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Vibriocidal Antibody Responses to a Bivalent Killed Whole-Cell Oral Cholera Vaccine in a Phase III Trial in Kolkata, India
BACKGROUND: During the development of a vaccine, identification of the correlates of protection is of paramount importance for establishing an objective criterion for the protective performance of the vaccine. However, the ascertainment of correlates of immunity conferred by any vaccine is a difficu...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4011749/ https://www.ncbi.nlm.nih.gov/pubmed/24800828 http://dx.doi.org/10.1371/journal.pone.0096499 |
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author | Kanungo, Suman Lopez, Anna Lena Ali, Mohammad Manna, Byomkesh Kim, Deok Ryon Mahapatra, Tanmay Holmgren, Jan Dhingra, Mandeep S. Weirzba, Thomas F. Nair, G. Balakrish Bhattacharya, Sujit K. Clemens, John D. Sur, Dipika |
author_facet | Kanungo, Suman Lopez, Anna Lena Ali, Mohammad Manna, Byomkesh Kim, Deok Ryon Mahapatra, Tanmay Holmgren, Jan Dhingra, Mandeep S. Weirzba, Thomas F. Nair, G. Balakrish Bhattacharya, Sujit K. Clemens, John D. Sur, Dipika |
author_sort | Kanungo, Suman |
collection | PubMed |
description | BACKGROUND: During the development of a vaccine, identification of the correlates of protection is of paramount importance for establishing an objective criterion for the protective performance of the vaccine. However, the ascertainment of correlates of immunity conferred by any vaccine is a difficult task. METHODS: While conducting a phase three double-blind, cluster-randomized, placebo-controlled trial of a bivalent killed whole-cell oral cholera vaccine in Kolkata, we evaluated the immunogenicity of the vaccine in a subset of participants. Randomly chosen participants (recipients of vaccine or placebo) were invited to provide blood samples at baseline, 14 days after the second dose and one year after the first dose. At these time points, serum geometric mean titers (GMT) of vibriocidal antibodies and seroconversion rates for vaccine and placebo arms were calculated and compared across the age strata (1 to 5 years, 5 to 15 years and more than 15 years) as well as for all age groups. RESULTS: Out of 137 subjects included in analysis, 69 were vaccinees and 68 received placebo. There were 5•7 and 5•8 geometric mean fold (GMF) rises in titers to Vibrio cholerae Inaba and Ogawa, respectively at 14 days after the second dose, with 57% and 61% of vaccinees showing a four-fold or greater titer rise, respectively. After one year, the titers to Inaba and Ogawa remained 1•7 and 2•8 fold higher, respectively, compared to baseline. Serum vibriocidal antibody response to V. cholerae O139 was much lower than that to Inaba or Ogawa. No significant differences in the GMF-rises were observed among the age groups. CONCLUSIONS: The reformulated oral cholera vaccine induced a statistically significant anti-O1 Inaba and O1 Ogawa vibriocidal antibody response 14 days after vaccination, which although declined after one year remained significantly higher than baseline. Despite this decline, the vaccine remained protective five years after vaccination. |
format | Online Article Text |
id | pubmed-4011749 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-40117492014-05-09 Vibriocidal Antibody Responses to a Bivalent Killed Whole-Cell Oral Cholera Vaccine in a Phase III Trial in Kolkata, India Kanungo, Suman Lopez, Anna Lena Ali, Mohammad Manna, Byomkesh Kim, Deok Ryon Mahapatra, Tanmay Holmgren, Jan Dhingra, Mandeep S. Weirzba, Thomas F. Nair, G. Balakrish Bhattacharya, Sujit K. Clemens, John D. Sur, Dipika PLoS One Research Article BACKGROUND: During the development of a vaccine, identification of the correlates of protection is of paramount importance for establishing an objective criterion for the protective performance of the vaccine. However, the ascertainment of correlates of immunity conferred by any vaccine is a difficult task. METHODS: While conducting a phase three double-blind, cluster-randomized, placebo-controlled trial of a bivalent killed whole-cell oral cholera vaccine in Kolkata, we evaluated the immunogenicity of the vaccine in a subset of participants. Randomly chosen participants (recipients of vaccine or placebo) were invited to provide blood samples at baseline, 14 days after the second dose and one year after the first dose. At these time points, serum geometric mean titers (GMT) of vibriocidal antibodies and seroconversion rates for vaccine and placebo arms were calculated and compared across the age strata (1 to 5 years, 5 to 15 years and more than 15 years) as well as for all age groups. RESULTS: Out of 137 subjects included in analysis, 69 were vaccinees and 68 received placebo. There were 5•7 and 5•8 geometric mean fold (GMF) rises in titers to Vibrio cholerae Inaba and Ogawa, respectively at 14 days after the second dose, with 57% and 61% of vaccinees showing a four-fold or greater titer rise, respectively. After one year, the titers to Inaba and Ogawa remained 1•7 and 2•8 fold higher, respectively, compared to baseline. Serum vibriocidal antibody response to V. cholerae O139 was much lower than that to Inaba or Ogawa. No significant differences in the GMF-rises were observed among the age groups. CONCLUSIONS: The reformulated oral cholera vaccine induced a statistically significant anti-O1 Inaba and O1 Ogawa vibriocidal antibody response 14 days after vaccination, which although declined after one year remained significantly higher than baseline. Despite this decline, the vaccine remained protective five years after vaccination. Public Library of Science 2014-05-06 /pmc/articles/PMC4011749/ /pubmed/24800828 http://dx.doi.org/10.1371/journal.pone.0096499 Text en © 2014 Kanungo et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. |
spellingShingle | Research Article Kanungo, Suman Lopez, Anna Lena Ali, Mohammad Manna, Byomkesh Kim, Deok Ryon Mahapatra, Tanmay Holmgren, Jan Dhingra, Mandeep S. Weirzba, Thomas F. Nair, G. Balakrish Bhattacharya, Sujit K. Clemens, John D. Sur, Dipika Vibriocidal Antibody Responses to a Bivalent Killed Whole-Cell Oral Cholera Vaccine in a Phase III Trial in Kolkata, India |
title | Vibriocidal Antibody Responses to a Bivalent Killed Whole-Cell Oral Cholera Vaccine in a Phase III Trial in Kolkata, India |
title_full | Vibriocidal Antibody Responses to a Bivalent Killed Whole-Cell Oral Cholera Vaccine in a Phase III Trial in Kolkata, India |
title_fullStr | Vibriocidal Antibody Responses to a Bivalent Killed Whole-Cell Oral Cholera Vaccine in a Phase III Trial in Kolkata, India |
title_full_unstemmed | Vibriocidal Antibody Responses to a Bivalent Killed Whole-Cell Oral Cholera Vaccine in a Phase III Trial in Kolkata, India |
title_short | Vibriocidal Antibody Responses to a Bivalent Killed Whole-Cell Oral Cholera Vaccine in a Phase III Trial in Kolkata, India |
title_sort | vibriocidal antibody responses to a bivalent killed whole-cell oral cholera vaccine in a phase iii trial in kolkata, india |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4011749/ https://www.ncbi.nlm.nih.gov/pubmed/24800828 http://dx.doi.org/10.1371/journal.pone.0096499 |
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