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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
Sponsor:
Collaborators:
Agence de Médecine Préventive, France
Centre Muraz
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Institut Pasteur

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8500 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Pragmatic Stepped-wedge cluster randomized trial
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


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
Biological: 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

No Intervention: Control period
Routine Expended Programme on Imunisation (EPI) vaccination schedule starting at 8 weeks of life



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Haoua TALL, PharmD, MPH +226 771 703 66 htall@aamp.org
Contact: Kania Dramane, PharmD, PHD +226 20 97 01 02 diebakane@gmail.com

Locations
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Burkina Faso
District sanitaire de Dafra Recruiting
Bobo-Dioulasso, Dafra, Burkina Faso
Contact: Alkadri BOKOUM, MD    +226 62 63 73 37    mailto:alkadria1@yahoo.fr   
District sanitaire de Do Recruiting
Bobo-Dioulasso, Do, Burkina Faso
Contact: Ghislain BOUDA, MD    +226 71 81 74 40    mailto:ghislainbouda@yahoo.com   
Sponsors and Collaborators
Institut Pasteur
Agence de Médecine Préventive, France
Centre Muraz
Institut National de la Santé Et de la Recherche Médicale, France
Additional Information:
Publications:
Janzen J. The Social Fabric of Health: An Introduction to Medical Anthropology. McGraw-Hill; 2002.
Winkelman M. Culture and Health: Applying Medical Anthropology. Jossey-Bass. 2008.

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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT04029454    
Other Study ID Numbers: 2017-083
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Pasteur:
Infectious Disease Transmission, Vertical
immunization programs
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs