Efficacy of Birth Dose Vaccination in Preventing Mother-to-Child Transmission of Hepatitis B: A Randomized Controlled Trial Comparing Engerix-B and Sci-B-Vac

Abstract

Background and aims: Peripartum transmission of hepatitis B virus (HBV) from an infected mother to the child can be prevented in most but not all cases by immediate vaccination of the newborn. The aim of this study was to compare the efficacy of two licensed hepatitis B vaccines, Engerix-B versus Sci-B-Vac, in preventing peripartum HBV transmission. Methods: A prospective multicenter randomized controlled study in 4 delivery centers was performed from 2009 to 2014. HBsAg positive pregnant women and their newborns were recruited at the delivery rooms. All newborns received Hepatitis B Immune Globulin within 10 h after birth, as well as active HBV vaccination at 0, 1 and 6 months of age. Maternal assessment at delivery included transaminases, blood count, international normalized ratio and viral status. Infants were tested for HBsAg, anti-HBc and anti-HBs at 12 months of age. Results: In the intention to treat (ITT), 171 infant and mother pairs fulfilled the study enrollment criteria and completed follow up, 82 received Engerix-B and 89 Sci-B-Vac. Maternal parameters and viral status were similar in both groups. At 12 months of age, the Sci-B-Vac group had lower HBsAg carriage rates (1/89, 1.1%) than the Engerix-B group (5/82, 6.1%) with borderline significance (risk difference of −0.05, 95% CI −0.11–0.007, t-test = 0.05), and borderline significance lower vaccine failure rates with anti-HBs < 10 mIU/mL in the Sci-B-Vac (2/89, 2.2%) than in the Engerix-B (8/82, 9.8%, p = 0.05). Higher seroprotection rates were found in the Sci-B-Vac group with all anti-HBs titer stratifications of >10 mIU/mL (p = 0.05), >100 mIU/mL (p = 0.05) and >1000 mIU/mL (p = 0.01). Active/passive vaccination was effective in 10/13 cases with maternal HBV DNA levels > 7 log10 IU/mL up to 9.5 log10 IU/mL, but failed in 3 cases for unknown reasons. Conclusion: Sci-B-Vac was superior to Engerix-B in preventing peripartum HBV transmission in neonates from HBsAg+ mothers and induces significantly higher anti-HBs levels. NIH registration number: NCT 01133184.

Insights into induction of the immune response by the hepatitis B vaccine

“…These data making turn Sci-B-Vac of particular interest for its use in people with poor or no response. Particularly, Sci-B-Vac has shown greater efficacy in HIV-infected individuals’ immunization and in the prevention of vertical infection transmission[ 122 , 123 ]. Furthermore, the multiple antigen display of the third-generation vaccines would protect against HBV vaccine breakthrough infections caused by the HBV S gene mutants widely described[ 124 - 126 ].…”

Hepatitis-B-Impfstoffe – Geschichte, Erfolge, Herausforderungen und Perspektiven

“…Pasteur (n.v.) 2 HBsAg-Proteine (S, M) ayw [ 28 ] 1996 Sci-B-Vac®, VBI Vaccines (z.) a 3 HBsAg-Proteine (S, M, L) adw [ 35 , 36 ] 2001 Hepagene®, Medeva (n.v.) 3 HBsAg-Proteine (S, M, L) adw und ayw [ 2 , 37 ] Neue Konzepte 2016 BM32®, Viravaxx (exp.) PräS-Graspollenallergen Fusionsprotein [ 38 , 39 ] Al.…”

“…In einem großen multizentrischen Feldversuch mit 1607 Teilnehmern wurde erneut die Überlegenheit von Sci-B-Vac® gegenüber Engerix-B®, speziell bei älteren Probanden belegt [ 35 ]. Vielleicht noch wichtiger für die Eradikation des HBV ist eine kleine Studie aus Israel an Neugeborenen von HBV-infizierten Müttern [ 36 ]. Nach Impfung mit Sci-B-Vac® und HBIG waren nur ein von 89 Kindern nach einem Jahr HBsAg-positiv, dagegen 5 von 82 nach Engerix-B® plus HBIG ( p = 0,05).…”

The remarkable success of the vaccine for a killer virus: Hepatitis B

“…[ 10] Additionally, a randomized controlled trial in Israel comparing standard‐of‐care HBV vaccine (i.e., Engerix‐B) to a three‐antigen HBV vaccine (Sci‐B‐Vac) showed greater efficacy in prevention of mother‐to‐child transmission and higher HBV surface antibody titers at 1 year. [ 11] Further studies with novel vaccine formulations are needed in the general pediatric subpopulation in regard to long‐term antibody response and immunity, but may be a future alternative for improved neonatal HBV vaccine programs.…”