Jump to ContentJump to Main Navigation

Journal of Perinatal Medicine

Official Journal of the World Association of Perinatal Medicine

Editor-in-Chief: Dudenhausen, Joachim W.

Editorial Board Member: / Bancalari, Eduardo / Greenough, 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, M.J.M.C. / Kurjak M.D., Asim / Levene, Malcolm / Lockwood, Charles J. / Marsal, Karel / Makatsariya, Alexander / Nishida, Hiroshi / 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

7 Issues per year

IMPACT FACTOR 2013: 1.425

VolumeIssuePage

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

1 / Wolfgang Kamin2 / Gergely Kriván3 / Pál Siklós3 / Werner Mendling4 / Andrea Wartenberg-Demand5 / Daniele M. Wolf5 / Rolf L. Schlösser1

1Department of Pediatric Medicine, Neonatology, Johann-Wolfgang Goethe University, Frankfurt, Germany

2Protestant Hospital for Children and Adolescents, Hamm, Germany

3St. Stephen Hospital, Budapest, Hungary

4Department of Gynecology, Vivantes Hospital in the Friedrichshain, Berlin, Germany

5Biotest AG, Dreieich, Germany

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

Citation Information: . Volume 40, Issue 4, Pages 433–438, ISSN (Online) 1619-3997, ISSN (Print) 0300-5577, DOI: 10.1515/jpm-2011-0185, February 2012

Publication History

Received:
2011-08-04
Revised:
2011-12-17
Accepted:
2012-01-02
Published Online:
2012-02-01

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

Comments (0)

Please log in or register to comment.
Users without a subscription are not able to see the full content. Please, subscribe or login to access all content.