Hepatitis B vaccine containing surface antigen and selected preS1 and preS2 sequences. 1. Safety and immunogenicity in young, healthy adults.
The safety and immunogenicity of a yeast-derived recombinant hepatitis B virus (HBV) vaccine containing surface antigen (S) and selected preS1 and preS2 sequences (S-L*) were compared with those of a vaccine prepared with S alone (Engerix-B). S-L* consisted of composite particles containing S and L* at a ratio of 70/30. L* encompassed amino acid residues 12-52 of preS1 residues 133-145 of preS2, and the entire S domain. A total of 100 healthy, HBV-seronegative, young adults were randomized to receive 20 micrograms/dose of either S-L* or Engerix-B under double-blind conditions according to a 0-, 1-, 2-, 12-month schedule. In vivo humoral and in vitro lymphoproliferative responses to S and preS regions were monitored. Addition of the selected preS sequences to S did not enhance the in vivo humoral anti-HBs response but improved the in vitro stimulating capacity of the antigen (L*) in S-L* primed subjects.
Leroux-Roels
G
G
Department of Clinical Chemistry, University of Gent, Belgium. Geert.LerouxRoels@rug.ac.be
Desombere
I
I
De Tollenaere
G
G
Petit
M A
MA
Desmons
P
P
Hauser
P
P
Delem
A
A
De Grave
D
D
Safary
A
A
D000328:Adult; 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 / Q000009:adverse effects* / Q000276:immunology* / Q000627:therapeutic use; D006801:Humans; D008213:Lymphocyte Activation / Q000187:drug effects / Q000276:immunology; D008297:Male; 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