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Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children
- Source :
- The Journal of Infectious Diseases. 226:299-307
- Publication Year :
- 2020
- Publisher :
- Oxford University Press (OUP), 2020.
-
Abstract
- 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.
- Subjects :
- 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
Subjects
Details
- ISSN :
- 15376613 and 00221899
- Volume :
- 226
- Database :
- OpenAIRE
- Journal :
- The Journal of Infectious Diseases
- Accession number :
- edsair.doi.dedup.....400aab6fcacef6df9fc6ee117e0d6db1