Overview of clinical studies with hepatitis B vaccine made by recombinant DNA.
The Merck, Sharp and Dohme hepatitis B vaccine formulated from HBsAg produced by a recombinant strain of Saccharomyces cerevisiae has proven to be highly immunogenic and safe. A 10 micrograms dose of the vaccine produced an anti-HBs response of greater than or equal to 10 IU/l in 91% or more of healthy adults who completed the three-dose regimen. Children responded well to all levels of vaccine antigen utilised but developed maximum anti-HBs titres with 5 micrograms doses. The age of the vaccine recipient affected responsiveness. Younger adults (20-29 years) responded more rapidly and with higher anti-HBs titres than did older adults (greater than or equal to 50 years). Children responded faster and with higher anti-HBs levels than younger adults. Clinical reactions reported after vaccination were mild and transient.
D000328:Adult; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004274:DNA, Recombinant; D006510:Hepatitis B Antibodies / Q000096:biosynthesis*; D006514:Hepatitis B Surface Antigens / Q000235:genetics; D017325:Hepatitis B Vaccines; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis; D007223:Infant; D008875:Middle Aged; D011994:Recombinant Proteins; D012441:Saccharomyces cerevisiae / Q000235:genetics; D014761:Viral Hepatitis Vaccines / Q000009:adverse effects / Q000276:immunology*
D004274:DNA, Recombinant; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D007074:Immunoglobulin G; D011994:Recombinant Proteins; D014761:Viral Hepatitis Vaccines