title: Safety and immunogenicity of live attenuated cold-adapted influenza B/Ann Arbor/1/86 reassortant virus vaccine in infants and children.
abstract: A cold-adapted (ca) influenza B reassortant vaccine consisting of two genes encoding the hemagglutinin and neuraminidase from wild-type influenza B/Ann Arbor/1/86 virus and the six internal RNA segments from influenza B/Ann Arbor/1/66 ca virus was evaluated in 18 seropositive and 57 seronegative infants and children. The ca reassortant was infectious in seronegative vaccinees, with an estimated 50% human infectious dose of 10(2.5) TCID50. Nasal wash specimens from vaccinees retained the temperature-sensitive phenotype, indicating that the virus was phenotypically stable after replication in fully susceptible children. The vaccine was highly immunogenic in the seronegative vaccinees; 54% of the seropositive vaccinees also developed an increase in serum antibody. The ca vaccine was well tolerated, with only a mild increase in upper respiratory tract symptoms seen in the seronegative vaccinees. These studies indicate that the B/Ann Arbor/1/86 ca reassortant is safe, immunogenic, and phenotypically stable in infants and children.
authors.affiliation: Department of Pediatrics, Vanderbilt University Medical School, Nashville, Tennessee 37232-2581.
authors.forename: K M
authors.initials: KM
authors.lastname: Edwards
authors.forename: J C
authors.initials: JC
authors.lastname: King
authors.forename: M C
authors.initials: MC
authors.lastname: Steinhoff
authors.forename: J
authors.initials: J
authors.lastname: Thompson
authors.forename: M L
authors.initials: ML
authors.lastname: Clements
authors.forename: P F
authors.initials: PF
authors.lastname: Wright
authors.forename: B R
authors.initials: BR
authors.lastname: Murphy
mesh_terms: D000914:Antibodies, Viral / Q000096:biosynthesis*; D002648:Child; D002675:Child, Preschool; D003080:Cold Temperature; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007223:Infant; D009981:Influenza B virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology*; D007700:Kinetics; D009297:Nasal Mucosa / Q000382:microbiology; D010641:Phenotype; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated; D014614:Vaccines, Synthetic