Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children
| Autor: | William C. Weldon, Adebiyi Olowu, Beckie N. Tagbo, Pascal Mkanda, Harish Verma, Visalakshi Jeyaseelan, Kehinde Craig, Roland W. Sutter, Eric Nwaze, Steven M. Oberste, Dorothy O Esangbedo, Kolade Ernest, Roosevelt O Nnani, Chinedu M. Chukwubike, Fiona Braka, Zubairu M Mahmud, Abdullahi Walla Hamisu |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty 030106 microbiology Nigeria Antibodies Viral medicine.disease_cause law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine parasitic diseases medicine Humans Immunology and Allergy Vaccines Combined 030212 general & internal medicine Seroconversion Child Poliovirus type Immunization Schedule business.industry Immunogenicity Poliovirus Infant Newborn Infant Oral Poliovirus Vaccine Clinical trial Poliovirus Vaccine Inactivated Infectious Diseases Poliovirus Vaccine Oral Inactivated Poliovirus Vaccine business Poliomyelitis |
| Zdroj: | The Journal of Infectious Diseases. 226:299-307 |
| ISSN: | 1537-6613 0022-1899 |
| DOI: | 10.1093/infdis/jiaa726 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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