Peru-15, a live attenuated oral cholera vaccine, is safe and immunogenic in Bangladeshi toddlers and infants

Firdausi Qadri; Mohiul I. Chowdhury; Shah M. Faruque; Mohammed A. Salam; Tanvir Ahmed; Yasmin A. Begum; Amit Saha; Abdullah Al Tarique; Lorenz V. Seidlein; Eunsik Park; Kevin P. Killeen; John J. Mekalanos; John D. Clemens; David A. Sack

doi:10.1016/j.vaccine.2006.08.031

Peru-15, a live attenuated oral cholera vaccine, is safe and immunogenic in Bangladeshi toddlers and infants

Firdausi Qadri, Mohiul I. Chowdhury, Shah M. Faruque, Mohammed A. Salam, Tanvir Ahmed, Yasmin A. Begum, Amit Saha, Abdullah Al Tarique, Lorenz V. Seidlein, Eunsik Park, Kevin P. Killeen, John J. Mekalanos, John D. Clemens, David A. Sack

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78 Scopus citations

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 (2 × 10⁷ and 2 × 10⁸ 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 2 × 10⁸ cfu is safe and immunogenic in children in Bangladesh.

Original language	English (US)
Pages (from-to)	231-238
Number of pages	8
Journal	Vaccine
Volume	25
Issue number	2
DOIs	https://doi.org/10.1016/j.vaccine.2006.08.031
State	Published - Jan 4 2007
Externally published	Yes

Keywords

Bangladeshi children
Immunogenicity
Peru-15

ASJC Scopus subject areas

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

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10.1016/j.vaccine.2006.08.031

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Qadri, F., Chowdhury, M. I., Faruque, S. M., Salam, M. A., Ahmed, T., Begum, Y. A., Saha, A., Al Tarique, A., Seidlein, L. V., Park, E., Killeen, K. P., Mekalanos, J. J., Clemens, J. D., & Sack, D. A. (2007). Peru-15, a live attenuated oral cholera vaccine, is safe and immunogenic in Bangladeshi toddlers and infants. Vaccine, 25(2), 231-238. https://doi.org/10.1016/j.vaccine.2006.08.031

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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 (2 × 107 and 2 × 108 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 2 × 108 cfu is safe and immunogenic in children in Bangladesh.",

keywords = "Bangladeshi children, Immunogenicity, Peru-15",

author = "Firdausi Qadri and Chowdhury, {Mohiul I.} and Faruque, {Shah M.} and Salam, {Mohammed A.} and Tanvir Ahmed and Begum, {Yasmin A.} and Amit Saha and {Al Tarique}, Abdullah and Seidlein, {Lorenz V.} and Eunsik Park and Killeen, {Kevin P.} and Mekalanos, {John J.} and Clemens, {John D.} and Sack, {David A.}",

note = "Funding Information: This work was supported by the Diseases of the Most Impoverished Program, funded by the Bill and Melinda Gates Foundation and coordinated by the International Vaccine Institute (Grant No. C-5).",

year = "2007",

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doi = "10.1016/j.vaccine.2006.08.031",

language = "English (US)",

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T1 - Peru-15, a live attenuated oral cholera vaccine, is safe and immunogenic in Bangladeshi toddlers and infants

AU - Qadri, Firdausi

AU - Chowdhury, Mohiul I.

AU - Faruque, Shah M.

AU - Salam, Mohammed A.

AU - Ahmed, Tanvir

AU - Begum, Yasmin A.

AU - Saha, Amit

AU - Al Tarique, Abdullah

AU - Seidlein, Lorenz V.

AU - Park, Eunsik

AU - Killeen, Kevin P.

AU - Mekalanos, John J.

AU - Clemens, John D.

AU - Sack, David A.

N1 - Funding Information: This work was supported by the Diseases of the Most Impoverished Program, funded by the Bill and Melinda Gates Foundation and coordinated by the International Vaccine Institute (Grant No. C-5).

PY - 2007/1/4

Y1 - 2007/1/4

N2 - 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 (2 × 107 and 2 × 108 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 2 × 108 cfu is safe and immunogenic in children in Bangladesh.

AB - 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 (2 × 107 and 2 × 108 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 2 × 108 cfu is safe and immunogenic in children in Bangladesh.

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KW - Immunogenicity

KW - Peru-15

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Peru-15, a live attenuated oral cholera vaccine, is safe and immunogenic in Bangladeshi toddlers and infants

Abstract

Keywords

ASJC Scopus subject areas

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