title: Immunogenicity and safety of respiratory syncytial virus subunit vaccine in seropositive children 18-36 months old.
abstract: Twenty-six children (aged 18-36 months) previously hospitalized for respiratory syncytial virus (RSV) infection were randomized to receive 50 micrograms of an RSV subunit vaccine composed primarily of F glycoprotein or saline placebo by intramuscular injection. Serum was obtained at entry and at 1 and 6 months after vaccination for detection of antibody to F glycoprotein and G glycoprotein of subtypes A (Ga) or B (Gb) and of neutralizing antibody (nAb). At 1 month, by comparing the baseline values, vaccinees had statistically significant increases in geometric mean antibody titer (GMT) of more than fourfold to F (P = .0001), Ga (P = .0001), Gb (P = .003), and nAb (P = .009). No differences in GMT were observed between F protein vaccine and placebo recipients at entry, nor between placebo recipients at entry and 1 month. RSV infections were identified in 7 placebo recipients (4 by both viral identification and seroconversion, 3 by seroconversion alone). No vaccine recipient had RSV infection documented in the 6 months after vaccination (P = .003). There were no significant vaccine-related side effects, and no evidence of enhanced respiratory illnesses was observed. The subunit F protein vaccine appears safe and immunogenic and may prevent infection in healthy children primed by prior RSV infection.
authors.affiliation: Department of Pediatrics, State University of New York, Buffalo School of Medicine.
authors.forename: D A
authors.initials: DA
authors.lastname: Tristram
authors.forename: R C
authors.initials: RC
authors.lastname: Welliver
authors.forename: C K
authors.initials: CK
authors.lastname: Mohar
authors.forename: D A
authors.initials: DA
authors.lastname: Hogerman
authors.forename: S W
authors.initials: SW
authors.lastname: Hildreth
authors.forename: P
authors.initials: P
authors.lastname: Paradiso
mesh_terms: D000914:Antibodies, Viral / Q000032:analysis* / Q000097:blood; D002675:Child, Preschool; D005260:Female; D015707:HN Protein; D006801:Humans; D007071:Immunoglobulin A, Secretory / Q000032:analysis; D007073:Immunoglobulin E / Q000032:analysis; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D008297:Male; D012136:Respiratory Syncytial Viruses / Q000276:immunology*; D014759:Viral Envelope Proteins; D014764:Viral Proteins / Q000276:immunology*; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D015707:HN Protein; D007071:Immunoglobulin A, Secretory; D007074:Immunoglobulin G; D014759:Viral Envelope Proteins; D014764:Viral Proteins; D014765:Viral Vaccines; C116204:attachment protein G; D007073:Immunoglobulin E