Z Gastroenterol 2012; 50 - K075
DOI: 10.1055/s-0032-1324010

MF59-Adjuvanted seasonal influenza vaccine including H1N1 leads to robust serological response rates in immunocompromised patients after liver and kidney transplantation

K Wursthorn 1, S Pischke 1, J Buchta 1, B Zacher 1, A Müller-Heine 2, A Großhennig 2, C Schröder 3, C Blume 4, T Ganten 5, CP Strassburg 1, A Koch 2, MP Manns 1
  • 1Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology, Hannover, Germany
  • 2Hannover Medical School, Institute for Biometry, Hannover, Germany
  • 3Hannover Medical School, Institute of Clinical Pharmacology, Hannover, Germany
  • 4Hannover Medical School, Clinic for Nephrology, Hannover, Germany
  • 5University Hospital Heidelberg, Department of Gastroenterology, Infectiology and Intoxication, Heidelberg, Germany

Background and aims: Influenza infection in solid-organ transplant recipients leads to increased morbidity and mortality. Vaccination is preventive despite lower efficacy with approved non-adjuvanted vaccines. The aim of this study was to evaluate the immunogenicity and safety of the MF59-adjuvanted influenza vaccine 2010/11 (Fluad®) in liver/kidney transplant recipients under immunosuppression compared to healthy subjects.

Methods: 61 solid-organ transplant recipients (TX) and 61 age-matched healthy subjects (HC) received a single dose of Fluad® between November 2010 and May 2011at two sites. Achieving serological efficacy criteria outlined by European guidance documents after 21 days in the TX group was the primary endpoint of the study. Secondary endpoints included serological efficacy for H3N2 and B influenza, response rates after 42days and safety.

Results: At day21, 57 TX and 59 HC were available for analysis. 48 TX (84.2%) and 55 HC (93.2%) achieved seroprotection (HI >1:40). Seroconversion (>4fold increase in HI titers) was observed in 34 TX (59.7%) and in 48 HC (81.4%). Geometric mean ratio (GMR) was 9.4 for TX and 17.6 for HC. Therefore all serological efficacy criteria including the primary endpoint were achieved. At day42, of the 56 TX and 60 HC subjects, 45 (80.4%, TX) and 59 (98.3%, HC) gained seroprotection. Seroconversion rates and GMR for TX were 55.4% (n=31) and 8.5, for HC 81.7% (n=49) and 17.2. Serological efficacy criteria were also achieved for H3N2 and B influenza. Seroprotection and seroconversion rates for H3N2at day21 were 96.5% and 70.2% in TX and 100% and 83.1% in HC, at day42 94.6% and 69.6% in TX and 100% and 85% in HC. For B influenza, the respective rates at day21 were 96.5% and 52.6% in TX and 96.6% and 66.1% in HC, at day42 98.2% and 51.8% (TX) and 96.7% and 65.0% (HC). Adverse events (AE) consisted mostly of symptoms at the injection site and flu-like symptoms. Serious adverse events (SAE) occurred in the TX group only including two reports of organ rejection (1 kidney, 1 liver).

Conclusions: A single dose of MF59-adjuvanted seasonal influenza vaccine in liver and kidney transplant recipients is effective and generally well-tolerated.