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Randomized, controlled study of the safety and immunogenicity of Peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in Bangladesh.
J Infect Dis. 2005 Aug 15; 192(4):573-9.JI

Abstract

BACKGROUND

A live oral Vibrio cholerae O1 El Tor vaccine candidate, Peru-15, was studied for safety, immunogenicity, and excretion in phase 1 (inpatient) and phase 2 (outpatient) studies of Bangladeshi adults.METHODs. The study was conducted among adults, by use of a double-blind, randomized, placebo-controlled design. A single dose of Peru-15 (approximately 2 x 108 cfu) or placebo (buffer only) was given in standard bicarbonate and ascorbic acid buffer.RESULTS. Study treatment did not elicit any major adverse events in the volunteers, during either the inpatient or the outpatient phases, and there were no reports of diarrhea. V. cholerae was isolated from the stool of only 1 volunteer and was found to be genetically identical to the vaccine strain. Vibriocidal antibody responses were seen in 30 (75%) of 40 vaccine recipients and in 3 (10%) of 30 placebo recipients. Peripheral blood immunoglobulin (Ig) A and IgM antibody-secreting cell responses to lipopolysaccharide were seen in the majority of vaccine recipients (response rate, 78%--88%). Seroconversion for lipopolysaccharide-specific IgA antibodies was seen in 88% of vaccine recipients. The response in vaccine recipients was significantly higher than that in placebo recipients, in all of the immunological assays (P=.036 to <.001). A lower immunological response against cholera toxin B subunit was detected.CONCLUSIONS. The safety and immunogenicity of this Peru-15 vaccine candidate indicates the usefulness of future studies in Bangladesh, where cholera is endemic.

Authors+Show Affiliations

International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B): Centre for Health and Population Research, Dhaka, Bangladesh. fqadri@icddrb.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16028125

Citation

Qadri, Firdausi, et al. "Randomized, Controlled Study of the Safety and Immunogenicity of Peru-15, a Live Attenuated Oral Vaccine Candidate for Cholera, in Adult Volunteers in Bangladesh." The Journal of Infectious Diseases, vol. 192, no. 4, 2005, pp. 573-9.
Qadri F, Chowdhury MI, Faruque SM, et al. Randomized, controlled study of the safety and immunogenicity of Peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in Bangladesh. J Infect Dis. 2005;192(4):573-9.
Qadri, F., Chowdhury, M. I., Faruque, S. M., Salam, M. A., Ahmed, T., Begum, Y. A., Saha, A., Alam, M. S., Zaman, K., Seidlein, L. V., Park, E., Killeen, K. P., Mekalanos, J. J., Clemens, J. D., & Sack, D. A. (2005). Randomized, controlled study of the safety and immunogenicity of Peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in Bangladesh. The Journal of Infectious Diseases, 192(4), 573-9.
Qadri F, et al. Randomized, Controlled Study of the Safety and Immunogenicity of Peru-15, a Live Attenuated Oral Vaccine Candidate for Cholera, in Adult Volunteers in Bangladesh. J Infect Dis. 2005 Aug 15;192(4):573-9. PubMed PMID: 16028125.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, controlled study of the safety and immunogenicity of Peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in Bangladesh. 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 - Alam,Mohammed S, AU - Zaman,K, AU - Seidlein,Lorenz V, AU - Park,Eunsik, AU - Killeen,Kevin P, AU - Mekalanos,John J, AU - Clemens,John D, AU - Sack,David A, AU - ,, Y1 - 2005/07/15/ PY - 2005/01/30/received PY - 2005/03/23/accepted PY - 2005/7/20/pubmed PY - 2005/9/27/medline PY - 2005/7/20/entrez SP - 573 EP - 9 JF - The Journal of infectious diseases JO - J. Infect. Dis. VL - 192 IS - 4 N2 - BACKGROUND: A live oral Vibrio cholerae O1 El Tor vaccine candidate, Peru-15, was studied for safety, immunogenicity, and excretion in phase 1 (inpatient) and phase 2 (outpatient) studies of Bangladeshi adults.METHODs. The study was conducted among adults, by use of a double-blind, randomized, placebo-controlled design. A single dose of Peru-15 (approximately 2 x 108 cfu) or placebo (buffer only) was given in standard bicarbonate and ascorbic acid buffer.RESULTS. Study treatment did not elicit any major adverse events in the volunteers, during either the inpatient or the outpatient phases, and there were no reports of diarrhea. V. cholerae was isolated from the stool of only 1 volunteer and was found to be genetically identical to the vaccine strain. Vibriocidal antibody responses were seen in 30 (75%) of 40 vaccine recipients and in 3 (10%) of 30 placebo recipients. Peripheral blood immunoglobulin (Ig) A and IgM antibody-secreting cell responses to lipopolysaccharide were seen in the majority of vaccine recipients (response rate, 78%--88%). Seroconversion for lipopolysaccharide-specific IgA antibodies was seen in 88% of vaccine recipients. The response in vaccine recipients was significantly higher than that in placebo recipients, in all of the immunological assays (P=.036 to <.001). A lower immunological response against cholera toxin B subunit was detected.CONCLUSIONS. The safety and immunogenicity of this Peru-15 vaccine candidate indicates the usefulness of future studies in Bangladesh, where cholera is endemic. SN - 0022-1899 UR - https://www.unboundmedicine.com/medline/citation/16028125/Randomized_controlled_study_of_the_safety_and_immunogenicity_of_Peru_15_a_live_attenuated_oral_vaccine_candidate_for_cholera_in_adult_volunteers_in_Bangladesh_ L2 - https://academic.oup.com/jid/article-lookup/doi/10.1086/432074 DB - PRIME DP - Unbound Medicine ER -