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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,...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
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.
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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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