| 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/OtherAbstract:
|
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. |
| | |
Authors:
|
Horst Buxmann; Wolfgang Kamin; Gergely Kriván; Pál Siklós; Werner Mendling; Andrea Wartenberg-Demand; Daniele M Wolf; Rolf L Schlösser |
Related Documents
:
|
6790846 - Lactic acidosis due to pyruvate carboxylase deficiency. 16182036 - Glucose production in response to glucagon is comparable in preterm aga and sga infants. 16498886 - Hepatic fatty cirrhosis in texas white-tailed deer. 2321106 - Visual stool examination--a screening test for infants with prolonged neonatal cholesta... 20840516 - Bed-sharing among six-month-old infants in western sweden. 8645386 - High incidence of cranial ultrasound abnormalities in full-term infants with congenital... |
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 | |
Descriptor/Qualifier:
|
|
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...