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Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children
BACKGROUND: We conducted a trial in Nigeria to assess the immunogenicity of the new bivalent oral poliovirus vaccine + inactivated poliovirus vaccine (bOPV+IPV) immunization schedule and gains in type 2 immunity with addition of second dose of IPV. The trial was conducted in August 2016–March 2017,...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9189759/ https://www.ncbi.nlm.nih.gov/pubmed/33230550 http://dx.doi.org/10.1093/infdis/jiaa726 |
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author | Tagbo, Beckie N Verma, Harish Mahmud, Zubairu M Ernest, Kolade Nnani, Roosevelt O Chukwubike, Chinedu Craig, Kehinde T Hamisu, Abdullahi Weldon, William C Oberste, Steven M Jeyaseelan, Visalakshi Braka, Fiona Mkanda, Pascal Esangbedo, Dorothy Olowu, Adebiyi Nwaze, Eric Sutter, Roland W |
author_facet | Tagbo, Beckie N Verma, Harish Mahmud, Zubairu M Ernest, Kolade Nnani, Roosevelt O Chukwubike, Chinedu Craig, Kehinde T Hamisu, Abdullahi Weldon, William C Oberste, Steven M Jeyaseelan, Visalakshi Braka, Fiona Mkanda, Pascal Esangbedo, Dorothy Olowu, Adebiyi Nwaze, Eric Sutter, Roland W |
author_sort | Tagbo, Beckie N |
collection | PubMed |
description | BACKGROUND: We conducted a trial in Nigeria to assess the immunogenicity of the new bivalent oral poliovirus vaccine + inactivated poliovirus vaccine (bOPV+IPV) immunization schedule and gains in type 2 immunity with addition of second dose of IPV. The trial was conducted in August 2016–March 2017, well past the trivalent OPV-bOPV switch in April 2016. METHODS: This was an open-label, 2-arm, noninferiority, multicenter, randomized, controlled trial. We enrolled 572 infants aged ≤14 days and randomized them into 2 arms. Arm A received bOPV at birth, 6, and 10 weeks, bOPV+IPV at week 14, and IPV at week 18. Arm B received IPV each at 6, 10, and 14 weeks and bOPV at 18 weeks of age. RESULTS: Seroconversion rates for poliovirus types 1 and 3, respectively, were 98.9% (95% confidence interval [CI], 96.7–99.8) and 98.1% (95% CI, 88.2–94.8) in Arm A and 89.6% (95% CI, 85.4–93.0) and 98.5% (95% CI, 96.3–99.6) in Arm B. Type 2 seroconversion with 1 dose IPV in Arm A was 72.0% (95% CI, 66.2–77.3), which increased significantly with addition of second dose to 95.9% (95% CI, 92.8–97.9). CONCLUSIONS: This first trial on the new Expanded Program on Immunization (EPI) schedule in a sub-Saharan African country demonstrated excellent immunogenicity against poliovirus types 1 and 3 and substantial/enhanced immunogenicity against poliovirus type 2 after 1 to 2 doses of IPV, respectively. |
format | Online Article Text |
id | pubmed-9189759 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-91897592022-06-13 Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children Tagbo, Beckie N Verma, Harish Mahmud, Zubairu M Ernest, Kolade Nnani, Roosevelt O Chukwubike, Chinedu Craig, Kehinde T Hamisu, Abdullahi Weldon, William C Oberste, Steven M Jeyaseelan, Visalakshi Braka, Fiona Mkanda, Pascal Esangbedo, Dorothy Olowu, Adebiyi Nwaze, Eric Sutter, Roland W J Infect Dis Major Article BACKGROUND: We conducted a trial in Nigeria to assess the immunogenicity of the new bivalent oral poliovirus vaccine + inactivated poliovirus vaccine (bOPV+IPV) immunization schedule and gains in type 2 immunity with addition of second dose of IPV. The trial was conducted in August 2016–March 2017, well past the trivalent OPV-bOPV switch in April 2016. METHODS: This was an open-label, 2-arm, noninferiority, multicenter, randomized, controlled trial. We enrolled 572 infants aged ≤14 days and randomized them into 2 arms. Arm A received bOPV at birth, 6, and 10 weeks, bOPV+IPV at week 14, and IPV at week 18. Arm B received IPV each at 6, 10, and 14 weeks and bOPV at 18 weeks of age. RESULTS: Seroconversion rates for poliovirus types 1 and 3, respectively, were 98.9% (95% confidence interval [CI], 96.7–99.8) and 98.1% (95% CI, 88.2–94.8) in Arm A and 89.6% (95% CI, 85.4–93.0) and 98.5% (95% CI, 96.3–99.6) in Arm B. Type 2 seroconversion with 1 dose IPV in Arm A was 72.0% (95% CI, 66.2–77.3), which increased significantly with addition of second dose to 95.9% (95% CI, 92.8–97.9). CONCLUSIONS: This first trial on the new Expanded Program on Immunization (EPI) schedule in a sub-Saharan African country demonstrated excellent immunogenicity against poliovirus types 1 and 3 and substantial/enhanced immunogenicity against poliovirus type 2 after 1 to 2 doses of IPV, respectively. Oxford University Press 2020-11-24 /pmc/articles/PMC9189759/ /pubmed/33230550 http://dx.doi.org/10.1093/infdis/jiaa726 Text en © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Major Article Tagbo, Beckie N Verma, Harish Mahmud, Zubairu M Ernest, Kolade Nnani, Roosevelt O Chukwubike, Chinedu Craig, Kehinde T Hamisu, Abdullahi Weldon, William C Oberste, Steven M Jeyaseelan, Visalakshi Braka, Fiona Mkanda, Pascal Esangbedo, Dorothy Olowu, Adebiyi Nwaze, Eric Sutter, Roland W Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children |
title | Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children |
title_full | Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children |
title_fullStr | Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children |
title_full_unstemmed | Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children |
title_short | Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children |
title_sort | randomized controlled clinical trial of bivalent oral poliovirus vaccine and inactivated poliovirus vaccine in nigerian children |
topic | Major Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9189759/ https://www.ncbi.nlm.nih.gov/pubmed/33230550 http://dx.doi.org/10.1093/infdis/jiaa726 |
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