Immunogenicity of a Birth Dose of Hepatitis B Vaccine in Kinshasa, Democratic Republic of Congo: A Randomised, Controlled Trial.

Autor: Tulenko SE; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA., Ngimbi P; Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo., Mwandagalirwa K; Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo., Tabala M; Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo., Matondo J; Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo., Ntambua S; Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo., Mbonze N; Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo., Mbendi C; Department of Gastroenterology, University Hospital, Kinshasa, Democratic Republic of Congo., Luhata C; Expanded Programme on Immunisation, Kinshasa, Democratic Republic of Congo., Jhaveri R; Department of Pediatrics, Division of Infectious Diseases, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Edwards JK; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA., Becker-Dreps S; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.; Department of Family Medicine, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA., Moormann AM; Department of Medicine, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA., Kaba D; Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo., Yotebieng M; Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine, New York City, New York, USA., Parr JB; Division of Infectious Diseases, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA., Gower EW; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA., Thompson P; Division of Infectious Diseases, Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina, USA.
Jazyk: angličtina
Zdroj: Journal of viral hepatitis [J Viral Hepat] 2024 Dec; Vol. 31 (12), pp. 795-807. Date of Electronic Publication: 2024 Sep 24.
DOI: 10.1111/jvh.14003
Abstrakt: The WHO recommends hepatitis B birth-dose vaccination (HepB-BD), but it is not routinely given in most sub-Saharan African countries. We aimed to assess the immunogenicity of HepB-BD in addition to the existing hepatitis B vaccine (HepB3) schedule in Kinshasa, Democratic Republic of Congo among HBV-unexposed and HBV-exposed infants. Using an open-label, randomised, controlled design, HBV-unexposed infants were randomised (1:1) to receive the standard HepB3 vaccine series (group U3), or to receive HepB-BD in addition to HepB3 (group U4). A supplemental cohort of HBV-exposed infants (group E4) received HepB-BD and HepB3. We compared the proportion of infants with protective antibodies against HBV (HBV surface antibody ≥ 10 mIU/mL) between groups U3 and U4 and groups U4 and E4 at 12 months of age. Between August 20 and October 9, 2019, we enrolled 281 mother/infant dyads; 88 (31.3%) returned at 12 months. Most infants had protective antibodies against HBV at 12 months: 92.9% (75.7%-98.2%) in group U3, 85.7% (67.5%-94.5%) in group U4 and 96.9% (95% CI: 81.2%-99.6%) in group E4. Trends held in estimates adjusted for loss-to-follow-up (LTFU) and baseline imbalance across groups. In this first randomised trial assessing the addition of HepB-BD to the hepatitis B vaccine schedule in SSA, we found that HBV-unexposed infants who received the 3-dose and 4-dose vaccine series had similar immunogenicity against HBV at 12 months. A high proportion of infants, and notably HBV-exposed infants, had protective antibodies. Though extrapolation of findings may be limited by LTFU, this study adds real-world evidence regarding HepB-BD implementation in sub-Saharan Africa. Trial Registration: ClinicalTrials.gov identifier: NCT03897946.
(© 2024 John Wiley & Sons Ltd.)
Databáze: MEDLINE
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