir
authors.initials: T
authors.lastname: Ahmed
authors.forename: Yasmin A
authors.initials: YA
authors.lastname: Begum
authors.forename: Amit
authors.initials: A
authors.lastname: Saha
authors.forename: Abdullah
authors.initials: A
authors.lastname: Al Tarique
authors.forename: Lorenz V
authors.initials: LV
authors.lastname: Seidlein
authors.forename: Eunsik
authors.initials: E
authors.lastname: Park
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Killeen
authors.forename: John J
authors.initials: JJ
authors.lastname: Mekalanos
authors.forename: John D
authors.initials: JD
authors.lastname: Clemens
authors.forename: David A
authors.initials: DA
authors.lastname: Sack
mesh_terms: 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
chemical_list: D000914:Antibodies, Viral; D022121:Cholera Vaccines; D007070:Immunoglobulin A; D008070:Lipopolysaccharides; C497037:Peru 15; D014613:Vaccines, Attenuated