A Randomized, Placebo-Controlled Phase I Trial of Live, Attenuated Herpes Zoster Vaccine in Subjects with End Stage Renal Disease Immunized Prior to Renal Transplantation.Miller G, Schaefer H, et al.
Transplant Infectious Disease 2018; 20(3): e12874.
To assess the safety of a shingles vaccine administered to adult renal transplant recipients prior to transplantation.
Participants were randomised to receive either vaccine or placebo, and were vaccinated no less than 4 weeks prior to transplantation.
34 Chronic kidney disease subjects awaiting renal transplant, aged ≥ 18 years and seropositivity for prior varicella zoster virus (VZV) infection.
Primary measured outcomes included the incidence of ≥ Grade 3 vaccine-related adverse events, serious adverse events (SAEs), vaccine-related SAEs, proven vaccine strain VZV infection, increase of calculated panel reactive antibody by ≥10% or newly positive donor-specific cross match prior to transplantation, and biopsy proven rejection. The secondary measured outcome was the change from baseline glycoprotein ELISA for VZV-specific IgG antibodies VZV antibody titer.
This small pilot study investigates the role of a live, attenuated shingles vaccine in patients with end-stage renal disease awaiting transplant. 34 patients were randomised 3:1 to vaccine or placebo, and safety and efficacy were assessed. The vaccine appears safe and well-tolerated, and in this small sample there was no difference in DSA or PRA after vaccination. Antibody titres showed a rise consistent with protection. As shingles is more common in immunosuppressed patients than the general population, and the incidence of complications such as post-herpetic neuralgia is common, these results are promising. A larger study with longer follow-up will be required to confirm safety and clinical efficacy, and to determine the optimum timing of vaccination relative to placing patients on the waiting list.
Clinicaltrials.gov - NCT01137669