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- Title
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).
- Authors
Tall, Haoua; Adam, Pierrick; Tiendrebeogo, Abdoul Salam Eric; Vincent, Jeanne Perpétue; Schaeffer, Laura; von Platen, Cassandre; Fernandes-Pellerin, Sandrine; Sawadogo, François; Bokoum, Alkadri; Bouda, Ghislain; Ouattara, Seydou; Ouédraogo, Issa; Herrant, Magali; Boucheron, Pauline; Sawadogo, Appolinaire; Betsem, Edouard; Essoh, Alima; Kabore, Lassané; Ouattara, Amariane; Méda, Nicolas
- Abstract
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.
- Subjects
SUB-Saharan Africa; BURKINA Faso; CLUSTER randomized controlled trials; IMMUNIZATION of children; HEPATITIS B; HEPATITIS associated antigen; INFANTS; RESEARCH protocols; HEPATITIS B vaccines
- Publication
Vaccines, 2021, Vol 9, Issue 6, p583
- ISSN
2076-393X
- Publication type
Article
- DOI
10.3390/vaccines9060583