Clinical trial NCT04029454 - References

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

Citation(s)

•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   Janzen J
  The Social Fabric of Health: An Introduction to Medical Anthropology. McGraw-Hill; 2002.
•   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.
•   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.
•   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.
•   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.
•   MacLachlan JH, Cowie BC
  Hepatitis B virus epidemiology. Cold Spring Harb Perspect Med. 2015 May 1;5(5):a021410. doi: 10.1101/cshperspect.a021410.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   Winkelman M
  Culture and Health: Applying Medical Anthropology. Jossey-Bass. 2008.
•   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.

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

Details for clinical trial NCT04029454