Evidence map›Paper›PMID 33230550›Full record

Trial reportThe Journal of infectious diseases2022

Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children.

Beckie N Tagbo, Harish Verma, Zubairu M Mahmud, Kolade Ernest, Roosevelt O Nnani, Chinedu Chukwubike, Kehinde T Craig, Abdullahi Hamisu, William C Weldon, Steven M Oberste and 7 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 8 institutions in 4 countries.

Beckie N TagboInstitute of Child Health/Department of Paediatrics, University of Nigeria Teaching Hospital, Enugu, Nigeria.ORCID 0000-0002-3590-2691
Harish VermaWorld Health Organization, Ave Appia, Geneva, Switzerland.
Zubairu M MahmudNational Primary Health Care Development Agency, Abuja, Nigeria.
Kolade ErnestDepartment of Pediatrics and Child Health, University of Ilorin Teaching Hospital, Ilorin, Nigeria.
Roosevelt O NnaniInstitute of Child Health, University of Nigeria Teaching Hospital, Enugu, Nigeria.
Chinedu ChukwubikeInstitute of Child Health, University of Nigeria Teaching Hospital, Enugu, Nigeria.
Kehinde T CraigWorld Health Organization, Abuja, Nigeria.
Abdullahi HamisuWorld Health Organization, Abuja, Nigeria.
William C WeldonCenters for Disease Control and Prevention, Atlanta, GA, USA.
Steven M ObersteCenters for Disease Control and Prevention, Atlanta, GA, USA.
Visalakshi JeyaseelanWorld Health Organization, Ave Appia, Geneva, Switzerland.
Fiona BrakaWorld Health Organization, Abuja, Nigeria.
Pascal MkandaWorld Health Organization, Regional Office for Africa, Brazzaville, Democratic Republic of the Congo.
Dorothy EsangbedoPediatrics Association of Nigeria, Abuja, Nigeria.
Adebiyi OlowuPediatrics Association of Nigeria, Abuja, Nigeria.
Eric NwazeNational Primary Health Care Development Agency, Abuja, Nigeria.
Roland W SutterWorld Health Organization, Ave Appia, Geneva, Switzerland.
University of Nigeria Teaching Hospital · NGWorld Health Organization · CHWorld Health Organization - Nigeria · NGCaritas Nigeria · NGCenters for Disease Control and Prevention · USNational Primary Health Care Development Agency · NGUniversity of Ilorin Teaching Hospital · NGWorld Health Organization Regional Office for Africa · CG

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundWe 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.

methodsThis 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.

resultsSeroconversion 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).

conclusionsThis 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.

Indexed as

PoliomyelitisPoliovirusAntibodies, ViralChildHumansImmunization ScheduleInfantInfant, NewbornNigeriaPoliovirus Vaccine, InactivatedPoliovirus Vaccine, OralVaccines, CombinedAntibodies, ViralPoliovirus Vaccine, InactivatedPoliovirus Vaccine, OralVaccines, CombinedchildrenNigeriapoliovirus vaccinerandomized controlled clinical trial

Identifiers

PMID33230550
PMCPMC9189759
OpenAlexW3106555696

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.