Last updated on April 2019

A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients

Brief description of study

HB-101 is a bivalent recombinant vaccine against human CMV infection. In this phase 2 study, adult CMV-Seronegative patients awaiting kidney transplant from a CMV-Seropositive living donor will be enrolled into 1 of 2 treatment arms according to treatment intent (HB-101 or placebo) with regard to the method of CMV prevention after transplant (either preemptive or with an anti-viral prophylaxis). Patients enrolled should have a living donor kidney transplantation ideally planned between two to four months after the first injection of study drug (HB-101 or placebo).

Detailed Study Description

This is a randomized, placebo-controlled, phase 2 study is to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative patients receiving a kidney transplant from a CMV-Seropositive living donor. The intent of the study is to administer three doses of the study drug (HB-101 or placebo) prior to transplantation and within proximity to the time of transplantation. However, two doses of study drug will be sufficient for the patients to be included in the efficacy analyses if a third dose of study drug is not feasible due to transplantation timelines. Patients will not receive study drug after transplantation. Patients will be recruited globally from transplant centers. The total duration of the study of each patient participating in the study will be approximately 15 months.

Clinical Study Identifier: NCT03629080

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