Deepali Kumar1, Patricia Campbell, Katja Hoschler, Luis Hidalgo, Mona Al-Dabbagh, Leticia Wilson, Atul Humar. 1. 1 Multi-Organ Transplant Program, University Health Network, Toronto, Ontario, Canada. 2 Department of Medicine, University of Alberta, Edmonton, Canada. 3 Public Health England, London, United Kingdom. 4 Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada. 5 Department of Pediatrics, King Abdulaziz Medical City, Jeddah, Saudi Arabia. 6 Li Ka Shing Institute of Virology, University of Alberta, Edmonton, Alberta, Canada.
Abstract
BACKGROUND:Influenza vaccine containing an oil-in-water emulsion adjuvant (MF-59) may lead to greater immunogenicity in organ transplant recipients. However, alloimmunization may be a concern with adjuvanted vaccines. METHODS: We conducted a randomized trial comparing the safety and immunogenicity of adjuvanted versus nonadjuvanted influenza vaccine in adult kidney transplant patients. Patients were randomized 1:1 to receive 2012 to 2013 influenza vaccine with or without MF59 adjuvant. Preimmunization and postimmunization sera underwent strain-specific hemagglutination inhibition assay. HLA alloantibody was determined by Luminex single-antigen bead assay. RESULTS: We randomized 68 patients and 60 (29 nonadjuvanted; 31 adjuvanted) had complete samples available at follow-up. Seroconversion to at least 1 of 3 influenza antigens was present in 71.0% versus 55.2% in adjuvanted versus nonadjuvanted vaccine respectively (P = 0.21). Geometric mean titers and seroprotection rates were similar between groups. Seroconversion rates were especially low in those on MMF of 2 g or greater daily (44.4% vs 71.4%; P = 0.047). In the subgroup of patients 18 to 64 years old, seroconversion was significantly greater with adjuvanted vaccine (odds ratio, 6.10; 95% confidence interval, 1.25-28.6). There were no increases in HLA alloantibodies in patients who received adjuvanted vaccine. CONCLUSIONS: Adjuvanted vaccine was safe and had similar immunogenicity to standard vaccine in the overall transplant cohort but did show a potential immunogenicity benefit for the 18 to 64 years age group.
RCT Entities:
BACKGROUND: Influenza vaccine containing an oil-in-water emulsion adjuvant (MF-59) may lead to greater immunogenicity in organ transplant recipients. However, alloimmunization may be a concern with adjuvanted vaccines. METHODS: We conducted a randomized trial comparing the safety and immunogenicity of adjuvanted versus nonadjuvanted influenza vaccine in adult kidney transplant patients. Patients were randomized 1:1 to receive 2012 to 2013 influenza vaccine with or without MF59 adjuvant. Preimmunization and postimmunization sera underwent strain-specific hemagglutination inhibition assay. HLA alloantibody was determined by Luminex single-antigen bead assay. RESULTS: We randomized 68 patients and 60 (29 nonadjuvanted; 31 adjuvanted) had complete samples available at follow-up. Seroconversion to at least 1 of 3 influenza antigens was present in 71.0% versus 55.2% in adjuvanted versus nonadjuvanted vaccine respectively (P = 0.21). Geometric mean titers and seroprotection rates were similar between groups. Seroconversion rates were especially low in those on MMF of 2 g or greater daily (44.4% vs 71.4%; P = 0.047). In the subgroup of patients 18 to 64 years old, seroconversion was significantly greater with adjuvanted vaccine (odds ratio, 6.10; 95% confidence interval, 1.25-28.6). There were no increases in HLA alloantibodies in patients who received adjuvanted vaccine. CONCLUSIONS: Adjuvanted vaccine was safe and had similar immunogenicity to standard vaccine in the overall transplant cohort but did show a potential immunogenicity benefit for the 18 to 64 years age group.
Authors: Ji Yun Noh; Joon Young Song; Won Suk Choi; Jacob Lee; Yu Bin Seo; Young Joo Kwon; Gang Jee Ko; Dae Ryong Cha; Young Sun Kang; Young-Ki Lee; Hee Jin Cheong; Woo Joo Kim Journal: Hum Vaccin Immunother Date: 2016-11 Impact factor: 3.452
Authors: Alex C D Salyer; Giuseppe Caruso; Karishma K Khetani; Lauren M Fox; Subbalakshmi S Malladi; Sunil A David Journal: PLoS One Date: 2016-02-26 Impact factor: 3.240