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

NCT04029454 | Completed

• 1 other identifier: 2017-083
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis B

Keywords

Infectious Disease Transmission, Vertical; immunization programs

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  at 9 months

• Sensibility and specificity of low-cost alternative HBV markers

  9 months after delivery

Study Arms (2)

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

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

Interventions

birth dose vaccination against hepatitis B strategy BIOLOGICAL

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

Intervention period

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant woman
• Living in the study area
• Visited study health centre for the antenatal care or child delivery
• Provided a written informed consent

You may not qualify if:

• Miscarriage, abortion, stillborn, neonatal defect incompatible with life
• Any mother or child condition incompatible with the research activities

Sponsors & Collaborators

• Institut Pasteur: lead
• Agence de Médecine Préventive, France: collaborator
• Centre Muraz: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Gilead Sciences: collaborator
• Abbott: collaborator

Study Sites (2)

District sanitaire de Dafra

Bobo-Dioulasso, Dafra, Burkina Faso

Location

District sanitaire de Do

Bobo-Dioulasso, Do, Burkina Faso

Location

Related Publications (41)

• 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.

  PMID: 26231459 BACKGROUND

• MacLachlan JH, Cowie BC. Hepatitis B virus epidemiology. Cold Spring Harb Perspect Med. 2015 May 1;5(5):a021410. doi: 10.1101/cshperspect.a021410.

  PMID: 25934461 BACKGROUND

• World 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.

  PMID: 28743487 BACKGROUND

• Burk 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.

  PMID: 7995980 BACKGROUND

• Tamandjou 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.

  PMID: 29296153 BACKGROUND

• Pan 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.

  PMID: 23639606 BACKGROUND

• Edmunds 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.

  PMID: 8870629 BACKGROUND

• Barin 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.

  PMID: 6972051 BACKGROUND

• Kiire 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.

  PMID: 8786055 BACKGROUND

• Edmunds 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.

  PMID: 8397416 BACKGROUND

• Shimakawa 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.

  PMID: 23894479 BACKGROUND

• 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.

  PMID: 25728498 BACKGROUND

• 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.

  PMID: 26185161 BACKGROUND

• 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.

  PMID: 29145357 BACKGROUND

• 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.

  PMID: 20673825 BACKGROUND

• 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.

  PMID: 16625613 BACKGROUND

• 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.

  PMID: 18436354 BACKGROUND

• 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.

  PMID: 7942775 BACKGROUND

• Pan CQ, Duan Z, Dai E, Zhang S, Han G, Wang Y, Zhang H, Zou H, Zhu B, Zhao W, Jiang H; China Study Group for the Mother-to-Child Transmission of Hepatitis B. Tenofovir to Prevent Hepatitis B Transmission in Mothers with High Viral Load. N Engl J Med. 2016 Jun 16;374(24):2324-34. doi: 10.1056/NEJMoa1508660.

  PMID: 27305192 BACKGROUND

• Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.

  PMID: 25662947 BACKGROUND

• Copas AJ, Lewis JJ, Thompson JA, Davey C, Baio G, Hargreaves JR. Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Trials. 2015 Aug 17;16:352. doi: 10.1186/s13063-015-0842-7.

  PMID: 26279154 BACKGROUND

• Baio G, Copas A, Ambler G, Hargreaves J, Beard E, Omar RZ. Sample size calculation for a stepped wedge trial. Trials. 2015 Aug 17;16:354. doi: 10.1186/s13063-015-0840-9.

  PMID: 26282553 BACKGROUND

• Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.

  PMID: 16829207 BACKGROUND

• 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.

  PMID: 26344808 BACKGROUND

• van den Ende C, Marano C, van Ahee A, Bunge EM, De Moerlooze L. The immunogenicity of GSK's recombinant hepatitis B vaccine in children: a systematic review of 30 years of experience. Expert Rev Vaccines. 2017 Aug;16(8):789-809. doi: 10.1080/14760584.2017.1338569. Epub 2017 Jul 3.

  PMID: 28586278 BACKGROUND

• Jourdain G, Ngo-Giang-Huong N, Harrison L, Decker L, Khamduang W, Tierney C, Salvadori N, Cressey TR, Sirirungsi W, Achalapong J, Yuthavisuthi P, Kanjanavikai P, Na Ayudhaya OP, Siriwachirachai T, Prommas S, Sabsanong P, Limtrakul A, Varadisai S, Putiyanun C, Suriyachai P, Liampongsabuddhi P, Sangsawang S, Matanasarawut W, Buranabanjasatean S, Puernngooluerm P, Bowonwatanuwong C, Puthanakit T, Klinbuayaem V, Thongsawat S, Thanprasertsuk S, Siberry GK, Watts DH, Chakhtoura N, Murphy TV, Nelson NP, Chung RT, Pol S, Chotivanich N. Tenofovir versus Placebo to Prevent Perinatal Transmission of Hepatitis B. N Engl J Med. 2018 Mar 8;378(10):911-923. doi: 10.1056/NEJMoa1708131.

  PMID: 29514030 BACKGROUND

• 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.

  PMID: 16555290 BACKGROUND

• Hyams KC. Risks of chronicity following acute hepatitis B virus infection: a review. Clin Infect Dis. 1995 Apr;20(4):992-1000. doi: 10.1093/clinids/20.4.992.

  PMID: 7795104 BACKGROUND

• Njai HF, Shimakawa Y, Sanneh B, Ferguson L, Ndow G, Mendy M, Sow A, Lo G, Toure-Kane C, Tanaka J, Taal M, D'alessandro U, Njie R, Thursz M, Lemoine M. Validation of rapid point-of-care (POC) tests for detection of hepatitis B surface antigen in field and laboratory settings in the Gambia, Western Africa. J Clin Microbiol. 2015 Apr;53(4):1156-63. doi: 10.1128/JCM.02980-14. Epub 2015 Jan 28.

  PMID: 25631805 BACKGROUND

• Riou J, Ait Ahmed M, Blake A, Vozlinsky S, Brichler S, Eholie S, Boelle PY, Fontanet A; HCV epidemiology in Africa group. Hepatitis C virus seroprevalence in adults in Africa: a systematic review and meta-analysis. J Viral Hepat. 2016 Apr;23(4):244-55. doi: 10.1111/jvh.12481. Epub 2015 Oct 19.

  PMID: 26477881 BACKGROUND

• Vray M, Debonne JM, Sire JM, Tran N, Chevalier B, Plantier JC, Fall F, Vernet G, Simon F, Mb PS. Molecular epidemiology of hepatitis B virus in Dakar, Senegal. J Med Virol. 2006 Mar;78(3):329-34. doi: 10.1002/jmv.20544.

  PMID: 16419106 BACKGROUND

• Lemoine M, Shimakawa Y, Njie R, Taal M, Ndow G, Chemin I, Ghosh S, Njai HF, Jeng A, Sow A, Toure-Kane C, Mboup S, Suso P, Tamba S, Jatta A, Sarr L, Kambi A, Stanger W, Nayagam S, Howell J, Mpabanzi L, Nyan O, Corrah T, Whittle H, Taylor-Robinson SD, D'Alessandro U, Mendy M, Thursz MR; PROLIFICA investigators. Acceptability and feasibility of a screen-and-treat programme for hepatitis B virus infection in The Gambia: the Prevention of Liver Fibrosis and Cancer in Africa (PROLIFICA) study. Lancet Glob Health. 2016 Aug;4(8):e559-67. doi: 10.1016/S2214-109X(16)30130-9.

  PMID: 27443781 BACKGROUND

• Duffy D, Mottez E, Ainsworth S, Buivan TP, Baudin A, Vray M, Reed B, Fontanet A, Rohel A, Petrov-Sanchez V, Abel L, Theodorou I, Miele G, Pol S, Albert ML. An in vitro diagnostic certified point of care single nucleotide test for IL28B polymorphisms. PLoS One. 2017 Sep 6;12(9):e0183084. doi: 10.1371/journal.pone.0183084. eCollection 2017.

  PMID: 28877177 BACKGROUND

• Posuwan N, Payungporn S, Tangkijvanich P, Ogawa S, Murakami S, Iijima S, Matsuura K, Shinkai N, Watanabe T, Poovorawan Y, Tanaka Y. Genetic association of human leukocyte antigens with chronicity or resolution of hepatitis B infection in thai population. PLoS One. 2014 Jan 23;9(1):e86007. doi: 10.1371/journal.pone.0086007. eCollection 2014.

  PMID: 24465836 BACKGROUND

• Demolis R, Botao C, Heyerdahl LW, Gessner BD, Cavailler P, Sinai C, Magaco A, Le Gargasson JB, Mengel M, Guillermet E. A rapid qualitative assessment of oral cholera vaccine anticipated acceptability in a context of resistance towards cholera intervention in Nampula, Mozambique. Vaccine. 2018 Oct 22;36(44):6497-6505. doi: 10.1016/j.vaccine.2017.10.087. Epub 2017 Nov 27.

  PMID: 29174106 BACKGROUND

• Janzen J. The Social Fabric of Health: An Introduction to Medical Anthropology. McGraw-Hill; 2002.

  BACKGROUND

• Winkelman M. Culture and Health: Applying Medical Anthropology. Jossey-Bass. 2008.

  BACKGROUND

• Giles-Vernick T, Traore A, Bainilago L. Incertitude, Hepatitis B, and Infant Vaccination in West and Central Africa. Med Anthropol Q. 2016 Jun;30(2):203-21. doi: 10.1111/maq.12187. Epub 2016 Mar 31.

  PMID: 25624042 BACKGROUND

• Scott S, Odutola A, Mackenzie G, Fulford T, Afolabi MO, Lowe Jallow Y, Jasseh M, Jeffries D, Dondeh BL, Howie SR, D'Alessandro U. Coverage and timing of children's vaccination: an evaluation of the expanded programme on immunisation in The Gambia. PLoS One. 2014 Sep 18;9(9):e107280. doi: 10.1371/journal.pone.0107280. eCollection 2014.

  PMID: 25232830 BACKGROUND

• Briggs AH, Goeree R, Blackhouse G, O'Brien BJ. Probabilistic analysis of cost-effectiveness models: choosing between treatment strategies for gastroesophageal reflux disease. Med Decis Making. 2002 Jul-Aug;22(4):290-308. doi: 10.1177/0272989X0202200408.

  PMID: 12150595 BACKGROUND

• 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.

  PMID: 34206058 DERIVED

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pragmatic Stepped-wedge cluster randomized trial

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: July 23, 2019
• Study Start: October 19, 2020
• Primary Completion: August 31, 2023
• Study Completion: December 15, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BU (2)