Background and Aims Postnatal active and passive immunization is recommended for prevention of hepatits-B-virus (HBV) transmission in any offspring of a HBV-carrier mother. To improve convenience in application for neonates and for doctors we studied the efficacy and safety of a subcutaneous (s.c.) human hepatitis B immunoglobulin (Fovepta).

Methods In an open, prospective multicenter trial neonates of HBV carrier mothers were randomized to receive a single dose of the high concentrated human hepatitis immunoglobulin Fovepta (200 IU, 0.4 ml) either subcutaneously or intramuscularly (i.m.). The passive immunization was combined with an active vaccination against hepatits B. Efficacy was defined as an anti-HBs-serum concentration of >100 IU/L 48 to 72 hours post vaccination. Adverse events (AE) were documented during hospital stay and follow-up surveillance of 7–15 months.

Results 31 neonates were included (17 s.c. and 14 i.m.). One infant of the s.c. group had a post-dose anti-HBs level of 81.0 IU/l. All other study patients reached a level of >100 IU/l. AEs were more often in i.m. group patients, but without statistical significance. There was no AE, which led to discontinuation from the study. 24 of 31 infants completed the follow up period. No hepatits B breakthrough infection was observed.

Conclusions Subcutaneous vaccination with a high concentrated hepatitis immunoglobulin (Fovepta) is effective and safe in newborn infants.

(Main results of the study are accepted for publication in J Perinat Med).