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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cytomegalovirus (CMV) Infection, Kidney Transplantation

In brief

HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study 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 and CMV-Seropositive patients.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).

Key facts

Study ID

NCT03629080

Run by

Hookipa Biotech GmbH

People needed

83

Starts

2018-12-12

Expected to finish

2022-06-22

Last updated by the study team

2023-10-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who meet all of the following key inclusion criteria will be eligible to participate in the study:
• Male or female patients 18 years of age or older.
• Patients must be eligible to undergo kidney transplantation from a living donor as per institutional standards.
• For Groups 1 and 2 only: Patients must be CMV immunoglobulin G (IgG) seronegative (-) and receiving kidney for transplantation from donors who are CMV IgG seropositive (+).
• For Group 3 only: Patients must be CMV immunoglobulin G (IgG) seropositive (+) and receiving kidney for transplantation from donors who are either CMV IgG seronegative (-) or seropositive (+).
• Patients who would comply with the requirements of this protocol (e.g., return for follow up visits), as judged by the investigator.

You may not qualify if…

• Patients who meet any of the following key criteria will be excluded from the study:
• Patients planning to undergo multi-organ transplantation.
• Patients participating in another interventional clinical study.
• Previous vaccination with an investigational CMV vaccine.
• Any confirmed or suspected immunodeficiency disorder (based on medical history and physical examination) that could interfere with the immune response or that presents a risk for the patient to receive a vaccine candidate in development.
• Treatment with any chronic immunosuppressive medication or other immuno modifying drugs within 6 months prior to study entry. However, inhaled and topical steroids and low-dose oral corticosteroids (<10 milligrams a day of prednisone or equivalent) are allowed.
• Prior history of CMV disease or CMV infection requiring anti-viral therapy
• Patients with a rash, dermatological condition, or tattoo in the area of the injection site(s) that could interfere with administration site reaction rating. (Note: The injection site(s) can be the non-dominant arm [most preferred injection site], dominant arm, or either thigh [least preferred injection site], as judged by the investigator).
• It is anticipated that the patient will be unavailable to complete the study follow-up.
• Patients who are highly sensitized or who are likely to undergo desensitization at time of transplant (e.g., donor-specific antibody titers at the local laboratory >2000).

Where it is running

• The 1917 Clinic at UAB — Birmingham, Alabama, United States
• California Institute of Renal Research — La Mesa, California, United States
• UC Davis Health Systems — Sacramento, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Indiana University/IU Health — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• University of Cincinnati (UC) - College of Medicine — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Oklahoma University — Oklahoma City, Oklahoma, United States
• Thomas E. Starzl Transplantation Institute — Pittsburgh, Pennsylvania, United States
• South Texas Accelerated Research — Dallas, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States
• Odense University Hospital — Odense, Denmark
• Centre Hospitalier Universitaire de Bordeaux Hôpital Pellegrin — Bordeaux, France
• Hopital Necker-Enfants Malades — Paris, France
• CHU de Toulouse - Hospital Rangueil — Toulouse, France
• Charite Universitatsmedizin Berlin — Berlin, Germany
• Universitatsklinikum Essen — Essen, Germany
• Oslo University Hospital — Oslo, Norway
• Belfast Health and Social Care Trust — Belfast, United Kingdom
• Cardiff & Vale University Health Board — Cardiff, United Kingdom
• St James's University Hospital — Leeds, United Kingdom
• Leicester General Hospital — Leicester, United Kingdom
• The Royal Free Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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