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An open-label, randomized efficacy and safety trial of subcutaneous and intramuscular BT088 (Fovepta) human hepatitis B immunoglobulin in neonates of HBV-carrier mothers
-
Horst Buxmann
,
Wolfgang Kamin
Published/Copyright:
February 1, 2012
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.
Conclusion: 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.
Keywords: BT088; Fovepta; HBsAg; hepatitis B infection; hepatitis B virus; human hepatitis B virus immunoglobulin; neonates
Received: 2011-8-4
Revised: 2011-12-17
Accepted: 2012-1-2
Published Online: 2012-02-01
Published in Print: 2012-06-01
©2012 by Walter de Gruyter Berlin Boston
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Keywords for this article
BT088;
Fovepta;
HBsAg;
hepatitis B infection;
hepatitis B virus;
human hepatitis B virus immunoglobulin;
neonates
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- Masthead
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