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An Age-stratified, Randomized Immunogenicity Trial of Killed Oral Cholera Vaccine with Delayed Second Dose in Cameroon
The recommended schedule for killed oral cholera vaccine (OCV) is two doses, 2 weeks apart. However, during vaccine campaigns, the second round is often delayed by several months. Because more information is needed to document antibody responses when the second dose is delayed, we conducted an open-...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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The American Society of Tropical Medicine and Hygiene
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9709001/ https://www.ncbi.nlm.nih.gov/pubmed/36395746 http://dx.doi.org/10.4269/ajtmh.22-0462 |
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author | Ateudjieu, Jérôme Sack, David A Nafack, Sonia Sonkeng Xiao, Shaoming Tchio-Nighie, Ketina Hirma Tchokomeni, Herve Bita’a, Landry Beyala Nyibio, Paul Ntsekendio Guenou, Etienne Mondung, Kedia Mayah Dieumo, Frank Forex Kiadjieu Ngome, Rosanne Minone Murt, Kelsey N. Ram, Malathi Ali, Mohammad Debes, Amanda K. |
author_facet | Ateudjieu, Jérôme Sack, David A Nafack, Sonia Sonkeng Xiao, Shaoming Tchio-Nighie, Ketina Hirma Tchokomeni, Herve Bita’a, Landry Beyala Nyibio, Paul Ntsekendio Guenou, Etienne Mondung, Kedia Mayah Dieumo, Frank Forex Kiadjieu Ngome, Rosanne Minone Murt, Kelsey N. Ram, Malathi Ali, Mohammad Debes, Amanda K. |
author_sort | Ateudjieu, Jérôme |
collection | PubMed |
description | The recommended schedule for killed oral cholera vaccine (OCV) is two doses, 2 weeks apart. However, during vaccine campaigns, the second round is often delayed by several months. Because more information is needed to document antibody responses when the second dose is delayed, we conducted an open-label, phase 2, noninferiority clinical trial of OCV. One hundred eighty-six participants were randomized into three dose-interval groups (DIGs) to receive the second dose 2 weeks, 6 months, or 11.5 months after the first dose. The DIGs were stratified into three age strata: 1 to 4, 5 to 14, and > 14 years. Inaba and Ogawa vibriocidal titers were assessed before and after vaccination. The primary analysis was geometric mean titer (GMT) 2 weeks after the second dose. Data for primary analysis was available from 147 participants (54, 44, and 49 participants from the three DIGs respectively). Relative to the 2-week interval, groups receiving a delayed second dose had significantly higher GMTs after the second dose. Two weeks after the second dose, Inaba GMTs were 55.1 190.3, and 289.8 and Ogawa GMTs were 70.4, 134.5, and 302.4 for the three DIGs respectively. The elevated titers were brief, returning to lower levels within 3 months. We conclude that when the second dose of killed oral cholera vaccine was given after 6 or 11.5 months, vibriocidal titers were higher than when given after the standard period of 2 weeks. This provides reassurance that a delayed second dose does not compromise, but rather enhances, the serological response to the vaccine. |
format | Online Article Text |
id | pubmed-9709001 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | The American Society of Tropical Medicine and Hygiene |
record_format | MEDLINE/PubMed |
spelling | pubmed-97090012022-11-30 An Age-stratified, Randomized Immunogenicity Trial of Killed Oral Cholera Vaccine with Delayed Second Dose in Cameroon Ateudjieu, Jérôme Sack, David A Nafack, Sonia Sonkeng Xiao, Shaoming Tchio-Nighie, Ketina Hirma Tchokomeni, Herve Bita’a, Landry Beyala Nyibio, Paul Ntsekendio Guenou, Etienne Mondung, Kedia Mayah Dieumo, Frank Forex Kiadjieu Ngome, Rosanne Minone Murt, Kelsey N. Ram, Malathi Ali, Mohammad Debes, Amanda K. Am J Trop Med Hyg Research Article The recommended schedule for killed oral cholera vaccine (OCV) is two doses, 2 weeks apart. However, during vaccine campaigns, the second round is often delayed by several months. Because more information is needed to document antibody responses when the second dose is delayed, we conducted an open-label, phase 2, noninferiority clinical trial of OCV. One hundred eighty-six participants were randomized into three dose-interval groups (DIGs) to receive the second dose 2 weeks, 6 months, or 11.5 months after the first dose. The DIGs were stratified into three age strata: 1 to 4, 5 to 14, and > 14 years. Inaba and Ogawa vibriocidal titers were assessed before and after vaccination. The primary analysis was geometric mean titer (GMT) 2 weeks after the second dose. Data for primary analysis was available from 147 participants (54, 44, and 49 participants from the three DIGs respectively). Relative to the 2-week interval, groups receiving a delayed second dose had significantly higher GMTs after the second dose. Two weeks after the second dose, Inaba GMTs were 55.1 190.3, and 289.8 and Ogawa GMTs were 70.4, 134.5, and 302.4 for the three DIGs respectively. The elevated titers were brief, returning to lower levels within 3 months. We conclude that when the second dose of killed oral cholera vaccine was given after 6 or 11.5 months, vibriocidal titers were higher than when given after the standard period of 2 weeks. This provides reassurance that a delayed second dose does not compromise, but rather enhances, the serological response to the vaccine. The American Society of Tropical Medicine and Hygiene 2022-11 2022-11-14 /pmc/articles/PMC9709001/ /pubmed/36395746 http://dx.doi.org/10.4269/ajtmh.22-0462 Text en © The author(s) https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution (CC-BY) License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Ateudjieu, Jérôme Sack, David A Nafack, Sonia Sonkeng Xiao, Shaoming Tchio-Nighie, Ketina Hirma Tchokomeni, Herve Bita’a, Landry Beyala Nyibio, Paul Ntsekendio Guenou, Etienne Mondung, Kedia Mayah Dieumo, Frank Forex Kiadjieu Ngome, Rosanne Minone Murt, Kelsey N. Ram, Malathi Ali, Mohammad Debes, Amanda K. An Age-stratified, Randomized Immunogenicity Trial of Killed Oral Cholera Vaccine with Delayed Second Dose in Cameroon |
title | An Age-stratified, Randomized Immunogenicity Trial of Killed Oral Cholera Vaccine with Delayed Second Dose in Cameroon |
title_full | An Age-stratified, Randomized Immunogenicity Trial of Killed Oral Cholera Vaccine with Delayed Second Dose in Cameroon |
title_fullStr | An Age-stratified, Randomized Immunogenicity Trial of Killed Oral Cholera Vaccine with Delayed Second Dose in Cameroon |
title_full_unstemmed | An Age-stratified, Randomized Immunogenicity Trial of Killed Oral Cholera Vaccine with Delayed Second Dose in Cameroon |
title_short | An Age-stratified, Randomized Immunogenicity Trial of Killed Oral Cholera Vaccine with Delayed Second Dose in Cameroon |
title_sort | age-stratified, randomized immunogenicity trial of killed oral cholera vaccine with delayed second dose in cameroon |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9709001/ https://www.ncbi.nlm.nih.gov/pubmed/36395746 http://dx.doi.org/10.4269/ajtmh.22-0462 |
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