The immunogenicity and reactogenicity profile of a candidate hepatitis B vaccine in an adult vaccine non-responder population

• Published in: Vaccine Vol. 20; no. 31; pp. 3644 - 3649
• Main Authors: Jacques, P, Moens, G, Desombere, I, Dewijngaert, J, Leroux-Roels, G, Wettendorff, M, Thoelen, S
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.11.2002; Elsevier
• Subjects: Adjuvants, Immunologic - adverse effects; Adjuvants, Immunologic - therapeutic use; Adult; Biological and medical sciences; Female; Fundamental and applied biological sciences. Psychology; Hepatitis B; Hepatitis B - prevention & control; Hepatitis B Antibodies - biosynthesis; Hepatitis B Antibodies - blood; Hepatitis B Surface Antigens - adverse effects; Hepatitis B Surface Antigens - blood; Hepatitis B Surface Antigens - immunology; Hepatitis B Surface Antigens - therapeutic use; Hepatitis B Vaccines - adverse effects; Hepatitis B Vaccines - immunology; Hepatitis B Vaccines - therapeutic use; Hepatitis B virus; Hepatitis B virus - immunology; Histocompatibility Testing; Humans; Immunity, Cellular - immunology; Immunization Schedule; Immunogenicity; Lymphocyte Activation - immunology; Male; Microbiology; Middle Aged; Reactogenicity; Single-Blind Method; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies; Vaccines, Combined - adverse effects; Vaccines, Combined - immunology; Vaccines, Combined - therapeutic use; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; Vaccines, Synthetic - therapeutic use; Virology; Immunogenicity; Reactogenicity; Hepatitis B; Human; Immune response; Treatment efficiency; Vaccination; Hepatic disease; Non response; Vaccine; Infection; Viral hepatitis B; Viral disease; Digestive diseases; Adult
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/S0264-410X(02)00397-3

Approximately 5% of vaccinees display an inadequate response after the administration of the standard three dose hepatitis B vaccine. A new hepatitis B vaccine (HBsAg/AS04) formulated with the adjuvant AS04 which contains 3′-deacylated monophosphoryl lipid A (3D-MPL) and alum has been developed. AS04 enhances the immune response which may be beneficial to non-responders. In a single-blind, randomised study, we tested the immunogenicity and reactogenicity of the new vaccine with that of commercially established hepatitis B vaccine, both on a 0, 1, 6 months schedule in 20–60 years old non-responders (titre <10 mIU/ml after four doses of hepatitis B vaccine). One month after the first dose the seroprotection rate was 44% for group 1 (58 subjects) receiving the established vaccine versus 66% for group 2 receiving HBsAg/AS04 (57 subjects) ( P=0.03). One month after the second dose this was 58 and 81%, respectively ( P<0.005) and 1 month after the third dose this was 68 and 98%, respectively ( P<0.001). One month after each dose, GMTs were 34, 56 and 111 mIU/ml for group 1 versus 123, 222 and 1937 mIU/ml for the HBsAg/AS04 group ( P<0.05, <0.01 and 0.0001, respectively). Pain at the injection site was the most commonly reported local symptom and very few symptoms were scored as severe. In this group of adult non-responders to previous hepatitis vaccination, the HBsAg/AS04 vaccine was well tolerated and induced, at all time-points, a superior immune response compared to the licensed hepatitis B vaccine.