Transplant Trial Watch

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.

12 months

CET Conclusions
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.

Jadad score

Data analysis
Per protocol analysis

Allocation concealment

Trial registration - NCT01137669

Funding source
Non-industry funded