title: Comparison of thiomersal-free and thiomersal-containing formulations of a recombinant hepatitis B vaccine (Hepavax-Gene) in healthy adults.
abstract: A thiomersal-free (TF) formulation of the recombinant hepatitis B vaccine Hepavax-Gene has been developed. This study compared immunogenicity and safety of Hepavax-Gene, Hepavax-Gene TF and Engerix-B (containing trace amounts of thiomersal) in a large healthy adult population (N=770) using two vaccination schedules: the priming 0-1-2 months or the standard 0-1-6 month schedule. Hepavax-Gene TF was non-inferior to Hepavax-Gene and Engerix-B with respect to seroprotection rates (>or=10I U/L) 1 month after the third vaccination using the 0-1-6 month schedule, with 99.1% for both Hepavax-Gene formulations and 100% for Engerix-B of subjects' seroprotected in each group. The seroprotection rate after the 0-1-2 schedule was 89.6% for Hepavax-Gene TF, lower than for Hepavax-Gene (94.2%) but comparable to Engerix-B (86.4%). Furthermore, Hepavax-Gene TF was as well tolerated as the comparator vaccines.
authors.affiliation: Institutul de Boli Infectioase, Prof. Dr. Matei Bals Str. Dr. Grozovici nr. 1, Sect. 2, 7000 Bucuresti, Romania.
authors.forename: I
authors.initials: I
authors.lastname: Rebedea
authors.forename: I G
authors.initials: IG
authors.lastname: Diaconescu
authors.forename: D
authors.initials: D
authors.lastname: Bach
authors.forename: O
authors.initials: O
authors.lastname: Bartelsen
authors.forename: N
authors.initials: N
authors.lastname: Arndtz
mesh_terms: D000328:Adult; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006515:Hepatitis B virus / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D008875:Middle Aged; D011310:Preservatives, Pharmaceutical / Q000008:administration & dosage*; D013849:Thimerosal / Q000008:administration & dosage*; D019444:Vaccines, DNA / Q000008:administration & dosage* / Q000009:adverse effects; D014614:Vaccines, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
chemical_list: C075654:Engerix-B; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D007074:Immunoglobulin G; D011310:Preservatives, Pharmaceutical; D019444:Vaccines, DNA; D014614:Vaccines, Synthetic; D013849:Thimerosal