Randomized Controlled Trial of Adjuvanted Versus Nonadjuvanted Influenza Vaccine in Kidney Transplant Recipients.
Kumar D, Campbell P, et al.Transplantation 2015 [record in progress].
Aims
To compare adjuvanted versus a nonadjuvanted vaccine in stable outpatient kidney transplant recipients of both the indicated population age (≥65 years) and those aged 18-64 years
Interventions
Patients were randomised to receive either adjuvanted (Fluad containing 15 μg antigen of each strain in 0.5 mL volume and MF59 adjuvant) or nonadjuvanted (Agriflu with the same amount of antigen and volume but without MF59) seasonal influenza vaccine.
Participants
68 adult kidney recipients ≥ 3 months after transplantation attending outpatient clinicis and not yet received the 2012-2013 influenza vaccine
Outcomes
The primary outcome was vaccine immunogenicity, measured by seroconversion to at least 1 of 3 influenza vaccine antigens.
Follow-up
6 months
CET Conclusions
In this small but well done study stable patients with a kidney transplant during the Fall of 2012 were vaccinated with a standard influenza vaccine or with a vaccine with an added adjuvant. Seroconversion was equivalent in both arms in the age group between 18 and 64, although with a trend to be higher in the patients who received the antigen with adjuvant. There were no safety issues and, in particular, there was no change in HLA antibody status. However, it was noted that seroconversion was less likely in patients on MMF, particularly higher doses. Thus, the conclusion was that the influenza vaccine with adjuvant did not make the vaccine more immunogenic.
Data analysis
Available case analysis
Trial registration
Clinicaltrials.gov - NCT01584908