- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04029454
Neovac 2 Burkina Faso: Impact of the Integration of Hepatitis B Birth Dose Vaccine Into the Infant Immunization Schedule (NEOVAC2BK)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study combines mixed methods to achieve its aim of evaluating the impact of the introduction of birth dose hepatitis B vaccine into the infant immunisation program in Burkina Faso. It is composed of 4 components:
Workpackage (WP1): Stepped Wedge Cluster randomized controlled trial:
- to measure the impact of the introduction of birth dose hepatitis B vaccine into the infant immunization program on the mother-to-child transmission (primary objective)
- To examine a dose-dependent effect of hepatitis B vaccine (according to the total number of doses from one to four doses)
- To examine a time-dependent effect of the first dose of hepatitis B vaccine
- To study the impact of birth dose vaccine in infants aged at 9 months according to maternal HBsAg and HBeAg status
- To compare immunological responses in both groups by titration of anti-HBs antibodies in children at 9 months
- To describe vaccine coverage and its timeliness of birth dose hepatitis B vaccine and other routine infant vaccines in Burkina Faso
- To estimate the prevalence of HBV infection in mothers of 9-month-old children
WP2: Anthropological study • To evaluate the acceptability of healthcare workers and people in the community about the integration of hepatitis B birth dose vaccine in the infant vaccination program in Burkina Faso
WP3: Economic evaluation
- To evaluate the cost-effectiveness of the integration of hepatitis B birth dose vaccine in the infant vaccination program, compared to the conventional vaccine schedule (8-12-16 weeks) in Burkina Faso
- To evaluate the diagnostic performance of low-cost HBV markers to identify women at high risk of mother-to-child transmission in low-income countries
WP4: Virological evaluation
• To evaluate the diagnostic performance of low-cost HBV markers to identify women at high risk of mother-to-child transmission in low-income countries
All the pregnant women attending the antenatal care in the rural health centres of two health districts (Dafra and Dô) in Hauts Bassins Region in Burkina Faso, and their infants will be asked to participate.
Practical sequence of the cluster randomised trial. Even though the evidence is weak and the implementation has been suboptimal, the WHO currently recommends the universal administration of hepatitis B vaccine at birth. For this reason, a "stepped-wedge" design rather than a parallel group design has been selected. Of 24 rural health centers (Centre de santé et de promotion sociale : CSPS) in the districts of Dafra and Dô, introduce monovalent birth dose vaccine will be introduced in a phased manner on a centre by centre basis until all the 24 CSPSs integrate the birth dose vaccines in the program. The rural area of these districts were selected given the proximity to our collaborative study center (Centre Muraz and AMP in Bobo Dioulasso). One of the 24 centers will be randomly selected as the first one to start integrating the birth dose in the program. Then, four weeks later, the second center will be randomly selected to start providing the birth dose vaccine. This will be continued until all 24 CSPSs integrate birth dose vaccine in the program. At the end, this study design will generate two groups of infants in the study area during the study period: those born in centres which already implemented birth dose vaccine, and those born before the introduction of this vaccine.
Informed consent will be obtained from pregnant women who visited routine antenatal care. Subsequently, babies born in a CSPS which is in the intervention period will receive birth dose vaccine whilst those born in a CSPS which is in the control period will not receive the birth dose. For those born at home in the intervention period will receive the monovalent hepatitis B vaccine at the first contact with CSPS, until 8 weeks after the birth when the first dose of pentavalent vaccine (DPT-Hib-HepB) is scheduled. All the infants, irrespective of study period, will receive three doses of pentavalent vaccine as scheduled in the national immunization program.
Case report forms will be used (CRFs to collect basic demographic data of mothers and infants; time and place of birth; type of vaccines administered and its date Laboratory data: HBsAg for all infants and mothers; HBV DNA, HBeAg, AST/ALT for infants and mothers tested positive for HBsAg; anti-HBs for infants tested negative for HBsAg Paper CRFs filled by healthcare workers will be transferred to the study centre (AMP/Centre Muraz). The data will be entered independently by two operators to electronic database (RedCAP) that will be developed on the secured server of the Institut Pasteur.
The risk of HBV infection (HBsAg-positivity) in infants at the age of 9 months between two groups will be compared using an intention-to-treat analysis, in order to assess the effectiveness of adding birth dose vaccine compared to the current vaccine schedule in preventing the mother-to-child transmission in Burkina Faso. To adjust for the calendar time and clustering in the data, A logistic regression model will fit with random effect for cluster and fixed effect for each step.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Haoua TALL, PharmD, MPH
- Phone Number: +226 771 703 66
- Email: htall@aamp.org
Study Contact Backup
- Name: Kania Dramane, PharmD, PHD
- Phone Number: +226 20 97 01 02
- Email: diebakane@gmail.com
Study Locations
-
-
Dafra
-
Bobo-Dioulasso, Dafra, Burkina Faso
- District sanitaire de Dafra
-
-
Do
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Bobo-Dioulasso, Do, Burkina Faso
- District sanitaire de Do
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at 9 months old
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
at 9 months
|
Sensibility and specificity of low-cost alternative HBV markers
Time Frame: 9 months after delivery
|
qHBsAg, qHBeAg, RDT HBeAg, HBcrAg, and HBV LAMP results obtained with sera samples of HBsAg positive women will be compared to qPCR results as reference.
Their performance (sensibility and specificity) to identify women at high risk of mother-to-child transmission (≥200 000 IU/mL) will then be calculated
|
9 months after delivery
|
Collaborators and Investigators
Publications and helpful links
General Publications
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- Shimakawa Y, Lemoine M, Bottomley C, Njai HF, Ndow G, Jatta A, Tamba S, Bojang L, Taal M, Nyan O, D'Alessandro U, Njie R, Thursz M, Hall AJ. Birth order and risk of hepatocellular carcinoma in chronic carriers of hepatitis B virus: a case-control study in The Gambia. Liver Int. 2015 Oct;35(10):2318-26. doi: 10.1111/liv.12814. Epub 2015 Mar 11.
- Shimakawa Y, Lemoine M, Njai HF, Bottomley C, Ndow G, Goldin RD, Jatta A, Jeng-Barry A, Wegmuller R, Moore SE, Baldeh I, Taal M, D'Alessandro U, Whittle H, Njie R, Thursz M, Mendy M. Natural history of chronic HBV infection in West Africa: a longitudinal population-based study from The Gambia. Gut. 2016 Dec;65(12):2007-2016. doi: 10.1136/gutjnl-2015-309892. Epub 2015 Jul 16.
- Feldstein LR, Mariat S, Gacic-Dobo M, Diallo MS, Conklin LM, Wallace AS. Global Routine Vaccination Coverage, 2016. MMWR Morb Mortal Wkly Rep. 2017 Nov 17;66(45):1252-1255. doi: 10.15585/mmwr.mm6645a3.
- Kramvis A, Clements CJ. Implementing a birth dose of hepatitis B vaccine for home deliveries in Africa--too soon? Vaccine. 2010 Sep 7;28(39):6408-10. doi: 10.1016/j.vaccine.2010.07.042. Epub 2010 Jul 29.
- Lee C, Gong Y, Brok J, Boxall EH, Gluud C. Hepatitis B immunisation for newborn infants of hepatitis B surface antigen-positive mothers. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004790. doi: 10.1002/14651858.CD004790.pub2.
- Ekra D, Herbinger KH, Konate S, Leblond A, Fretz C, Cilote V, Douai C, Da Silva A, Gessner BD, Chauvin P. A non-randomized vaccine effectiveness trial of accelerated infant hepatitis B immunization schedules with a first dose at birth or age 6 weeks in Cote d'Ivoire. Vaccine. 2008 May 23;26(22):2753-61. doi: 10.1016/j.vaccine.2008.03.018. Epub 2008 Mar 31.
- Marion SA, Tomm Pastore M, Pi DW, Mathias RG. Long-term follow-up of hepatitis B vaccine in infants of carrier mothers. Am J Epidemiol. 1994 Oct 15;140(8):734-46. doi: 10.1093/oxfordjournals.aje.a117321.
- Hemming K, Taljaard M. Sample size calculations for stepped wedge and cluster randomised trials: a unified approach. J Clin Epidemiol. 2016 Jan;69:137-46. doi: 10.1016/j.jclinepi.2015.08.015. Epub 2015 Sep 5.
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- Collenberg E, Ouedraogo T, Ganame J, Fickenscher H, Kynast-Wolf G, Becher H, Kouyate B, Krausslich HG, Sangare L, Tebit DM. Seroprevalence of six different viruses among pregnant women and blood donors in rural and urban Burkina Faso: A comparative analysis. J Med Virol. 2006 May;78(5):683-92. doi: 10.1002/jmv.20593.
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Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-083
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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