drugset / Trial / NCT03897946
Evaluating Immunogenicity of a Birth Dose of HBV Vaccine in the DRC
Phase 4
Completed
569 enrolled
University of North Carolina, Chapel Hill
Burroughs Wellcome · collabThe American Society of Tropical Medicine and Hygiene · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This project will assess the immunogenicity of a birth dose of hepatitis B vaccine in hepatitis B-exposed and hepatitis B-unexposed infants in Kinshasa, Democratic Republic of the Congo. A better understanding of the protection offered by the addition of birth dose vaccine to the EPI schedule is necessary in order to promote universal adoption of a birth dose vaccine in the DRC and throughout SSA.
Timeline
- Start
- 2019-08-20
- Primary completion
- 2021-02-05
- Completion
- 2021-02-05
Publications
- Background O'Hara GA, McNaughton AL, Maponga T, Jooste P, Ocama P, Chilengi R, Mokaya J, Liyayi MI, Wachira T, Gikungi DM, Burbridge L, O'Donnell D, Akiror CS, Sloan D, Torimiro J, Yindom LM, Walton R, Andersson M, Marsh K, Newton R, Matthews PC. Hepatitis B virus infection as a neglected tropical disease. PLoS Negl Trop Dis. 2017 Oct 5;11(10):e0005842. doi: 10.1371/journal.pntd.0005842. eCollection 2017 Oct. No abstract available.
- Background 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.
- Background Keane E, Funk AL, Shimakawa Y. Systematic review with meta-analysis: the risk of mother-to-child transmission of hepatitis B virus infection in sub-Saharan Africa. Aliment Pharmacol Ther. 2016 Nov;44(10):1005-1017. doi: 10.1111/apt.13795. Epub 2016 Sep 15.
- 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.
- Background Breakwell L, Tevi-Benissan C, Childs L, Mihigo R, Tohme R. The status of hepatitis B control in the African region. Pan Afr Med J. 2017 Jun 22;27(Suppl 3):17. doi: 10.11604/pamj.supp.2017.27.3.11981. eCollection 2017.
- Background Wilson P, Parr JB, Jhaveri R, Meshnick SR. Call to Action: Prevention of Mother-to-Child Transmission of Hepatitis B in Africa. J Infect Dis. 2018 Mar 28;217(8):1180-1183. doi: 10.1093/infdis/jiy028.
- Background Andersson MI, Rajbhandari R, Kew MC, Vento S, Preiser W, Hoepelman AI, Theron G, Cotton M, Cohn J, Glebe D, Lesi O, Thursz M, Peters M, Chung R, Wiysonge C. Mother-to-child transmission of hepatitis B virus in sub-Saharan Africa: time to act. Lancet Glob Health. 2015 Jul;3(7):e358-9. doi: 10.1016/S2214-109X(15)00056-X. No abstract available.
- Background Klingler C, Thoumi AI, Mrithinjayam VS. Cost-effectiveness analysis of an additional birth dose of Hepatitis B vaccine to prevent perinatal transmission in a medical setting in Mozambique. Vaccine. 2012 Dec 17;31(1):252-9. doi: 10.1016/j.vaccine.2012.08.007. Epub 2012 Aug 15.
- Background Poovorawan Y, Sanpavat S, Pongpunlert W, Chumdermpadetsuk S, Sentrakul P, Safary A. Protective efficacy of a recombinant DNA hepatitis B vaccine in neonates of HBe antigen-positive mothers. JAMA. 1989 Jun 9;261(22):3278-81.
- Background Wong VC, Ip HM, Reesink HW, Lelie PN, Reerink-Brongers EE, Yeung CY, Ma HK. Prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis-B vaccine and hepatitis-B immunoglobulin. Double-blind randomised placebo-controlled study. Lancet. 1984 Apr 28;1(8383):921-6. doi: 10.1016/s0140-6736(84)92388-2.
- Background Tsega E, Tafesse B, Nordenfelt E, Wolde-Hawariat G, Hansson BG, Lindberg J. Immunogenicity of hepatitis B vaccine simultaneously administered with the expanded programme on immunisation (EPI). J Med Virol. 1990 Dec;32(4):232-5. doi: 10.1002/jmv.1890320407.
- Background Apiung T, Ndanu TA, Mingle JA, Sagoe KW. Hepatitis B virus surface antigen and antibody markers in children at a major paediatric hospital after the pentavalent DTP-HBV-Hib vaccination. Ghana Med J. 2017 Mar;51(1):13-19. doi: 10.4314/gmj.v51i1.3.
- Background Abu-Raya B, Kollmann TR, Marchant A, MacGillivray DM. The Immune System of HIV-Exposed Uninfected Infants. Front Immunol. 2016 Sep 28;7:383. doi: 10.3389/fimmu.2016.00383. eCollection 2016.
- Background Njom Nlend AE, Nguwoh PS, Ngounouh CT, Tchidjou HK, Pieme CA, Otele JM, Penlap V, Colizzi V, Moyou RS, Fokam J. HIV-Infected or -Exposed Children Exhibit Lower Immunogenicity to Hepatitis B Vaccine in Yaounde, Cameroon: An Appeal for Revised Policies in Tropical Settings? PLoS One. 2016 Sep 22;11(9):e0161714. doi: 10.1371/journal.pone.0161714. eCollection 2016.
- Tulenko SE, Ngimbi P, Mwandagalirwa K, Tabala M, Matondo J, Ntambua S, Mbonze N, Mbendi C, Luhata C, Jhaveri R, Edwards JK, Becker-Dreps S, Moormann AM, Kaba D, Yotebieng M, Parr JB, Gower EW, Thompson P. Immunogenicity of a Birth Dose of Hepatitis B Vaccine in Kinshasa, Democratic Republic of Congo: A Randomised, Controlled Trial. J Viral Hepat. 2024 Dec;31(12):795-807. doi: 10.1111/jvh.14003. Epub 2024 Sep 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Birth dose hepatitis B vaccine | Vaccine | — | — |