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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 99
Updated:3/1/2019
Start Date:December 12, 2018
End Date:January 15, 2021
Contact:General Hookipa contact
Email:office@hookipabiotech.com
Phone:+43 1 890 6360

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A Randomized, Placebo-Control, 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+).

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).

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.

Inclusion Criteria:

Patients who meet all of the following inclusion criteria will be eligible to participate
in the study:

1. Male or female patients 18 years of age or older.

2. Patients must be eligible to undergo kidney transplantation from a living donor as per
institutional standards.

3. Patients must be CMV immunoglobulin G (IgG) seronegative (-) and receiving kidney for
transplantation from donors who are CMV IgG seropositive (+).

4. Patients who would comply with the requirements of this protocol (e.g., return for
follow up visits), as judged by the investigator.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

1. Patients planning to undergo multi-organ transplantation.

2. Patients participating in another interventional clinical study.

3. Previous vaccination with an investigational CMV vaccine.

4. 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.

5. 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.

6. Prior history of CMV disease or CMV infection requiring anti-viral therapy

7. 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).

8. It is anticipated that the patient will be unavailable to complete the study
follow-up.
We found this trial at
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sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-9673
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Phone: 720-848-2277
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Brussels,
Principal Investigator: Eric Goffin
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Rita Alloway
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Cincinnati, Ohio 45267
Principal Investigator: Rita Alloway
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La Mesa, California 91942
Principal Investigator: Arman Faravardeh
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Phone: 415-600-1092
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Phone: 206-386-3660
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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