title: Safety and immunogenicity of a monovalent MF59®-adjuvanted A/H1N1 vaccine in HIV-infected children and young adults.
abstract: BACKGROUND
  This Phase IV study evaluated the safety and immunogenicity of a two-dose, MF59®-adjuvanted (Novartis Vaccines, Marburg, Germany), monovalent, A/H1N1 pandemic influenza vaccination schedule in Human Immunodeficiency Virus (HIV) positive children and young adults.
  
  
  METHODS
  A total of 83 children infected with HIV-1, and 37 non-immunocompromised, age-matched controls were enrolled. All participants received two vaccine doses administered three weeks apart. Antibody responses were assessed by haemagglutination assay at baseline, three weeks after each vaccine dose, and six months after immunization. Vaccines were evaluated according to European influenza vaccine licensure criteria.
  
  
  RESULTS
  The investigational vaccine was well tolerated. After the first vaccine dose, seroconversion rates were significantly lower in HIV-positive patients (60%) than controls (82%), with GMTs of 419 and 600, respectively. No significant differences in seroconversion rates were observed between the two study groups in response to the second vaccine dose. Persisting antibody titers were similar for both HIV-positive and non-infected controls, six months after immunization.
  
  
  CONCLUSIONS
  One dose of MF59-adjuvanted vaccine was sufficient to provide adequate levels of seroprotection against A/H1N1 influenza disease in HIV-positive children. However, a two-dose vaccination schedule may be optimal for this population.
authors.affiliation: University Department of Pediatrics, DPUO, Clinical Trial Center Unit, Bambino Gesù Children's Hospital, Piazza S, Onofrio 4, 00165 Rome, Italy. paolo.palma@opbg.net
authors.forename: Paolo
authors.initials: P
authors.lastname: Palma
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Romiti
authors.forename: Stefania
authors.initials: S
authors.lastname: Bernardi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pontrelli
authors.forename: Nadia
authors.initials: N
authors.lastname: Mora
authors.forename: Veronica
authors.initials: V
authors.lastname: Santilli
authors.forename: Hyppolite Kuekou
authors.initials: HK
authors.lastname: Tchidjou
authors.forename: Angela
authors.initials: A
authors.lastname: Aquilani
authors.forename: Nicola
authors.initials: N
authors.lastname: Cotugno
authors.forename: Federico
authors.initials: F
authors.lastname: Alghisi
authors.forename: Vincenzina
authors.initials: V
authors.lastname: Lucidi
authors.forename: Paolo
authors.initials: P
authors.lastname: Rossi
authors.forename: Iyadh
authors.initials: I
authors.lastname: Douagi
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D007251:Influenza, Human / Q000150:complications / Q000276:immunology / Q000517:prevention & control; D008297:Male; D011136:Polysorbates / Q000008:administration & dosage; D011446:Prospective Studies; D012449:Safety; D013185:Squalene / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene