A comparative trial of standard or high-dose S subunit recombinant hepatitis B vaccine versus a vaccine containing S subunit, pre-S1, and pre-S2 particles for revaccination of healthy adult nonresponders.
The efficacy of 10-microg and 40-microg hepatitis B vaccines was compared with that of an investigational vaccine containing pre-S1, pre-S2, and S subunit particles (mixed particle vaccine) in inducing protective anti-hepatitis B surface antigen (anti-HBs) concentrations in 46 otherwise healthy persons who previously did not develop measurable levels of antibodies to at least one complete course of vaccine. A statistically significant difference was seen in the percentage of subjects who developed protective levels of anti-HBs (> or = 10 mIU/mL) with three 40-microg doses of S subunit vaccine versus the other groups. One hundred percent of the 40-microg dose group developed protective anti-HBs titers. No difference in adverse effects was noted.
Bertino
J S
JS
Bassett Healthcare, Cooperstown, New York 13326-1394, USA.
Tirrell
P
P
Greenberg
R N
RN
Keyserling
H L
HL
Poland
G A
GA
Gump
D
D
Kumar
M L
ML
Ramsey
K
K
D000328:Adult; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D006510:Hepatitis B Antibodies / Q000096:biosynthesis*; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D014614:Vaccines, Synthetic / Q000008:administration & dosage
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic