Neovac 2 Burkina Faso: Impact of the Integration of Hepatitis B Birth Dose Vaccine Into the Infant Immunization Schedule (NEOVAC2BK)

• ClinicalTrials.gov Identifier: NCT04029454
• Recruitment Status: Recruiting
• First Posted: July 23, 2019
• Last Update Posted: April 20, 2022
• Sponsor: Institut Pasteur
• Collaborators: Agence de Médecine Préventive, France; Centre Muraz; Institut National de la Santé Et de la Recherche Médicale, France; Gilead Sciences; Abbott
• Information provided by (Responsible Party): Institut Pasteur

Study Description

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

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 Design

• 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: March 31, 2023
• Estimated Study Completion Date: March 31, 2023

Arms and Interventions

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

Outcome Measures

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).
2. 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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Burkina Faso

District sanitaire de Dafra; Recruiting

Bobo-Dioulasso, Dafra, Burkina Faso

Contact: Désiré CONGO, MD +22670754411 mailto:congodesire@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

Gilead Sciences

Abbott

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tall H, Adam P, Tiendrebeogo ASE, Vincent JP, Schaeffer L, von Platen C, Fernandes-Pellerin S, Sawadogo F, Bokoum A, Bouda G, Ouattara S, Ouedraogo I, Herrant M, Boucheron P, Sawadogo A, Betsem E, Essoh A, Kabore L, Ouattara A, Meda N, Hien H, Gosset A, Giles-Vernick T, Boyer S, Kania D, Vray M, Shimakawa Y. Impact of Introducing Hepatitis B Birth Dose Vaccines into the Infant Immunization Program in Burkina Faso: Study Protocol for a Stepped Wedge Cluster Randomized Trial (NeoVac Study). Vaccines (Basel). 2021 Jun 1;9(6):583. doi: 10.3390/vaccines9060583.

• Responsible Party: Institut Pasteur
• ClinicalTrials.gov Identifier: NCT04029454
• Other Study ID Numbers: 2017-083
• First Posted: July 23, 2019
• Last Update Posted: April 20, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Hepatitis A; Hepatitis B; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections