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Journal of Perinatal Medicine

Official Journal of the World Association of Perinatal Medicine

Editor-in-Chief: Dudenhausen, Joachim W.

Editorial Board Member: / Bancalari, Eduardo / Milner, Anne / Genc, Mehmet R. / Chervenak, Frank A. / Chappelle, Joseph / Bergmann, Renate L. / Bernardes, J.F. / Bevilacqua, G. / Blickstein, Isaac / Cabero Roura, Luis / Carbonell-Estrany, Xavier / Carrera, Jose M. / D`Addario, Vincenzo / D'Alton, MD, Mary E. / Dimitrou, G. / Grunebaum, Amos / Hentschel, Roland / Köpcke, W. / Kawabata, Ichiro / Keirse, Marc J.N.C. / Kurjak M.D., Asim / Lee, Ben H. / Levene, Malcolm / Lockwood, Charles J. / Marsal, Karel / Makatsariya, Alexander / Nishida, Hiroshi / Ogata, Edward / Papp, Zoltán / Pejaver, Ranjan Kumar / Pooh, Ritsuko K. / Romero, Roberto / Saugstad, Ola D. / Schenker, Joseph G. / Sen, Cihat / Seri, Istvan / Vetter, Klaus / Winn, Hung N. / Young, Bruce K. / Zimmermann, Roland

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Online
ISSN
1619-3997
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Volume 40, Issue 4 (Jun 2012)

Issues

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
  • Corresponding author
  • Department of Pediatric Medicine, Neonatology, Johann-Wolfgang Goethe University, Frankfurt, Germany
  • Email:
/ Wolfgang Kamin
  • Protestant Hospital for Children and Adolescents, Hamm, Germany
/ Gergely Kriván
  • St. Stephen Hospital, Budapest, Hungary
/ Pál Siklós
  • St. Stephen Hospital, Budapest, Hungary
/ Werner Mendling
  • Department of Gynecology, Vivantes Hospital in the Friedrichshain, Berlin, Germany
/ Andrea Wartenberg-Demand
  • Biotest AG, Dreieich, Germany
/ Daniele M. Wolf
  • Biotest AG, Dreieich, Germany
/ Rolf L. Schlösser
  • Department of Pediatric Medicine, Neonatology, Johann-Wolfgang Goethe University, Frankfurt, Germany
Published Online: 2012-02-01 | DOI: https://doi.org/10.1515/jpm-2011-0185

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

About the article

Corresponding author: Horst Buxmann Department of Pediatric Medicine, Neonatology, Johann Wolfgang Goethe University Theodor Stern Kai 7 D-60590 Frankfurt/Main Germany Tel.: +49-69-6301-5524 Fax: +49-69-6301-4757


Received: 2011-08-04

Revised: 2011-12-17

Accepted: 2012-01-02

Published Online: 2012-02-01

Published in Print: 2012-06-01


Citation Information: , ISSN (Online) 1619-3997, ISSN (Print) 0300-5577, DOI: https://doi.org/10.1515/jpm-2011-0185. Export Citation

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