title: Comparison of the safety, vaccine virus shedding, and immunogenicity of influenza virus vaccine, trivalent, types A and B, live cold-adapted, administered to human immunodeficiency virus (HIV)-infected and non-HIV-infected adults.
abstract: Fifty-seven human immunodeficiency virus (HIV)-infected (CDC class A1-2) and 54 non-HIV-infected adults, not prescreened for influenza susceptibility, were randomized to receive trivalent live attenuated influenza vaccine (LAIV) or placebo intranasally. LAIV was safe and well tolerated with no serious adverse events attributable to vaccine. Reactogenicity rates were similar in LAIV and placebo recipients except that runny nose/nasal congestion was significantly more common in LAIV recipients regardless of HIV status. No prolonged shedding of LAIV was observed in HIV-infected participants. HIV RNA levels were not increased and CD4 counts were not decreased in HIV-infected LAIV recipients compared with placebo recipients after immunization. Shedding of LAIV and increases in antibody titers were infrequent, consistent with prior experience in unscreened adults. The data suggest that inadvertent vaccination with LAIV in relatively asymptomatic HIV-infected adults would not be associated with frequent significant adverse events.
authors.affiliation: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD 21201, USA. jking@som.umaryland.edu
authors.forename: J C
authors.initials: JC
authors.lastname: King
authors.forename: J
authors.initials: J
authors.lastname: Treanor
authors.forename: P E
authors.initials: PE
authors.lastname: Fast
authors.forename: M
authors.initials: M
authors.lastname: Wolff
authors.forename: L
authors.initials: L
authors.lastname: Yan
authors.forename: D
authors.initials: D
authors.lastname: Iacuzio
authors.forename: B
authors.initials: B
authors.lastname: Readmond
authors.forename: D
authors.initials: D
authors.lastname: O'Brien
authors.forename: K
authors.initials: K
authors.lastname: Mallon
authors.forename: W E
authors.initials: WE
authors.lastname: Highsmith
authors.forename: J S
authors.initials: JS
authors.lastname: Lambert
authors.forename: R B
authors.initials: RB
authors.lastname: Belshe
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D003080:Cold Temperature; D005260:Female; D015658:HIV Infections / Q000276:immunology* / Q000821:virology; D015497:HIV-1 / Q000502:physiology; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D009980:Influenza A virus / Q000276:immunology* / Q000302:isolation & purification; D009981:Influenza B virus / Q000276:immunology* / Q000302:isolation & purification; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D008297:Male; D012367:RNA, Viral / Q000097:blood; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D017201:Virus Shedding
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D012367:RNA, Viral; D014613:Vaccines, Attenuated