Clinical trial
Neovac 2 Burkina Faso: Impact of the Integration of Hepatitis B Birth Dose Vaccine Into the Infant Immunization Schedule: a Mixed Methods Study Including a Cluster-randomized Trial, an Anthropological Study and an Economic Evaluation
Name
2017-083
Description
Hepatitis B virus (HBV) infection is an important global health problem, and the WHO adopted a strategy to eliminate HBV infection as a public health threat by the year 2030. In order to eliminate, it is critical to prevent the mother-to-child transmission (MTCT) of hepatitis B. Since 2009, the WHO recommends to administer hepatitis B vaccine within 24 hours of birth to prevent MTCT.2 However, in Africa, the majority of countries provide hepatitis B vaccine as a combined vaccine (pentavalent or hexavalent) at the age of 6-10-14 weeks or 8-12-16 weeks after the birth, and only 10 sub-Saharan African countries integrated birth dose vaccine into their national immunization program. This is because, the GAVI, the Vaccine Alliance, does not support monovalent hepatitis B vaccine, and also about half of babies in Africa are born at home without the immediate access to vaccination. Moreover, the evidence base to support this WHO's recommendation to start immunizing immediately at birth, rather than later at 6-8 weeks of life, is not strong.
Through a multidisciplinary approach comprising epidemiological, anthropological and economic components, the primary objective of the study is to measure the impact of the introduction of birth dose hepatitis B vaccine into the infant immunization program in Burkina Faso.
Expected results will be to develop strong evidence base (effectiveness \& cost-effectiveness) to recommend the integration of birth dose hepatitis B vaccine into the current vaccination schedule (8-12-16 weeks as a combined vaccine), to facilitate the Burkinabé Government to include the birth dose hepatitis B vaccine in their national vaccination program, to inform other African countries which have not yet integrated the birth dose hepatitis B vaccine in their national program and to imply whether additional strategy (e.g., maternal screening and antiviral therapy during pregnancy) might be necessary in order to eliminate the risk of mother-to-child transmission of hepatitis B.
Trial arms
Trial start
2020-10-19
Estimated PCD
2023-08-31
Trial end
2023-12-15
Status
Completed
Treatment
birth dose vaccination against hepatitis B strategy
Complex intervention targeting healthcare workers and involving:
* training on hepatitis B awareness and management
* training on EPI vaccination and cold chain
* training on the modalities for the birth dose administration
* the use of a monovalent unidose vaccine against Hepatitis B
Arms:
Intervention period
Size
10000
Primary endpoint
Proportion of positive HBV infection in 9-month-old children vaccinated at birth compared to children receiving their first vaccination at 8 weeks.
at 9 months old
Eligibility criteria
Inclusion Criteria:
* Pregnant woman
* Living in the study area
* Visited study health centre for the antenatal care or child delivery
* Provided a written informed consent
Exclusion Criteria:
* Miscarriage, abortion, stillborn, neonatal defect incompatible with life
* Any mother or child condition incompatible with the research activities
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Pragmatic Stepped-wedge cluster randomized trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10000, 'type': 'ACTUAL'}}
Updated at
2023-12-19
1 organization
1 product
1 indication
Organization
Institut PasteurIndication
Hepatitis B