title: Effect of previous or simultaneous immunization with canarypox expressing cytomegalovirus (CMV) glycoprotein B (gB) on response to subunit gB vaccine plus MF59 in healthy CMV-seronegative adults.
abstract: Development of a vaccine for prevention of congenital cytomegalovirus (CMV) disease is a priority. This study evaluated a "prime-boost" strategy by comparing the safety and immunogenicity of 3 doses of subunit CMV glycoprotein B (gB) vaccine plus MF59 (a squalene-in-water emulsion), 2 doses of a canarypox recombinant vaccine expressing CMVgB (ALVAC-CMVgB) followed by 2 doses of the subunit gB vaccine, 3 doses of both vaccines administered concomitantly, and placebo in 105 healthy, CMV-seronegative adults. Systemic adverse events were rare, but local reactions were common in all groups. After the first subunit vaccination, neutralizing antibody titers in the prime-boost group were comparable to those in subjects receiving 2 subunit vaccinations, indicating a priming effect of ALVAC-CMVgB. However, after the final dose, antibody and cell-mediated immune responses were not significantly different among the groups. All 3 vaccine regimens induced high-titer antibody and lymphoproliferative responses, but no benefit for priming or simultaneous vaccination was detected.
authors.affiliation: Division of Infectious Diseases, Children's Hospital Medical Center, CH-1, 3333 Burnet Ave. Rm. 1345, Cincinnati, Ohio 45229-3039, USA. dib@chmcc.org
authors.forename: David I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: Mark R
authors.initials: MR
authors.lastname: Schleiss
authors.forename: Klara
authors.initials: K
authors.lastname: Berencsi
authors.forename: Eva
authors.initials: E
authors.lastname: Gonczol
authors.forename: Michelle
authors.initials: M
authors.lastname: Dickey
authors.forename: Phil
authors.initials: P
authors.lastname: Khoury
authors.forename: Michel
authors.initials: M
authors.lastname: Cadoz
authors.forename: Claude
authors.initials: C
authors.lastname: Meric
authors.forename: John
authors.initials: J
authors.lastname: Zahradnik
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Duliege
authors.forename: Stanley
authors.initials: S
authors.lastname: Plotkin
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D022482:Cytomegalovirus Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D008213:Lymphocyte Activation; D008875:Middle Aged; D011136:Polysorbates / Q000008:administration & dosage; D013185:Squalene / Q000008:administration & dosage / Q000276:immunology; D014611:Vaccination; D022223:Vaccines, Subunit / Q000008:administration & dosage / Q000276:immunology*; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000276:immunology; D014759:Viral Envelope Proteins / Q000235:genetics / Q000276:immunology* / Q000378:metabolism; D014765:Viral Vaccines / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology
chemical_list: C078788:ALVAC vaccine; D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D022482:Cytomegalovirus Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D022223:Vaccines, Subunit; D014614:Vaccines, Synthetic; D014759:Viral Envelope Proteins; D014765:Viral Vaccines; C040495:glycoprotein B, Simplexvirus; D013185:Squalene