Reactogenicity and immunogenicity of a new recombinant hepatitis B vaccine containing Pre S antigens: a preliminary report.
A new vaccine against hepatitis B virus (HBV) infection, produced in mammalian Chinese hamster ovary (CHO) cells, contains the small(s), middle (Pre S2) and large (Pre S1) surface proteins of HBV. Three injections of a 5-micrograms or 10-micrograms dose were administered intramuscularly (i.m.) at 0, 1 and 6 months to a group of 105 young adults, who were monitored for a period of 6 months after the third injection. Seroconversion rates were 100% after the second injection of the 5-micrograms or 10-micrograms dose. Geometric mean titres of HBsAb at 1 month after the third injection were 12,156 mIU ml-1 and 13,482 mIU ml-1 in those receiving the 5-micrograms and 10-micrograms dose respectively. The vaccine was well tolerated with no significant adverse events. These preliminary results suggest that the Pre S-s recombinant vaccine, produced in mammalian cells, is highly immunogenic, leading to 100% seroconversion in the population tested after injection of only two doses of 5 micrograms.
Hourvitz
A
A
Medical Corps, Israel Defence Forces, Jerusalem, Israel.
Mosseri
R
R
Solomon
A
A
Yehezkelli
Y
Y
Atsmon
J
J
Danon
Y L
YL
Koren
R
R
Shouval
D
D
D000293:Adolescent; D000328:Adult; D000818:Animals; D000917:Antibody Formation; D016466:CHO Cells; D006224:Cricetinae; D005260:Female; D006509:Hepatitis B / Q000276:immunology*; D006510:Hepatitis B Antibodies / Q000032:analysis; D006512:Hepatitis B Core Antigens / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D008297:Male; D012723:Sex; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
D006510:Hepatitis B Antibodies; D006512:Hepatitis B Core Antigens; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic