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Can earlier BCG vaccination reduce early infant mortality? Study protocol for a cluster randomised trial in Guinea-Bissau
  1. Sanne M Thysen1,2,3,
  2. Aksel Karl Georg Jensen4,
  3. Amabelia Rodrigues3,
  4. Igualdino da Silva Borges3,
  5. Peter Aaby2,3,
  6. Christine Benn1,2,3,
  7. Ane Fisker1,2,3
  1. 1 OPEN, University of Southern Denmark, Odense, Denmark
  2. 2 Research Center of Vitamins and Vaccines, Statens Serum Institut, Copenhagen S, Denmark
  3. 3 Bandim Health Project, Bandim Health Project, Bissau, Guinea-Bissau
  4. 4 Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark
  1. Correspondence to Dr Sanne M Thysen; s.thysen{at}bandim.org

Abstract

Introduction The BCG vaccine is designed to protect against tuberculosis, but the vaccine may have broader effects. In 2014, the Strategic Advisory Group of Experts on Immunization reviewed the literature on non-specific effects of BCG, and concluded that the evidence was consistent with beneficial non-specific effects and requested further randomised trials.

Methods and analyses Within the Bandim Health Project’s urban and rural health and demographic surveillance systems, we will conduct a cluster-randomised trial in six suburban districts and 55 rural villages. Infants are enrolled at a home visit before 72 hours of life. In intervention clusters, children are vaccinated with BCG and oral polio vaccine (OPV). In control clusters, the caregivers are informed about vaccination opportunities. Using Cox-proportional hazards models, we will test whether BCG and OPV provided at a single home visit can reduce early infant mortality up to 60 days.

The trial was initiated with a pilot study in Biombo region in June 2015. The trial was scaled up to full study including Oio and Cacheu regions in July 2016. The trial was expanded to include the urban study area in July 2017.

Ethics and dissemination BCG vaccination is delayed in many low-income settings. WHO-recommended home visits are resource demanding and vaccines are not part of the recommendation. Utilising the home visits to provide BCG and OPV may provide countries with a further incentive to introduce a single home visit. In countries, where home visits are already in place, vaccines can easily be added to reduce early infant mortality. The trial is approved by the Guinean Ethical Committee (Reference number: 0016/CNES/INASA/2015) and the Danish Ethics Committee has given its consultative approval. The results of the trial will be published in international peer-reviewed journals.

Trial registration number NCT02504203; Pre-results.

  • BCG vaccine
  • Oral polio vaccine
  • Cluster randomised trial
  • Non-specific effects of vaccines

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors AR, PA and CB conceived the idea for the trial. SMT, PA, CB and AF designed the study. SMT set up the study with help from ABF. SMT, IdSB and AF supervised data collection. SMT, AKGJ, and AF planned the data analyses. SMT drafted the manuscript and data analysis plan with help from AKGJ and AF. All authors read and approved the final manuscript and data analysis plan.

  • Funding Karen Elise Jensen Foundation is the main funder of the trial. Laerdal Foundation supports the trial. The Research Center for Vitamins and Vaccines, Bandim Health Project receives support from the Danish National Research Foundation (DNRF108). The funders had no role in the design of the study or writing of the protocol.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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