title: Long-term immunogenicity after one and two doses of a monovalent MF59-adjuvanted A/H1N1 Influenza virus vaccine coadministered with the seasonal 2009-2010 nonadjuvanted Influenza virus vaccine in HIV-infected children, adolescents, and young adults in a randomized controlled trial.
abstract: Few data are available on the safety and long-term immunogenicity of A/H1N1 pandemic influenza vaccines for HIV-infected pediatric patients. We performed a randomized controlled trial to evaluate the safety and long-term immunogenicity of 1 versus 2 doses of the 2009 monovalent pandemic influenza A/H1N1 MF59-adjuvanted vaccine (PV) coadministered with the seasonal 2009-2010 trivalent nonadjuvanted influenza vaccine (SV) to HIV-infected children, adolescents, and young adults. A total of 66 HIV-infected patients aged 9 to 26 years were randomized to receive one (group 1) or two (group 2) doses of PV coadministered with 1 dose of SV. The main outcome was the seroconversion rate for PV at 1 month. Secondary outcomes were the geometric mean titer ratios and the seroprotection rates at 1 month for all vaccines, seroconversion rates at 1 month for SV, and longitudinal changes of antibody titers (ABTs) at 1, 2, 6, and 12 months for all vaccines. Groups 1 and 2 had similar CD4 counts and HIV RNA levels during the study. The seroconversion rate for PV was 100% at 1 month in both groups. ABTs for PV were high during the first 6 months and declined below seroprotection levels thereafter. Longitudinal changes in ABTs were similar in groups 1 and 2 for both PV and SV. The side effects of vaccination were mild and mostly local. In HIV-infected children, adolescents, and young adults, the immune response triggered by a single dose of PV was similar to that obtained with a double dose and was associated with long-term antibody response.
authors.affiliation: Pediatric Clinic, L. Sacco Hospital, University of Milan, G.B. Grassi, 74-20157 Milan, Italy. alessandra.vigano@unimi.it
authors.forename: Alessandra
authors.initials: A
authors.lastname: Viganò
authors.forename: Vania
authors.initials: V
authors.lastname: Giacomet
authors.forename: Elena
authors.initials: E
authors.lastname: Pariani
authors.forename: Elisa
authors.initials: E
authors.lastname: Giani
authors.forename: Valeria
authors.initials: V
authors.lastname: Manfredini
authors.forename: Giorgio
authors.initials: G
authors.lastname: Bedogni
authors.forename: Paola
authors.initials: P
authors.lastname: Erba
authors.forename: Antonella
authors.initials: A
authors.lastname: Amendola
authors.forename: Alessandro
authors.initials: A
authors.lastname: Zanetti
authors.forename: Gianvincenzo
authors.initials: G
authors.lastname: Zuccotti
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D002648:Child; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000276:immunology; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D008297:Male; D058873:Pandemics; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects; D012621:Seasons; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene