title: Safety and efficacy of two types of influenza vaccination in heart transplant recipients: a prospective randomised controlled study.
abstract: BACKGROUND
  Influenza may cause severe disease in immunosuppressed patients. Different vaccines have been proved to be efficacious to prevent influenza in tranplant recipients. Since the last five years the addition of adjuvants to improve the immune response to vaccine preparations has been proposed and evaluated. In this study, two antigenically identical vaccines, but different for the presence of adjuvants were randomised among a cohort of heart transplant recipients to evaluate their safety and immunogenicity.
  
  
  METHODS
  58 patients, receiving an heart transplant more than 6 months before, were randomised to receive one shoot vaccination with Fluad (containing the MF59 adjuvant) or Agrippal (no adjuvant added) or to enter the control, not-vaccinated, group. The immune response to influenza was evaluated separately for type A and type B viruses and for the IgG and the IgM antibodies. Patients were clinically evaluated at least monthly up to 6 months.
  
  
  RESULTS
  Influenza symptoms were reported by 33% of patients receiving Fluad, 29% of the Agrippal and 63% of the control group. 4 episodes of acute myocardial rejection >/=3A were identified without difference between the three groups.
  
  
  CONCLUSIONS
  The superior efficacy of vaccines containing adjuvants was not found and the data clearly confirmed that vaccination against influenza is safe and effective in heart transplant recipients. The use of vaccine containing adjuvant substances do not ameliorate the clinical performance of the immunisation suggesting that less expensive influenza vaccine preparation without adjuvant substances could be equally useful to protect heart transplant recipients.
authors.affiliation: Institute of Cardiology and Section of Microbiology, University of Bologna, S. Orsola Hospital, Via Massarenti, 9, 40138 Bologna, Italy. gaiamagnani@virgilio.it
authors.forename: Gaia
authors.initials: G
authors.lastname: Magnani
authors.forename: Elena
authors.initials: E
authors.lastname: Falchetti
authors.forename: Gianmatteo
authors.initials: G
authors.lastname: Pollini
authors.forename: Letizia Bacchi
authors.initials: LB
authors.lastname: Reggiani
authors.forename: Francesco
authors.initials: F
authors.lastname: Grigioni
authors.forename: Fabio
authors.initials: F
authors.lastname: Coccolo
authors.forename: Luciano
authors.initials: L
authors.lastname: Potena
authors.forename: Carlo
authors.initials: C
authors.lastname: Magelli
authors.forename: Vittorio
authors.initials: V
authors.lastname: Sambri
authors.forename: Angelo
authors.initials: A
authors.lastname: Branzi
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D016027:Heart Transplantation / Q000009:adverse effects* / Q000276:immunology; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D007252:Influenza Vaccines / Q000627:therapeutic use*; D007251:Influenza, Human / Q000517:prevention & control* / Q000821:virology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D007252:Influenza Vaccines