Principal Investigator:  Dr Chris Hill

Name of the Study: A Randomised, Placebo-controlled Phase 2 study of HB-101, Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient 9R-) Patients Awaiting Kidney Transplantation from Living CMV – Seropositive Donors (D+)

Short name: Hookipa H-100-102

Why is this important? Cytomegalovirus is common in patients who have undergone solid organ transplantation. Majority of seronegative patients acquire primary infection from seropositive donor causing viraemia, which can result in end organ disease. Current treatments include antivirals but patients remain at significant risk of developing viraemia and late onset disease once treatment stopped. Other treatment plans required close monitoring necessitating frequent blood draws, which can have limited practical considerations. An effective CMV vaccine administrated pre transplant would overcome these limitations.

What is the Research question/aim?

A randomised placebo controlled phase 2 study of HB-101 a bivalent CMV Vaccine in CMV seronegative recipients (R-) patients awaiting kidney transplantation from living CMV –seronegative donors. Patients should have a living donor kidney transplantation ideally planned between 2-4 months after first injection of study drug (HB -101 or placebo)

What the Study involves:  Visits to the NICRF before and after transplant.

Who can take part in the Study?  Adult CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor.

Contact Information:

Principal Investigator: Dr Chris Hill

christopher.hill@belfasttrust.hscni.net

Study Coordinator: Sharon Carr, research nurse

sharon.carr@belfasttrust.hscni.net

02895040342

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