title: Comparative study of the immunogenicity and safety of Engerix-B administered at 0, 1, 2 and 12 months and Recombivax HB administered at 0, 1, and 6 months in healthy adults.
abstract: A randomized trial compared the safety and immunogenicity of Engerix-B (EB) 20 micrograms administered intramuscularly (IM) at 0, 1, 2, and 12 months with Recombivax HB (RHB) 10 micrograms administered IM at 0, 1, and 6 months in healthy adults. At months 3 and 6, significantly more subjects who received EB were seroprotected compared to those who received RHB (84 vs 67%, p = 0.0027; 95 vs 76%, p < 0.001, respectively). SP rates were similar between the vaccination groups approximately 1 year after administration of the initial dose (91 and 83%, respectively; p = 0.1). The vaccines were well tolerated with injection site pain being the most commonly reported adverse event.
authors.affiliation: Office of Medical Research, Fairfax Hospital, Falls Church, VA 22046, USA.
authors.forename: V K
authors.initials: VK
authors.lastname: Rustgi
authors.forename: C J
authors.initials: CJ
authors.lastname: Schleupner
authors.forename: D S
authors.initials: DS
authors.lastname: Krause
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D011446:Prospective Studies; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: C075654:Engerix-B; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; C075655:Recombivax HB; D014614:Vaccines, Synthetic