| Autor: |
Tall H; Epidémiologie des Maladies Evitables par la Vaccination, Agence de Médecine Préventive (AMP), Ouagadougou BP 638, Burkina Faso., Adam P; Unité d'Epidémiologie des Maladies Emergentes, Institut Pasteur, 75015 Paris, France., Tiendrebeogo ASE; Epidémiologie des Maladies Evitables par la Vaccination, Agence de Médecine Préventive (AMP), Ouagadougou BP 638, Burkina Faso., Vincent JP; Unité d'Epidémiologie des Maladies Emergentes, Institut Pasteur, 75015 Paris, France., Schaeffer L; Unité d'Epidémiologie des Maladies Emergentes, Institut Pasteur, 75015 Paris, France., von Platen C; Centre de Recherche Translationnelle, Institut Pasteur, 75015 Paris, France., Fernandes-Pellerin S; Centre de Recherche Translationnelle, Institut Pasteur, 75015 Paris, France., Sawadogo F; Epidémiologie des Maladies Evitables par la Vaccination, Agence de Médecine Préventive (AMP), Ouagadougou BP 638, Burkina Faso., Bokoum A; District Sanitaire de Dafra, Ministry of Health, Bobo-Dioulasso BP 1508, Burkina Faso., Bouda G; District Sanitaire de Dô, Ministry of Health, Bobo-Dioulasso BP 1508, Burkina Faso., Ouattara S; Direction Régionale de la Santé des Hauts-Bassins, Ministry of Health, Bobo-Dioulasso BP 1508, Burkina Faso., Ouédraogo I; Direction de la Prévention par les Vaccinations (DPV), Ministry of Health, Ouagadougou BP 7009, Burkina Faso., Herrant M; Direction Internationale, Institut Pasteur, 75015 Paris, France., Boucheron P; Unité d'Epidémiologie des Maladies Emergentes, Institut Pasteur, 75015 Paris, France., Sawadogo A; Département de Médicine, CHU Souro Sanou, Bobo-Dioulasso BP 676, Burkina Faso., Betsem E; Epidémiologie des Maladies Evitables par la Vaccination, Agence de Médecine Préventive (AMP), Ouagadougou BP 638, Burkina Faso., Essoh A; Epidémiologie des Maladies Evitables par la Vaccination, Agence de Médecine Préventive (AMP), Ouagadougou BP 638, Burkina Faso., Kabore L; Epidémiologie des Maladies Evitables par la Vaccination, Agence de Médecine Préventive (AMP), Ouagadougou BP 638, Burkina Faso., Ouattara A; Laboratoire de Virologie, Centre Muraz, Bobo-Dioulasso BP 390, Burkina Faso., Méda N; Laboratoire de Virologie, Centre Muraz, Bobo-Dioulasso BP 390, Burkina Faso., Hien H; Laboratoire de Virologie, Centre Muraz, Bobo-Dioulasso BP 390, Burkina Faso., Gosset A; Sciences Economiques & Sociales de La Santé & Traitement de l'Information Médicale (SESSTIM), INSERM, IRD, Aix-Marseille University, 13385 Marseille, France., Giles-Vernick T; Unité d'Anthropologie et Ecologie de l'Emergence des Maladies, Institut Pasteur, 75015 Paris, France., Boyer S; Sciences Economiques & Sociales de La Santé & Traitement de l'Information Médicale (SESSTIM), INSERM, IRD, Aix-Marseille University, 13385 Marseille, France., Kania D; Laboratoire de Virologie, Centre Muraz, Bobo-Dioulasso BP 390, Burkina Faso., Vray M; Unité d'Epidémiologie des Maladies Emergentes, Institut Pasteur, 75015 Paris, France.; INSERM, 75013 Paris, France., Shimakawa Y; Unité d'Epidémiologie des Maladies Emergentes, Institut Pasteur, 75015 Paris, France. |
| Abstrakt: |
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. |
