Document Detail

An open-label, randomized efficacy and safety trial of subcutaneous and intramuscular BT088 (Fovepta) human hepatitis B immunoglobulin in neonates of HBV-carrier mothers.
MedLine Citation:
PMID:  22752776     Owner:  NLM     Status:  In-Data-Review    
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.
Horst Buxmann; Wolfgang Kamin; Gergely Kriván; Pál Siklós; Werner Mendling; Andrea Wartenberg-Demand; Daniele M Wolf; Rolf L Schlösser
Related Documents :
25093976 - Severe parechovirus infection in norwegian infants.
9165316 - The role of ercp in biliary atresia.
19457876 - Epidemiology of biliary atresia in england and wales (1999-2006).
718946 - A novel method for determining equilibrium constants. ctp:phosphorylcholine cytidyltran...
16490066 - Polyethylene skin wrapping accelerates recovery from hypothermia in very low-birthweigh...
7079036 - Anthropometric determinants of creatinine excretion in preterm infants.
Publication Detail:
Type:  Journal Article     Date:  2012-02-01
Journal Detail:
Title:  Journal of perinatal medicine     Volume:  40     ISSN:  1619-3997     ISO Abbreviation:  J Perinat Med     Publication Date:  2012  
Date Detail:
Created Date:  2012-07-03     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0361031     Medline TA:  J Perinat Med     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  433-8     Citation Subset:  IM    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  Acquisition of full enteral feeds may depend on stooling pattern in very premature infants.
Next Document:  Use of cytomegalovirus hyperimmunoglobulin for prevention of congenital cytomegalovirus disease: a r...