The immunogenicity and reactogenicity profile of a candidate hepatitis B vaccine in an adult vaccine non-responder population.
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 m IU/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 123222 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.
Jacques
P
P
Interdisciplinaire Dienst voor het Welzijn, IDEWE, Leuven, Belgium.
Moens
G
G
Desombere
I
I
Dewijngaert
J
J
Leroux-Roels
G
G
Wettendorff
M
M
Thoelen
S
S
D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000096:biosynthesis / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000009:adverse effects / Q000097:blood / Q000276:immunology / Q000627:therapeutic use; D017325:Hepatitis B Vaccines / Q000009:adverse effects* / Q000276:immunology* / Q000627:therapeutic use; D006515:Hepatitis B virus / Q000276:immunology*; D006650:Histocompatibility Testing; D006801:Humans; D007111:Immunity, Cellular / Q000276:immunology; D007115:Immunization Schedule; D008213:Lymphocyte Activation / Q000276:immunology; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use
D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined; D014614:Vaccines, Synthetic