Hepatitis BNEOVAC2BKNCT04029454
Neovac 2 Burkina Faso: Impact of the Integration of Hepatitis B Birth Dose Vaccine Into the Infant Immunization Schedule
A study testing birth dose vaccination against hepatitis B strategy in people with Hepatitis B, run by Institut Pasteur at 2 sites in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- birth dose vaccination against hepatitis B strategy
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 2 sitesBurkina Faso
- Study dates
- 19 Oct 2020to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant woman
- Living in the study area
- Visited study health centre for the antenatal care or child delivery
- Provided a written informed consent
Who cannot join
- Miscarriage, abortion, stillborn, neonatal defect incompatible with life
- Any mother or child condition incompatible with the research activities
Trial locations and contacts
2 sites in 1 country.
Burkina Faso2 sites
District sanitaire de Dafra
Bobo-Dioulasso, Dafra
District sanitaire de Do
Bobo-Dioulasso, Do
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis B
- Being tested
- birth dose vaccination against hepatitis B strategy
- Keywords
- Infectious Disease Transmission, Vertical, immunization programs
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
birth dose vaccination against hepatitis B strategyBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention period | Experimental | 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 Receives: Biological: birth dose vaccination against hepatitis B strategy |
| Control period | No intervention | Routine Expended Programme on Imunisation (EPI) vaccination schedule starting at 8 weeks of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of positive HBV infection in 9-month-old children vaccinated at birth compared to children receiving their first vaccination at 8 weeks.
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.
Measured: at 9 months old
Secondary outcomes (2)
Prevalence rate of HBV infection in pregnancy from HBsAg and HBeAg profiles in mothers of 9-month-old children
Positive hepatitis B surface antigen (capillary blood obtained by finger-prick) and positive hepatitis B e surface antigen (blood sample).
Measured: at 9 months
Sensibility and specificity of low-cost alternative HBV markers
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
Measured: 9 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start19 Oct 2020
- Primary completion31 Aug 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pragmatic Stepped-wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Agence de Médecine Préventive, France, Centre Muraz, Institut National de la Santé Et de la Recherche Médicale, France, Gilead Sciences, Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029454
- Sponsor's protocol ID
- 2017-083
- Acronym
- NEOVAC2BK
- Status last verified
- Dec 2023
- First submitted
- 5 Jun 2019
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet. 2015 Oct 17;386(10003):1546-55. doi: 10.1016/S0140-6736(15)61412-X. Epub 2015 Jul 28.
PubMed 26231459MacLachlan JH, Cowie BC. Hepatitis B virus epidemiology. Cold Spring Harb Perspect Med. 2015 May 1;5(5):a021410. doi: 10.1101/cshperspect.a021410.
PubMed 25934461World Health Organization. Hepatitis B vaccines: WHO position paper, July 2017 - Recommendations. Vaccine. 2019 Jan 7;37(2):223-225. doi: 10.1016/j.vaccine.2017.07.046. Epub 2017 Jul 22.
PubMed 28743487Burk RD, Hwang LY, Ho GY, Shafritz DA, Beasley RP. Outcome of perinatal hepatitis B virus exposure is dependent on maternal virus load. J Infect Dis. 1994 Dec;170(6):1418-23. doi: 10.1093/infdis/170.6.1418.
PubMed 7995980Tamandjou CR, Maponga TG, Chotun N, Preiser W, Andersson MI. Is hepatitis B birth dose vaccine needed in Africa? Pan Afr Med J. 2017 Jun 22;27(Suppl 3):18. doi: 10.11604/pamj.supp.2017.27.3.11546. eCollection 2017.
PubMed 29296153Pan CQ, Zou HB, Chen Y, Zhang X, Zhang H, Li J, Duan Z. Cesarean section reduces perinatal transmission of hepatitis B virus infection from hepatitis B surface antigen-positive women to their infants. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1349-55. doi: 10.1016/j.cgh.2013.04.026. Epub 2013 Apr 29.
PubMed 23639606Edmunds WJ, Medley GF, Nokes DJ, O'Callaghan CJ, Whittle HC, Hall AJ. Epidemiological patterns of hepatitis B virus (HBV) in highly endemic areas. Epidemiol Infect. 1996 Oct;117(2):313-25. doi: 10.1017/s0950268800001497.
PubMed 8870629Barin F, Perrin J, Chotard J, Denis F, N'Doye R, Diop Mar I, Chiron JP, Coursaget P, Goudeau A, Maupas P. Cross-sectional and longitudinal epidemiology of hepatitis B in Senegal. Prog Med Virol. 1981;27:148-62. No abstract available.
PubMed 6972051Kiire CF. The epidemiology and prophylaxis of hepatitis B in sub-Saharan Africa: a view from tropical and subtropical Africa. Gut. 1996;38 Suppl 2(Suppl 2):S5-12. doi: 10.1136/gut.38.suppl_2.s5.
PubMed 8786055Edmunds WJ, Medley GF, Nokes DJ, Hall AJ, Whittle HC. The influence of age on the development of the hepatitis B carrier state. Proc Biol Sci. 1993 Aug 23;253(1337):197-201. doi: 10.1098/rspb.1993.0102.
PubMed 8397416Shimakawa Y, Yan HJ, Tsuchiya N, Bottomley C, Hall AJ. Association of early age at establishment of chronic hepatitis B infection with persistent viral replication, liver cirrhosis and hepatocellular carcinoma: a systematic review. PLoS One. 2013 Jul 19;8(7):e69430. doi: 10.1371/journal.pone.0069430. Print 2013.
PubMed 23894479Shimakawa 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.
PubMed 25728498Shimakawa 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.
PubMed 26185161Feldstein 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.
PubMed 29145357Kramvis 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.
PubMed 20673825
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04029454
- Acronym / sponsor ID
- NEOVAC2BK / 2017-083
- Conditions
- Hepatitis B
- Keywords
- Infectious Disease Transmission, Vertical, immunization programs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Agence de Médecine Préventive, France, Centre Muraz, Institut National de la Santé Et de la Recherche Médicale, France, Gilead Sciences, Abbott
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic Stepped-wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention period | Experimental | Biological: birth dose vaccination against hepatitis B strategyIntervention : 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 |
| Control period | No intervention | –Routine Expended Programme on Imunisation (EPI) vaccination schedule starting at 8 weeks of life |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pregnant woman
- Living in the study area
- Visited study health centre for the antenatal care or child delivery
- Provided a written informed consent
Key exclusion criteria (2 listed)
- Miscarriage, abortion, stillborn, neonatal defect incompatible with life
- Any mother or child condition incompatible with the research activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| birth dose vaccination against hepatitis B strategyComplex 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 | Biological | Intervention period |
Primary outcome
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.
2 secondary outcomes
Prevalence rate of HBV infection in pregnancy from HBsAg and HBeAg profiles in mothers of 9-month-old children
Time frame: at 9 months
Sensibility and specificity of low-cost alternative HBV markers
Time frame: 9 months after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Background: PubMed 26231459Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet. 2015 Oct 17;386(10003):1546-55. doi: 10.1016/S0140-6736(15)61412-X. Epub 2015 Jul 28.
- Background: PubMed 25934461MacLachlan JH, Cowie BC. Hepatitis B virus epidemiology. Cold Spring Harb Perspect Med. 2015 May 1;5(5):a021410. doi: 10.1101/cshperspect.a021410.
- Background: PubMed 28743487World Health Organization. Hepatitis B vaccines: WHO position paper, July 2017 - Recommendations. Vaccine. 2019 Jan 7;37(2):223-225. doi: 10.1016/j.vaccine.2017.07.046. Epub 2017 Jul 22.
- Background: PubMed 7995980Burk RD, Hwang LY, Ho GY, Shafritz DA, Beasley RP. Outcome of perinatal hepatitis B virus exposure is dependent on maternal virus load. J Infect Dis. 1994 Dec;170(6):1418-23. doi: 10.1093/infdis/170.6.1418.
- Background: PubMed 29296153Tamandjou CR, Maponga TG, Chotun N, Preiser W, Andersson MI. Is hepatitis B birth dose vaccine needed in Africa? Pan Afr Med J. 2017 Jun 22;27(Suppl 3):18. doi: 10.11604/pamj.supp.2017.27.3.11546. eCollection 2017.
- Background: PubMed 23639606Pan CQ, Zou HB, Chen Y, Zhang X, Zhang H, Li J, Duan Z. Cesarean section reduces perinatal transmission of hepatitis B virus infection from hepatitis B surface antigen-positive women to their infants. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1349-55. doi: 10.1016/j.cgh.2013.04.026. Epub 2013 Apr 29.
- Background: PubMed 8870629Edmunds WJ, Medley GF, Nokes DJ, O'Callaghan CJ, Whittle HC, Hall AJ. Epidemiological patterns of hepatitis B virus (HBV) in highly endemic areas. Epidemiol Infect. 1996 Oct;117(2):313-25. doi: 10.1017/s0950268800001497.
- Background: PubMed 6972051Barin F, Perrin J, Chotard J, Denis F, N'Doye R, Diop Mar I, Chiron JP, Coursaget P, Goudeau A, Maupas P. Cross-sectional and longitudinal epidemiology of hepatitis B in Senegal. Prog Med Virol. 1981;27:148-62. No abstract available.
- Background: PubMed 8786055Kiire CF. The epidemiology and prophylaxis of hepatitis B in sub-Saharan Africa: a view from tropical and subtropical Africa. Gut. 1996;38 Suppl 2(Suppl 2):S5-12. doi: 10.1136/gut.38.suppl_2.s5.
- Background: PubMed 8397416Edmunds WJ, Medley GF, Nokes DJ, Hall AJ, Whittle HC. The influence of age on the development of the hepatitis B carrier state. Proc Biol Sci. 1993 Aug 23;253(1337):197-201. doi: 10.1098/rspb.1993.0102.
- Background: PubMed 23894479Shimakawa Y, Yan HJ, Tsuchiya N, Bottomley C, Hall AJ. Association of early age at establishment of chronic hepatitis B infection with persistent viral replication, liver cirrhosis and hepatocellular carcinoma: a systematic review. PLoS One. 2013 Jul 19;8(7):e69430. doi: 10.1371/journal.pone.0069430. Print 2013.
- Background: PubMed 25728498Shimakawa 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.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing birth dose vaccination against hepatitis B strategy in people with Hepatitis B, run by Institut Pasteur at 2 sites in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04029454, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.