title: Safety and immunogenicity of conventional subunit and MF59-adjuvanted influenza vaccines in human immunodeficiency virus-1-seropositive patients.
abstract: In this study of influenza vaccination, 37 human immunodeficiency virus (HIV)-1-seropositive patients were randomized to receive either a vaccine with a conventional subunit or one adjuvanted with MF59. Blood samples were collected at the time of vaccination, and then 30 and 180 days later, to evaluate immunogenicity, CD4+ T-lymphocyte count and HIV-1 RNA levels. Seroconversion rates against the three viral strains included in the vaccine ranged between 44% and 72% and 53% and 68% for the adjuvanted vaccine and the subunit vaccine, respectively. Other criteria of the European Medicines Evaluation Agency were also met. Vaccination was not associated with serious adverse events. Local and systemic effects were mild and of short duration. CD4+ T-lymphocyte counts and viraemia levels were not negatively affected by vaccination. These results confirmed the safety and immunogenicity of these currently available vaccines in HIV-1-seropositive patients, thus supporting the recommendation for influenza immunization in this high-risk category.
authors.affiliation: Laboratory of Hygiene, Department of Biological and Environmental Sciences and Technologies, Faculty of Sciences, University of Lecce, Lecce, Italy. giovanni.gabutti@unile.it
authors.forename: G
authors.initials: G
authors.lastname: Gabutti
authors.forename: M
authors.initials: M
authors.lastname: Guido
authors.forename: P
authors.initials: P
authors.lastname: Durando
authors.forename: A
authors.initials: A
authors.lastname: De Donno
authors.forename: M
authors.initials: M
authors.lastname: Quattrocchi
authors.forename: S
authors.initials: S
authors.lastname: Bacilieri
authors.forename: F
authors.initials: F
authors.lastname: Ansaldi
authors.forename: S
authors.initials: S
authors.lastname: Cataldini
authors.forename: P G
authors.initials: PG
authors.lastname: Chiriacò
authors.forename: M
authors.initials: M
authors.lastname: De Simone
authors.forename: S
authors.initials: S
authors.lastname: Minniti
authors.forename: L
authors.initials: L
authors.lastname: Sticchi
authors.forename: R
authors.initials: R
authors.lastname: Gasparini
mesh_terms: D000276:Adjuvants, Immunologic / Q000494:pharmacology*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000032:analysis; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000166:cytology; D005260:Female; D006679:HIV Seropositivity; D015497:HIV-1 / Q000235:genetics; D006801:Humans; D007252:Influenza Vaccines / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011136:Polysorbates / Q000494:pharmacology*; D012367:RNA, Viral / Q000097:blood; D012306:Risk; D012449:Safety; D013185:Squalene / Q000494:pharmacology*; D013997:Time Factors; D019562:Viral Load; D014766:Viremia / Q000097:blood
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D012367:RNA, Viral; D013185:Squalene