title: A study to assess the immunogenicity, reactogenicity and safety of hepatitis A vaccine administered subcutaneously to patients with congenital coagulation disorders.
abstract: The objective was to compare the immunogenicity, reactogenicity and safety of an inactivated hepatitis A vaccine administered subcutaneously to patients with congenital coagulation disorders. Subjects, 97 patients with congenital coagulation disorders (67 men aged > 16 and 30 children aged ≤ 16 years), received hepatitis A vaccine administered at 1440 ELISA (enzyme linked immunosorbent assay) units (ELU) to the adult group and at 720 ELU to the child group at 0 and 6 months by the subcutaneous route. The vaccine was well tolerated, with the incidence of adverse events decreasing with subsequent administration of vaccine. Overall, 90% of subjects seroconverted 1 month after the booster (95% confidence interval 76-97%), with 100% seroconversion occurring in the child group compared with 85% in the adult group. There was a corresponding progressive rise in geometric mean titres in each group and no significant difference in the geometric mean titres was found between the two groups. Of the subjects, 29% were HIV positive, 3% of children compared with 40% of adults. A lower rate of seroconversion was observed in subjects with low CD4 counts. Administration of two doses of an inactivated hepatitis A vaccine at 1440 ELU in adults and 720 ELU in children is safe and highly immunogenic when given by the subcutaneous route.
authors.affiliation: Academic Unit of Travel Medicine and Vaccines, Royal Free Hospital School of Medicine, Rowland Hill Street, London NW3 2PF, UKHaemophilia Centre and Haemostasis Unit, Royal Free Hampstead NHS Trust, London NW3 2QG, UKSmithKline Beecham Pharmaceuticals, Mundells, Welwyn Garden City, Herts. AL7 1EY, UK.
authors.forename: J N
authors.initials: JN
authors.lastname: Zuckerman
authors.affiliation: Academic Unit of Travel Medicine and Vaccines, Royal Free Hospital School of Medicine, Rowland Hill Street, London NW3 2PF, UKHaemophilia Centre and Haemostasis Unit, Royal Free Hampstead NHS Trust, London NW3 2QG, UKSmithKline Beecham Pharmaceuticals, Mundells, Welwyn Garden City, Herts. AL7 1EY, UK.
authors.forename: S
authors.initials: S
authors.lastname: Moore
authors.affiliation: Academic Unit of Travel Medicine and Vaccines, Royal Free Hospital School of Medicine, Rowland Hill Street, London NW3 2PF, UKHaemophilia Centre and Haemostasis Unit, Royal Free Hampstead NHS Trust, London NW3 2QG, UKSmithKline Beecham Pharmaceuticals, Mundells, Welwyn Garden City, Herts. AL7 1EY, UK.
authors.forename: J
authors.initials: J
authors.lastname: Smith
authors.affiliation: Academic Unit of Travel Medicine and Vaccines, Royal Free Hospital School of Medicine, Rowland Hill Street, London NW3 2PF, UKHaemophilia Centre and Haemostasis Unit, Royal Free Hampstead NHS Trust, London NW3 2QG, UKSmithKline Beecham Pharmaceuticals, Mundells, Welwyn Garden City, Herts. AL7 1EY, UK.
authors.forename: H
authors.initials: H
authors.lastname: Tyrrell
authors.affiliation: Academic Unit of Travel Medicine and Vaccines, Royal Free Hospital School of Medicine, Rowland Hill Street, London NW3 2PF, UKHaemophilia Centre and Haemostasis Unit, Royal Free Hampstead NHS Trust, London NW3 2QG, UKSmithKline Beecham Pharmaceuticals, Mundells, Welwyn Garden City, Herts. AL7 1EY, UK.
authors.forename: A
authors.initials: A
authors.lastname: Baxter
authors.affiliation: Academic Unit of Travel Medicine and Vaccines, Royal Free Hospital School of Medicine, Rowland Hill Street, London NW3 2PF, UKHaemophilia Centre and Haemostasis Unit, Royal Free Hampstead NHS Trust, London NW3 2QG, UKSmithKline Beecham Pharmaceuticals, Mundells, Welwyn Garden City, Herts. AL7 1EY, UK.
authors.forename: C A
authors.initials: CA
authors.lastname: Lee
keywords: hepatitis A vaccine; immunogenicity; subcutaneous