Vaccines (Jun 2021)

Impact of Introducing Hepatitis B Birth Dose Vaccines into the Infant Immunization Program in Burkina Faso: Study Protocol for a Stepped Wedge Cluster Randomized Trial (NéoVac Study)

  • Haoua Tall,
  • Pierrick Adam,
  • Abdoul Salam Eric Tiendrebeogo,
  • Jeanne Perpétue Vincent,
  • Laura Schaeffer,
  • Cassandre von Platen,
  • Sandrine Fernandes-Pellerin,
  • François Sawadogo,
  • Alkadri Bokoum,
  • Ghislain Bouda,
  • Seydou Ouattara,
  • Issa Ouédraogo,
  • Magali Herrant,
  • Pauline Boucheron,
  • Appolinaire Sawadogo,
  • Edouard Betsem,
  • Alima Essoh,
  • Lassané Kabore,
  • Amariane Ouattara,
  • Nicolas Méda,
  • Hervé Hien,
  • Andréa Gosset,
  • Tamara Giles-Vernick,
  • Sylvie Boyer,
  • Dramane Kania,
  • Muriel Vray,
  • Yusuke Shimakawa

DOI
https://doi.org/10.3390/vaccines9060583
Journal volume & issue
Vol. 9, no. 6
p. 583

Abstract

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To achieve global hepatitis elimination by 2030, it is critical to prevent the mother-to-child transmission (MTCT) of hepatitis B virus (HBV). Since 2009, the WHO has recommended administering hepatitis B vaccine to all neonates within 24 h of birth to prevent MTCT. However, many countries in sub-Saharan Africa only provide hepatitis B immunization at the age of 6, 10, and 14 weeks or 8, 12, and 16 weeks using a combined vaccine. To accelerate the introduction of the hepatitis B birth dose vaccine (HepB-BD) into sub-Saharan Africa, it is critical to establish to what extent the addition of HepB-BD can further reduce HBV transmission in areas where three-dose infant vaccination has been implemented. We therefore designed a study to evaluate the impact, acceptability, and cost-effectiveness of incorporating the HepB-BD into the routine immunization program in a real-life field condition in Burkina Faso, where the hepatitis B vaccination is currently scheduled at 8-12-16 weeks. Through a multidisciplinary approach combining epidemiology, anthropology, and health economics, the Neonatal Vaccination against Hepatitis B in Africa (NéoVac) study conducts a pragmatic stepped wedge cluster randomized controlled trial in rural areas of the Hauts-Bassins Region. The study was registered in ClinicalTrials.gov (identifier: NCT04029454). A health center is designated as a cluster, and the introduction of HepB-BD will be rolled out sequentially in 24 centers. Following an initial period in which no health center administers HepB-BD, one center will be randomly allocated to incorporate HepB-BD. Then, at a regular interval, another center will be randomized to cross from the control to the intervention period, until all 24 centers integrate HepB-BD. Pregnant women attending antenatal care will be systematically invited to participate. Infants born during the control period will follow the conventional immunization schedule (8-12-16 weeks), while those born in the interventional period will receive HepB-BD in addition to the routine vaccines (0-8-12-16 weeks). The primary outcome, the proportion of hepatitis B surface antigen (HBsAg) positivity in infants aged at 9 months, will be compared between children born before and after HepB-BD introduction. The study will generate data that may assist governments and stakeholders in sub-Saharan Africa to make evidence-based decisions about whether to add HepB-BD into the national immunization programs.

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