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No benefit from squalene adjuvant flu vaccine vs adjuvant-free vaccine for heart transplant patients

Emily

Editor, Senior Moderator
More patient got the flu when using a vaccine with squalene adjuvant, than those using a flu vaccine without any adjuvant. (Both vaccine groups had less flu than the unvaccinated controls.)

The Journal of Heart and Lung Transplantation, Volume 24, Issue 5, May 2005, Pages 509-510,
James K. Kirklin

Transplantation infection
Safety and Efficacy of Two Types of Influenza Vaccination in Heart Transplant Recipients: A Prospective Randomised Controlled Study


Gaia Magnani MD, PhDa, Corresponding Author Contact Information, E-mail The Corresponding Author, Elena Falchetti MDa, Gianmatteo Pollini MDb, Letizia Bacchi Reggiani BSca, Francesco Grigioni MDa, Fabio Coccolo MDa, Luciano Potena MDa, Carlo Magelli MDa, Vittorio Sambri MD, PhDb and Angelo Branzi MDa

aInstitute of Cardiology and Section of Microbiology, University of Bologna, S. Orsola Hospital, Via Massarenti, 9, 40138 Bologna, Italy

bDMCSS, University of Bologna, S. Orsola Hospital, Via Massarenti, 9, 40138 Bologna, Italy.

Available online 10 May 2005.

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.
 
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