ABSTRACT
Following the demonstration of a fully satisfactory immunogenic activity of a hepatitis B vaccination protocol consisting of three doses given at the 3rd and 5th months of age with a booster at 11, it was possible to administer this vaccine at the same times as the vaccinations for diphtheria, tetanus and polio which are mandatory in Italy at those ages. A field trial of this protocol in a hyperendemic area near Naples (prevalence of HBsAg about 14%) started on January 1987. The French vaccine, Hevac B, Pasteur, was used. At this time compliance is 99%, and fully satisfactory results both in terms of seroconversion rate (96.3%) and of mean anti-HBs titre (4,352 mIU/ml) two months after the booster dose have been obtained. In this paper we demonstrate that even for a new hepatitis B vaccine prepared by a DNA-recombinant technique (Engerix B, SK & F) recently introduced in Italy, the same schedule can be used. In fact two doses of this vaccine, the first given at three months of age and the second two months later, resulted in a 100% seroconversion rate and a mean anti-HBs titre of 560 mIU/ml. Two months after the booster given at 11 months of age the mean anti-HBs titre was 12,100.
Subject(s)
Hepatitis B/prevention & control , Immunization Schedule , Viral Hepatitis Vaccines/administration & dosage , Drug Evaluation , Hepatitis B Vaccines , Humans , Infant , ItalySubject(s)
Hepatitis B/genetics , Hepatitis D/genetics , Adolescent , Adult , Aged , Carrier State , Child , Chronic Disease , Female , Hepatitis B/complications , Hepatitis B Surface Antigens/analysis , Hepatitis D/complications , Humans , Male , Middle Aged , RiskABSTRACT
74 healthy babies born to mothers positive for hepatitis B surface antigen (HBsAg) were randomly divided at birth to receive either HB immunoglobulin and 2 doses of HB vaccine 2 months apart, or HB immunoglobulin and 3 doses of HB vaccine 1 month apart. 80 healthy babies born to HBsAg, anti-HBs, and anti-HB core (c) negative mothers were randomly divided at birth to receive either 2 doses of vaccine 2 months apart or 3 doses 1 month apart. The seroconversion rates and the geometric means of anti-HBs titres were lower in both groups of babies given 2 doses of vaccine than in the groups given 3 doses. 60 pairs of children at risk, aged 1 to 12 years and HBsAg, anti-HBs, and anti-HBc negative, were randomly divided to receive either the 2-dose regimen or the 3-dose regimen. The seroconversion rates and the geometric means of anti-HBs titres were satisfactory in both groups.