Neovac 2 Burkina Faso: Impact of the Integration of Hepatitis B Birth Dose Vaccine Into the Infant Immunization Schedule (NEOVAC2BK)
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|ClinicalTrials.gov Identifier: NCT04029454|
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : November 30, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B||Biological: birth dose vaccination against hepatitis B strategy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8500 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Pragmatic Stepped-wedge cluster randomized trial|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 19, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Intervention period
Intervention : birth dose vaccination against hepatitis B strategy Birth dose of vaccine against hepatitis B + routine Expended Programme on Imunisation (EPI) vaccination schedule starting at 8 weeks of life
Biological: birth dose vaccination against hepatitis B strategy
Complex intervention targeting healthcare workers and involving:
No Intervention: Control period
Routine Expended Programme on Imunisation (EPI) vaccination schedule starting at 8 weeks of life
- Proportion of positive HBV infection in 9-month-old children vaccinated at birth compared to children receiving their first vaccination at 8 weeks. [ Time Frame: at 9 months old ]Capillary blood obtained by finger-prick will be used for a rapid diagnostic test for HBsAg detection in order to identify positive hepatitis B surface antigen (HBsAg) in infants and their mother then compare immunological responses by study arm (children who received the birth dose versus those who did not receive it) on titration of anti-HBs antibodies.
- Prevalence rate of HBV infection in pregnancy from HBsAg and HBeAg profiles in mothers of 9-month-old children [ Time Frame: at 9 months ]Positive hepatitis B surface antigen (capillary blood obtained by finger-prick) and positive hepatitis B e surface antigen (blood sample).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029454
|Contact: Haoua TALL, PharmD, MPH||+226 771 703 firstname.lastname@example.org|
|Contact: Kania Dramane, PharmD, PHD||+226 20 97 01 email@example.com|
|District sanitaire de Dafra||Recruiting|
|Bobo-Dioulasso, Dafra, Burkina Faso|
|Contact: Alkadri BOKOUM, MD +226 62 63 73 37 mailto:firstname.lastname@example.org|
|District sanitaire de Do||Recruiting|
|Bobo-Dioulasso, Do, Burkina Faso|
|Contact: Ghislain BOUDA, MD +226 71 81 74 40 mailto:email@example.com|