Hookipa H-100-002
Research type
Research Study
Full title
A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)
IRAS ID
249002
Contact name
Mark Harber
Contact email
Sponsor organisation
Hookipa Biotech GmbH
Eudract number
2017-005407-32
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 11 months, 8 days
Research summary
This study involves the use of the investigational vaccine HB-101 in the prevention of cytomegalovirus (CMV) infection. There will be 2 groups of patients in this study who will receive different treatment regarding the use of anti-CMV anti-virals after kidney transplant:
Group 1: Patients will be followed pre-emptively after kidney transplant.
- Arm 1a: CMV negative patients awaiting kidney transplant from a CMV positive living donor to receive HB-101 before transplant and monitoring after transplant.
- Arm 1b: CMV negative patients awaiting kidney transplant from a CMV positive living donor to receive placebo before transplant and monitoring after transplant.Group 2: Patients will receive anti-viral prophylaxis
- Arm 2a: CMV negative patients awaiting kidney transplant from a CMV positive living donor to receive HB-101 and anti-viral medicine before transplant and monitoring after transplant.
- Arm 2b: CMV negative patients awaiting kidney transplant from a CMV positive living donor to receive placebo and anti-viral medicine before transplant and monitoring after transplant.The aims of the study are to assess the safety of HB-101 and to investigate whether HB-101 can produce common, "expected" side effects usually seen with vaccines (fever, sore arm at injection site). The HB-101 vaccine will be assessed for causing common immune system reactions in trial volunteers.
This clinical trial will be carried out on Adult volunteers who have negative blood results for CMV who are awaiting kidney transplant from a living donor who has positive blood results for CMV. Volunteers will be recruited from specified transplant centres around the world. Approximately 150 volunteers will take part.
Volunteers will complete and conclude the study when one of the following events first occurs:
- When the patient completes the study follow-up (12 months after transplant).
- If the kidney transplant has not happened by 12 months after the first dose of HB-101 or placebo.
- If the patient experiences transplant failure and has their kidney removed.
- If the patient withdraws or is withdrawn from the study.
- If the patient does not complete follow-up.
- If the patient dies.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/1290
Date of REC Opinion
30 Oct 2018
REC opinion
Further Information Favourable Opinion