Immunogenicity and safety of double versus standard dose of the seasonal influenza vaccine in solid-organ transplant recipients: A randomized controlled trial. Issue 41 (1st October 2018)

• Record Type: Journal Article
• Authors: Mombelli, Matteo; Rettby, Nils; Perreau, Matthieu; Pascual, Manuel; Pantaleo, Giuseppe; Manuel, Oriol
• Is Part Of: Vaccine. Volume 36:Issue 41(2018)
• Page Start: 6163
• Page End: 6169
• Publication Date: 2018-10-01
• Subjects: Influenza vaccine -- Transplant recipients -- Double dose -- Immunogenicity; AE adverse event -- GMT geometric mean titer -- DD double dose -- HA hemagglutinin -- HIA hemagglutination inhibition assay -- HLA human leucocytes antigen -- m-TOR mammalian target of rapamycin -- SD standard dose -- SOT solid-organ transplant -- OR odds ratio; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2018.08.057
• Languages: English
• ISSNs: 0264-410X

Abstract

Abstract: Background: The use of vaccines with higher doses of antigen is an attractive strategy to improve the immunogenicity of influenza vaccination in transplant recipients. However, the effect of vaccination with a double-dose (DD) containing 30 µg of antigen in this population remains unknown. Methods: We performed a randomized controlled trial to compare the immunogenicity and safety of DD (30 µg) vs. standard dose (SD, 15 µg) of a trivalent inactivated influenza vaccine in kidney and liver transplant recipients. Immunogenicity was assessed by hemagglutination-inhibition assay. Vaccine response was defined as seroconversion to at least one viral strain 2 weeks after vaccination and seroprotection as a titer ≥40. Results: Sixty-three kidney and 16 liver transplant recipients were enrolled. Forty patients received the DD and 39 the SD vaccine. Overall, 40% of patients in the DD compared to 26% in the SD group ( P = 0.174) responded to vaccine. In the DD arm, more patients were seroprotected to all viral strains after vaccination (88% vs 69%, P = 0.048). Post vaccination geometric mean titers of antibodies were 131.9 vs. 89.7 ( P = 0.187) for H1N1, 185.4 vs. 138.7 ( P = 0.182) for H3N2, and 96.6 vs. 68.8 ( P = 0.081) for influenza B with the DD vs. SD. In both groups, most of the adverse events were mild and no vaccine-related severe adverse events were observed. Conclusion: Double-dose influenza vaccine is safe and may increase antibody response in transplant recipients. In this population, DD vaccination could be an alternative when high-dose vaccine is not available. NCT02746783.