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

Fifty-seven human immunodeficiency virus (HIV)-infected (CDC class A1-2) an d 54 non-HIV-infected adults, not prescreened for influenza susceptibility, were randomized to receive trivalent live attenuated influenza vaccine (LA IV) or placebo intranasally, LAIV was safe and well tolerated with no serio us adverse events attributable to vaccine, Reactogenicity rates were simila r in LAIV and placebo recipients except that runny nose/nasal congestion wa s 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-infe cted LAIV recipients compared with placebo recipients after immunization. S hedding of LAIV and increases in antibody titers were infrequent, consisten t with prior experience in unscreened adults. The data suggest that inadver tent vaccination with LAIV in relatively asymptomatic HIV-infected adults w ould not be associated with frequent significant adverse events.