title: Effects of antigen dose and immunization regimens on antibody responses to a cytomegalovirus glycoprotein B subunit vaccine.
abstract: The purpose of this phase I study was to evaluate the safety and immunogenicity of 2 doses of cytomegalovirus glycoprotein B (CMV gB)/MF59 vaccine at 3 different immunization schedules. Ninety-five volunteers were randomized to 6 groups. Antibodies to gB represent the majority of the CMV-specific neutralizing response. Three groups received 5 microgram of gB antigen combined with MF59 (a proprietary adjuvant) and 3 groups received a 30-microgram dose at 0, 1, and 2 months; 0, 1, and 4 months; or 0, 1, and 6 months. The vaccine was well tolerated, and there was no significant difference in antibody production between the 2 doses. The vaccine induced highest antibody titers when given at 0, 1, and 6 months. A low dose of CMV gB/MF59 may be the preferred dose for future studies.
authors.affiliation: Saint Louis University Health Sciences Center, Division of Infectious Diseases, St. Louis, MO 63110-0250, USA.
authors.forename: S E
authors.initials: SE
authors.lastname: Frey
authors.forename: C
authors.initials: C
authors.lastname: Harrison
authors.forename: R F
authors.initials: RF
authors.lastname: Pass
authors.forename: E
authors.initials: E
authors.lastname: Yang
authors.forename: D
authors.initials: D
authors.lastname: Boken
authors.forename: R E
authors.initials: RE
authors.lastname: Sekulovich
authors.forename: S
authors.initials: S
authors.lastname: Percell
authors.forename: A E
authors.initials: AE
authors.lastname: Izu
authors.forename: S
authors.initials: S
authors.lastname: Hirabayashi
authors.forename: R L
authors.initials: RL
authors.lastname: Burke
authors.forename: A M
authors.initials: AM
authors.lastname: Duliège
mesh_terms: D000276:Adjuvants, Immunologic; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D000956:Antigens, Viral / Q000008:administration & dosage / Q000276:immunology; D003587:Cytomegalovirus / Q000276:immunology*; D003586:Cytomegalovirus Infections / Q000517:prevention & control; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D008875:Middle Aged; D014759:Viral Envelope Proteins / Q000008:administration & dosage* / Q000276:immunology*; D010948:Viral Plaque Assay; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D000956:Antigens, Viral; D014759:Viral Envelope Proteins; D014765:Viral Vaccines; C040495:glycoprotein B, Simplexvirus