Trivalent inactivated influenza vaccine in African adults infected with human immunodeficient virus: double blind, randomized clinical trial of efficacy, immunogenicity, and safety.

摘要: Background. Data on the efficacy of trivalent, inactivated influenza vaccine (TIV) in HIV-infected adults, particularly Africa, are limited. This study evaluated safety, immunogenicity, and TIV adults. Methods. In Johannesburg, South we undertook a randomized, double-blind, placebo-controlled trial involving 506 Subjects included 157 individuals who were antiretroviral treatment (ART) naive 349 stable-ART. Participants randomly assigned to receive or normal saline intramuscularly. Oropharyngeal swabs obtained at illness visits during season tested by shell vial culture RT PCR assay for virus. Immune response was hemagglutinin antibody inhibition (HAI) nested cohort. The primary outcome involved against confirmed illness. is registered with ClinicalTrials.gov, number NCT00757900. Results. 75.5% (95% CI: 9.2%-95.6%); risk difference 0.18 per 100 person-weeks recipients. Among recipients, seroconversion, measured HAI titers, evident 52.6% H1N1, 60.8% H3N2, 53.6% B compared 2.2%, 4.4% placebo recipients (P < .0001). frequency local systemic adverse events post-immunization similar between groups. Conclusions. immunization safe efficacious African adults without underlying co-morbidities. Further evaluation effectiveness warranted severely immunocompromized those co-morbidities such as tuberculosis.