Hepatitis B vaccine containing surface antigen and selected preS1 and preS2 sequences. 2. Immunogenicity in poor responders to hepatitis B vaccines.
The immunogenicity of a yeast-derived recombinant hepatitis B virus (HBV) vaccine containing surface antigen (S) and selected preS1 and preS2 sequences (S-L*) was compared with that of a vaccine containing S alone (Engerix-B) in 32 healthy adults with a previous history of poor response (anti-HBs < 10 mIU ml-1) after at least three consecutive monthly doses of hepatitis B vaccines. The poor responders were randomized to receive three additional 20-microgram doses of either S-L* or Engerix-B in a double-blind fashion according to a 0-, 1-, 2-month schedule. In vivo humoral and in vitro lymphoproliferative responses to the S and preS regions were monitored. Although the addition of the selected preS sequences to S did not enhance the in vivo humoral anti-HBs response, the administration of the three additional vaccine doses, irrespective of their preS content, induced seroprotective anti-HBs levels in most vaccinees (29/32, 91%). In vitro proliferative responses to HBV surface antigens were only observed in subjects displaying anti-HBs titers > 1000 mIU ml-1 after the third additional vaccine dose.
Leroux-Roels
G
G
Department of Clinical Chemistry, University of Gent, Belgium. Geert.Lerouxroels@rug.ac.be
Desombere
I
I
Cobbaut
L
L
Petit
M A
MA
Desmons
P
P
Hauser
P
P
Delem
A
A
De Grave
D
D
Safary
A
A
D000328:Adult; D000917:Antibody Formation / Q000187:drug effects / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000276:immunology* / Q000627:therapeutic use*; D006801:Humans; D007111:Immunity, Cellular / Q000187:drug effects / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011498:Protein Precursors / Q000276:immunology*
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011498:Protein Precursors; C050806:presurface protein 1, hepatitis B surface antigen; C050807:presurface protein 2, hepatitis B surface antigen