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) 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. Investigational trivalent, live attenuated, cold-adapted influenza vaccine (LAIV) is safe, well tolerated, and efficacious against influenza illness in children and adults [1‐4]. Some undiagnosed asymptomatic or mildly symptomatic human immunodeficiency virus (HIV)‐infected persons might be exposed to LAIV inadvertently if this vaccine were licensed and gained wide acceptance. Therefore, an assessment of the safety, duration of LAIV virus shedding, effect on HIV replication, and effect on CD4 cell counts in relatively asymptomatic HIV-infected persons would allow clinicians and public health officials