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Oral Polio Vaccine (OPV) to Mitigate the Risk of Illness and Mortality During the COVID-19 Pandemic: A Cluster-Randomised Trial in Guinea-Bissau

22 Pages Posted: 21 Jun 2022

See all articles by Ane Fisker

Ane Fisker

Bandim Health Project, INDEPTH Network

Justiniano S. D. Martins

Statens Serums Institut - Bandim Health Project

Line M. Pedersen

Statens Serums Institut - Bandim Health Project

Andreas M. Jensen

University of Southern Denmark - Department of Clinical Research; Statens Serums Institut - Bandim Health Project

Elsi J. C. Ca

Statens Serums Institut - Bandim Health Project

Sebastian Nielsen

Statens Serums Institut - Bandim Health Project

Cesario Martins

Bandim Health Project, INDEPTH Network

Amabelia Rodrigues

Bandim Health Project, INDEPTH Network

More...

Abstract

Background: Oral Polio Vaccine (OPV) may strengthen the immune system broadly improving resistance to non-polio-infections. Prior to COVID-19 vaccines being widely available, we tested if OPV could reduce the risk of illness and mortality.

Methods: We conducted an unblinded cluster-randomised trial. Houses in urban Guinea-Bissau were randomised 1:1 to intervention or control. Residents aged 50+ years were invited to participate. Participants received bivalent OPV (single dose) or nothing and were followed for 6 months. Rates of mortality, admissions, and consultation for infections (primary composite outcome) were compared in Cox proportional hazards models adjusted for age and area of residence. Secondary outcomes included mortality, admissions, consultations, and symptoms of infection.

Findings: Among 3729 enrolled participants, we followed 3726 (OPV: 1580; Control: 2146) and registered 66 deaths, 97 admissions and 298 consultations for infections. OPV did not reduce the risk of the composite outcome, hazard ratio (HR)=0.97 (95%CI: 0.79-1.18). The effect differed by sex (HR=0.71 (0.51-0.98) for men; HR=1.18 (0.91-1.52) for women; p for same effect=0.02) and by BCG scar-status (HR=0.70 (0.49-0.99) in scar-positive; HR=1.13 (0.89-1.45) in scar-negative participants; p=0.03). OPV had no overall significant effect on mortality (HR=0.96 (0.59-1.55)), admissions (HR=0.76 (0.49-1.17)) or recorded consultations (HR=0.99 (0.79-1.25)). Only 2/590 participants with reported COVID-19 test stated positive results. OPV was associated with increased reporting of symptoms of infection (6050 episodes; HR=1.10 (1.03-1.17)).

Interpretation: OPV increased reported symptoms of infections but did not increase the risk of severe infections. OPV appeared to benefit men and BCG-scar positive participants.

Trial Registration: Registration: www.clinicaltrials.gov/NCT04445428

Funding: University of Southern Denmark supported the trial. ABF was supported by an Ascending investigator grant from Lundbeck Foundation (R313-2019-635) and a Sapere Aude grant from Independent Research Fund Denmark (9060-00018B).

Declaration of Interest: The authors have no conflicts of interest.

Ethical Approval: The trial was approved by the Comité Nacional de Ética na Saúde, Guinea-Bissau on 21 May 2020 (Ref: 077/CNES/INASA/2020) and received consultative approval from The National Committee on Health Research Ethics, Denmark on 16 June 2020 (Ref: 2008258).

Keywords: Oral Polio Vaccine, Non-specific (heterologous) effects of vaccine, mortality, morbidity

Suggested Citation

Fisker, Ane and Martins, Justiniano S. D. and Pedersen, Line M. and Jensen, Andreas M. and Ca, Elsi J. C. and Nielsen, Sebastian and Martins, Cesario and Rodrigues, Amabelia, Oral Polio Vaccine (OPV) to Mitigate the Risk of Illness and Mortality During the COVID-19 Pandemic: A Cluster-Randomised Trial in Guinea-Bissau. Available at SSRN: https://ssrn.com/abstract=4141345 or http://dx.doi.org/10.2139/ssrn.4141345

Ane Fisker (Contact Author)

Bandim Health Project, INDEPTH Network

Justiniano S. D. Martins

Statens Serums Institut - Bandim Health Project ( email )

Denmark

Line M. Pedersen

Statens Serums Institut - Bandim Health Project

Denmark

Andreas M. Jensen

University of Southern Denmark - Department of Clinical Research ( email )

Denmark

Statens Serums Institut - Bandim Health Project ( email )

Denmark

Elsi J. C. Ca

Statens Serums Institut - Bandim Health Project ( email )

Denmark

Sebastian Nielsen

Statens Serums Institut - Bandim Health Project ( email )

Cesario Martins

Bandim Health Project, INDEPTH Network

Amabelia Rodrigues

Bandim Health Project, INDEPTH Network