A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients (NCT03629080) | Clinical Trial Compass
CompletedPhase 2
A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
United States83 participantsStarted 2018-12-12
Plain-language summary
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).
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of Participants With Adverse Events and Serious Adverse Events
Timeframe: 15 Months
2
Assessment of Humoral Immunogenicity Analyses
Timeframe: 15 Months
3
Number of Patients With Injection Site Events.
Timeframe: 15 Months
4
Change of Oral Body Temperature.
Timeframe: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months
5
Change of Respiration Rate.
Timeframe: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months.
6
Change of Blood Pressure.
Timeframe: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months
✕. 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.