Immune response of HLA DQ2 positive subjects, vaccinated with HBsAg/AS04, a hepatitis B vaccine with a novel adjuvant

• Published in: Vaccine Vol. 20; no. 19; pp. 2597 - 2602
• Main Authors: Desombere, Isabelle, Van der Wielen, Marie, Van Damme, Pierre, Stoffel, Michel, De Clercq, Norbert, Goilav, Christian, Leroux-Roels, Geert
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 07.06.2002; Elsevier
• Subjects: Adolescent; Adult; Biological and medical sciences; Engerix™-B; Female; Hepatitis B Surface Antigens - administration & dosage; Hepatitis B Surface Antigens - immunology; Hepatitis B vaccination; Hepatitis B Vaccines - administration & dosage; Hepatitis B Vaccines - adverse effects; Hepatitis B Vaccines - immunology; Hepatitis B virus; HLA DQ2; HLA-DQ Antigens - blood; Human viral diseases; Humans; Infectious diseases; Male; Medical sciences; Middle Aged; Viral diseases; Viral hepatitis; Hepatitis B vaccination; Engerix™-B; HLA DQ2; Human; HLA-System; Hepatitis B surface antigen; Immune response; Class II histocompatibility antigen; Orthohepadnavirus; Hepatic disease; Vaccine; Infection; Virus; Viral hepatitis B; HLA-DQ-Locus; Allele; Immunogenicity; Hepadnaviridae; Viral disease; Immunological adjuvant; Digestive diseases; Hepatitis B virus
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/S0264-410X(02)00150-0

About 5–10% of the general adult population respond inadequately to hepatitis B vaccination. The histocompatibility leucocyte antigen (HLA) DQ2, DR3 and DR7 phenotypes have been linked with non-responsiveness to hepatitis B vaccination. A first part of our study determined the prevalence of the HLA DQ2 allele in a healthy population, aged 15–50 years. We found 35% of our study population ( n=1008) positive for the HLA DQ2 allele. Positive subjects for HLA DQ2 were subsequently invited to participate in a trial and were to be given either the HBsAg/AS04 hepatitis B vaccine or a licensed hepatitis B vaccine (Engerix™-B). 1 Note: Engerix™-B is a trademark of GlaxoSmithKline Biologicals, Rixensart, Belgium. 1 Both contained 20 μg of recombinant HBsAg. The HBsAg/AS04 vaccine was administered on a 0 and 6 months schedule whilst the comparator vaccine was given according to the standard 0, 1 and 6 months schedule. The experimental vaccine was formulated on a novel adjuvant containing 3′ deacylated monophosphoryl lipid A (3D-MPL) and alum. A total of 230 subjects were enrolled into the vaccination study. At month 7, 99% of the subjects had a protective titre (≥10 mIU/ml) with a geometric mean titre (GMT) of 6613 mIU/ml in the group receiving HBsAg/AS04 versus 97% seroprotected with a GMT of 2315 mIU/ml in the other group. Both vaccines, with their respective schedule, give very high seroprotection rates (>96%). Our data suggest that HLA DQ2 positivity is not a good marker for non- or poor-responsiveness. The HBsAg/AS04 vaccine was more reactogenic mainly because of an increased local reactogenicity. Both vaccines, especially HBsAg/AS04, are highly immunogenic and well tolerated by the study subjects.