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 States, Denmark, France83 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 range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.