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, 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

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.

Keywords: birth dose vaccination; complex intervention; hepatitis B vaccine; implementation science; mixed method; mother-to-child transmission; stepped wedge cluster randomized trial; sub-Saharan Africa.

Conflict of interest statement

All authors report no competing interest.

Figures

Figure 1
Figure 1
Schematic representation of the stepped wedge design (24 clusters with an interval of 3 weeks per step).
Figure 2
Figure 2
Study area (rural zones of Dô and Dafra districts in Hauts-Bassins Region). Adapted from Plan d’action sanitaire de Dô et Dafra [28,29].
Figure 3
Figure 3
Participant timeline.
Figure 4
Figure 4
Algorithm for participants tested positive for HBsAg.
Figure 5
Figure 5
Power of the study according to the number of infants evaluated at the age of 9 months per cluster and per period.

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