Randomized, controlled study of the safety and immunogenicity of Peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in Bangladesh

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

Research output: Contribution to journalArticle

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 (∼2 × 10 8 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

Original languageEnglish (US)
Pages (from-to)573-579
Number of pages7
JournalJournal of Infectious Diseases
Volume192
Issue number4
DOIs
StatePublished - Aug 15 2005
Externally publishedYes

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Attenuated Vaccines
Bangladesh
Cholera
Volunteers
Vaccines
Safety
Placebos
Immunoglobulin A
Lipopolysaccharides
Inpatients
Buffers
Outpatients
Vibrio cholerae O1
Antibody-Producing Cells
Vibrio cholerae
Bicarbonates
Ascorbic Acid
Antibody Formation
Immunoglobulin M
Peru 15

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

Cite this

Randomized, controlled study of the safety and immunogenicity of Peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in Bangladesh. / Qadri, Firdausi; Chowdhury, Mohiul I.; Faruque, Shah M.; Salam, Mohammed A.; Ahmed, Tanvir; Begum, Yasmin A.; Saha, Amit; Alam, Mohammed S.; Zaman, K.; Seidlein, Lorenz V.; Park, Eunsik; Killeen, Kevin P.; Mekalanos, John J.; Clemens, John D.; Sack, David A.

In: Journal of Infectious Diseases, Vol. 192, No. 4, 15.08.2005, p. 573-579.

Research output: Contribution to journalArticle

Qadri, F, Chowdhury, MI, Faruque, SM, Salam, MA, Ahmed, T, Begum, YA, Saha, A, Alam, MS, Zaman, K, Seidlein, LV, Park, E, Killeen, KP, Mekalanos, JJ, Clemens, JD & Sack, DA 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', Journal of Infectious Diseases, vol. 192, no. 4, pp. 573-579. https://doi.org/10.1086/432074
Qadri, Firdausi ; Chowdhury, Mohiul I. ; Faruque, Shah M. ; Salam, Mohammed A. ; Ahmed, Tanvir ; Begum, Yasmin A. ; Saha, Amit ; Alam, Mohammed S. ; Zaman, K. ; Seidlein, Lorenz V. ; Park, Eunsik ; Killeen, Kevin P. ; Mekalanos, John J. ; Clemens, John D. ; Sack, David A. / Randomized, controlled study of the safety and immunogenicity of Peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in Bangladesh. In: Journal of Infectious Diseases. 2005 ; Vol. 192, No. 4. pp. 573-579.
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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 (∼2 × 10 8 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",
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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.

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Y1 - 2005/8/15

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 (∼2 × 10 8 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

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