A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
Condition: Cytomegalovirus (CMV) Infection; Kidney Transplantation
MeSH terms: Cytomegalovirus Infections
Intervention: HB-101 vaccine; placebo
Intervention description: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV.; Saline will be used for placebo.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This phase 2 study will be conducted in three groups stratified by treatment intent. In Group 1, patients will be randomized to receive HB-101 (1a) or placebo (1b) and followed preemptively post-transplant. Approximately 50 patients will be randomized in Group 1. In Group 2, patients will be randomized to receive HB-101 (2a) or placebo (2b) before transplant. Post-transplant patients will receive 3-6 months of anti-viral prophylaxis following institutional standards. Approximately 100 patients will be randomized in Group 2. In Group 3, all patients will receive HB-101 (open label) vaccination(s) prior to their transplant surgery. Post-transplant CMV management will follow either preemptive or prophylactic care as defined at study enrollment by the investigator and institutional standards. Approximately 25 patients will be randomized in Group 3.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The participants, investigators and care providers (study site personnel) will be blinded.
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: solid organ transplantation; vaccine

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).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who meet all of the following key 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. 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 (+).

          4. 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 (+).

          5. 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 key 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.

          9. 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).