title: Reactogenicity and immunogenicity of a recombinant hepatitis B vaccine compared with a plasma-derived vaccine in young adults.
abstract: A study of the immunogenicity and reactogenicity of three doses of lot L (10, 20, 40 micrograms), two doses of lot N (10, 20 micrograms) of the SmithKline Biologicals recombinant DNA yeast-derived hepatitis B vaccine and a 20 micrograms dose of the Merck, Sharp & Dohme plasma-derived hepatitis B vaccine was conducted in young adults under randomized, double-blind conditions. Immunization was carried out according to a 0, 1, and 6 month vaccination schedule. Results indicated that the yeast-derived hepatitis B vaccine was well tolerated and highly immunogenic. Reactogenicity to both yeast- and plasma-derived vaccines was mild in severity and low in incidence with no significant differences appearing between the study groups. One month after the third dose, the yeast-derived vaccines induced a high degree of seroconversion ranging between 97.8% and 100%. The response was not lot- or dose-dependent. The administration of the plasma-derived vaccine resulted in an anti-HBs geometric mean titre approximately twice as high as those elicited by the different yeast-derived hepatitis B vaccine doses one month after the third inoculation. However, 11 months following the third dose of vaccine, the anti-HBs titres were similar in all groups. Revaccination of subjects who no longer had detectable anti-HBs one year after the last vaccine dose resulted in an anamnestic response.
authors.affiliation: University Children's Hospital, University of Basel, Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Just
authors.forename: R
authors.initials: R
authors.lastname: Berger
authors.forename: V
authors.initials: V
authors.lastname: Just
mesh_terms: D000941:Antigens / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004274:DNA, Recombinant / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000032:analysis; D006801:Humans; D008297:Male; D011897:Random Allocation; D012441:Saccharomyces cerevisiae / Q000235:genetics; D014611:Vaccination / Q000009:adverse effects; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000941:Antigens; D004274:DNA, Recombinant; D006510:Hepatitis B Antibodies; D014614:Vaccines, Synthetic