Randomized Controlled Trial of Adjuvanted Versus Nonadjuvanted Influenza Vaccine in Kidney Transplant Recipients.
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.
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.
Deepali
D
Kumar
Patricia
P
Campbell
Katja
K
Hoschler
Luis
L
Hidalgo
Mona
M
Al-Dabbagh
Leticia
L
Wilson
Atul
A
Humar
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D006680:HLA Antigens / Q000276:immunology; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D007518:Isoantibodies / Q000097:blood; D016030:Kidney Transplantation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D009864:Ontario; D011136:Polysorbates / Q000008:administration & dosage* / Q000009:adverse effects; D013185:Squalene / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014612:Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D006680:HLA Antigens; D007252:Influenza Vaccines; D007518:Isoantibodies; C089950:MF59 oil emulsion; D011136:Polysorbates; D014612:Vaccines; C478243:fluad vaccine; D013185:Squalene