title: An open-label, randomized efficacy and safety trial of subcutaneous and intramuscular BT088 (Fovepta) human hepatitis B immunoglobulin in neonates of HBV-carrier mothers.
abstract: OBJECTIVE
  The objective of the study was to assess the efficacy and safety of subcutaneously (SC) and intramuscularly (IM) administered BT088 (Fovepta) human hepatitis B immunoglobulin in neonates of hepatitis B surface antigen (HBs/HBsAg)-positive mothers in the prevention of hepatitis B infection.
  
  
  METHODS
  This was an open, prospective, multicenter trial, in which infants were randomized to receive a single SC or IM dose of BT088 (200 IU, 0.4 mL) within 12 h of birth simultaneously with active vaccination against hepatitis B. The primary efficacy variable was the response rate, defined as the proportion of infants whose anti-HBs concentration was negative at predose and ≥100 IU/L 48 to 72 h postdose.
  
  
  RESULTS
  The full analysis set included 31 neonates (17 SC and 14 IM). Response was experienced by 30 (96.8%) of 31 infants who received BT088 by either route of administration. The median postdose anti-HBs concentration was 261.2 IU/L. One neonate had a postdose anti-HBs level lower than 100 IU/L (81.0 IU/L). No infant experienced seroconversion during the 7- to 15-month follow-up. BT088 was well tolerated, with no allergic-like, or injection-site reactions observed.
  
  
  CONCLUSIONS
  SC and IM administration of 200 IU (0.4 mL) BT088 resulted in protective serum anti-HBs titers within 72 h of administration in newborn infants and was well tolerated and effective.
authors: Department of Pediatric Medicine, Neonatology, Johann-Wolfgang Goethe University, Theodor Stern Kai 7, Frankfurt, Germany. horst.buxmann@kgu.de
authors: Horst
authors: H
authors: Buxmann
authors: Wolfgang
authors: W
authors: Kamin
authors: Gergely
authors: G
authors: Kriván
authors: Pál
authors: P
authors: Siklós
authors: Werner
authors: W
authors: Mendling
authors: Andrea
authors: A
authors: Wartenberg-Demand
authors: Daniele M
authors: DM
authors: Wolf
authors: Rolf L
authors: RL
authors: Schlösser
mesh_terms: D002353:Carrier State; D005260:Female; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control* / Q000635:transmission; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage* / Q000009:adverse effects; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000821:virology; D011446:Prospective Studies; D014611:Vaccination
chemical_list: C559911:BT088 immunoglobulin, human; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D007136:Immunoglobulins