Primary Objectives: 1. To assess the safety and reactogenicity of HB-101 2. To assess the immunogenicity of HB-101 Secondary Objectives: 1. To assess the efficacy of the administration of at least 2 doses of HB-101 compared to that of placebo in mitigating CMV DNAemia/viremia for patients followed by CMV preemptive therapy post-transplant 2. To assess the efficacy of the administration of at least 2 doses of HB-101 compared to that of placebo in decreasing the use of anti-virals at treatment dose for patients to be treated prophylactically for CMV post-transplant 3. To assess additional immunogenicity parameters of HB-101
This is a randomized, placebo-controlled, Phase 2 study of HB-101, a bivalent CMV vaccine, in CMV-seronegative recipient (R-) patients awaiting kidney transplantation from living CMV-seropositive donors (D+). The study population of the study is adult CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor, recruited globally from specified transplant centers.More
Inclusion Criteria 1. Male or female patients 18 years of age or older. 2. Patients must be CMV immunoglobulin G (IgG) seronegative (-) and will be receiving kidney for transplantation from donors who are CMV IgG seropositive (+). 3. Post-transplant CMV management will follow either preemptive treatment strategy (Group 1) or prophylactic anti-viral medication(s) (e.g., valganciclovir) per institutional standard of practice (Group 2). 4. Female patients of childbearing potential can participate in the study if they agree to use highly effective contraception. 5. Female patients must have a negative serum human chorionic gonadotropin (hCG) pregnancy test prior to each dose of study drug (HB-101 or placebo) or be surgically or biologically sterile or post-menopausal. 6. Male patients with sexual partners of childbearing potential can participate in the study if they agree to use barrier contraception from the time period between signing of the informed consent form and through 3 months after the last dose of study drug. 7. Male patients must agree to refrain from sperm donation from the time period between signing of the informed consent form and through 3 months after the last dose of study drug. 8. Patients who would comply with the requirements of this protocol (e.g., return for follow-up visits), as judged by the investigator. Exclusion Criteria 1. 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). 2. Patients planning to undergo multi-organ transplantation. 3. Previous vaccination with an investigational CMV vaccine. 4. Patients with known diagnosis of HIV. 5. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study. 6. Any Screening safety laboratory value of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 x upper limit of normal (ULN), total bilirubin >2 x ULN, absolute neutrophil count <500 cells/microL, or lymphocyte count <200 cells/microL. 7. Any confirmed or suspected immunodeficiency disorder that could interfere with the immune response or that presents a risk for the patient to receive a vaccine candidate in development. 8. Treatment with any chronic immunosuppressive medication or other immuno-modifying drugs within 6 months prior to study. However, inhaled and topical steroids and low-dose oral corticosteroids (< or equal to 10 mg a day of prednisone or equivalent) are allowed. 9. Prior history of CMV disease or CMV infection requiring anti-viral therapy. 10. Patients with a history of severe allergic reactions and/or anaphylaxis that could interfere with the immune response or that presents a risk for the patient to receive a vaccine candidate in development. 11. Patients with a severe coagulation abnormality that would preclude intramuscular injection. 12. Patients with a rash, dermatological condition, or tattoo in the area of the injection site(s) that could interfere with administration site reaction rating. 13. History or current evidence of medical disorders or conditions that could prevent the successful completion of the study, as judged by the investigator. 14. It is anticipated that the patient will be unavailable to complete the study follow-up. 15. Fever (> or equal to 38 degrees C) occurs within 7 days prior to first dose 16. For patients in the post-transplant CMV prophylactic therapy management group only, patients who will be receiving Cytogam in their post-transplant CMV prophylaxis regimen.
University of Colorado Hospital
Protocol Number: 18-1003
More information available at ClinicalTrials.gov: NCT03629080
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