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) - Archive ouverte HAL Access content directly
Journal Articles Vaccines Year : 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)

(1) , (2) , (1) , (2) , (2) , (3) , (3) , (1) , (4) , (4) , (4) , (4) , (5) , (2) , (6) , (1) , (1) , (1) , (7) , (7) , (7) , (8) , (9) , (8) , (7) , (2) , (2)
1
2
3
4
5
6
7
8
9
Haoua Tall
  • Function : Author
  • PersonId : 1119281
Ghislain Bouda
  • Function : Author
  • PersonId : 1119284
Magali Herrant
  • Function : Author
  • PersonId : 1119285
Nicolas Méda
  • Function : Author
  • PersonId : 982781
Hervé Hien
  • Function : Author
  • PersonId : 1119287

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.
Fichier principal
Vignette du fichier
vaccines-09-00583-v2.pdf (3.3 Mo) Télécharger le fichier
Origin : Publisher files allowed on an open archive

Dates and versions

inserm-03465179 , version 1 (03-12-2021)

Identifiers

Cite

Haoua Tall, Pierrick Adam, Abdoul Salam Eric Tiendrebeogo, Jeanne Perpétue Vincent, Laura Schaeffer, et al.. 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). Vaccines, 2021, 9 (6), pp.583. ⟨10.3390/vaccines9060583⟩. ⟨inserm-03465179⟩
174 View
58 Download

Altmetric

Share

Gmail Facebook Twitter LinkedIn More