title: Safety and immunogenicity of a monovalent 2009 influenza A/H1N1v vaccine adjuvanted with AS03A or unadjuvanted in HIV-infected adults: a randomized, controlled trial.
abstract: BACKGROUND
  Human immunodeficiency virus (HIV)-infected patients have decreased immune response to vaccines. Few data are available about pandemic flu vaccination in this population.
  
  
  METHODS
  We conducted a multicenter, patient-blinded, randomized trial in a cohort of HIV-infected adults. Patients received 2 injections 21 days apart of a AS03(A)-adjuvanted H1N1v vaccine containing 3.75 μg hemagglutinin (HA) or a nonadjuvanted H1N1v vaccine containing 15 μg HA to assess hemagglutination inhibition (HI) response and safety.
  
  
  RESULTS
  A total of 309 patients were randomized, and 306 were vaccinated. After the first vaccine dose, HI titers ≥1:40 were observed in 93.4% of the patients in the adjuvanted group (A group) (n = 155) and in 75.5% in the nonadjuvanted group (B group) (n = 151) (P < .001); seroconversion rates were 88.8% and 71.2%, and factor increases in geometric mean titers (GMT) of 21.9 and 15.1, respectively. After 2 injections, 98.6% of patients of the A group and 92.1% of the B group demonstrated HI titers ≥1:40 (P = .018); seroconversion rates were 96.5% and 87.1%, respectively, and factor increases in GMT were 45.5 and 21.2, respectively. The majority of adverse events were mild to moderate in severity; no impact on CD4+ cell count or viral load has been detected.
  
  
  CONCLUSIONS
  In HIV-1-infected adults, the AS03(A)-adjuvanted H1N1v vaccine yielded a higher immune response than did the nonadjuvanted one, with no impact on HIV infection.
authors.affiliation: Université Paris Descartes, France. odile.launay@cch.aphp.fr
authors.forename: Odile
authors.initials: O
authors.lastname: Launay
authors.forename: Corinne
authors.initials: C
authors.lastname: Desaint
authors.forename: Christine
authors.initials: C
authors.lastname: Durier
authors.forename: Pierre
authors.initials: P
authors.lastname: Loulergue
authors.forename: Xavier
authors.initials: X
authors.lastname: Duval
authors.forename: Christine
authors.initials: C
authors.lastname: Jacomet
authors.forename: Gilles
authors.initials: G
authors.lastname: Pialoux
authors.forename: Jade
authors.initials: J
authors.lastname: Ghosn
authors.forename: François
authors.initials: F
authors.lastname: Raffi
authors.forename: David
authors.initials: D
authors.lastname: Rey
authors.forename: Faiza
authors.initials: F
authors.lastname: Ajana
authors.forename: Nathalie
authors.initials: N
authors.lastname: Colin de Verdière
authors.forename: Jacques
authors.initials: J
authors.lastname: Reynes
authors.forename: Valérie
authors.initials: V
authors.lastname: Foubert
authors.forename: François
authors.initials: F
authors.lastname: Roman
authors.forename: Jeanne-Marie
authors.initials: JM
authors.lastname: Devaster
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Delfraissy
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Aboulker
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; D013185:Squalene