A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
Condition: Cytomegalovirus (CMV) Infection; Kidney Transplantation
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 2

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).
    

Detailed description: 
      This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity,
      immunogenicity, and efficacy of HB-101 in adult patients awaiting kidney transplantation. For
      Groups 1 and 2, adult CMV-seronegative (-) patients awaiting kidney transplant from a
      CMV-seropositive (+) living donor will be enrolled according to treatment intent with regard
      to the method of CMV prevention after transplant (either preemptive or prophylactic). This
      will be defined at study enrollment by the investigator and institutional standards. Patients
      enrolled in Group 1 and 2 will be randomized to receive HB-101 or placebo. For Group 3, adult
      CMV-seropositive (+) patients awaiting kidney transplant from either CMV-seropositive(+) or
      CMV-seronegative(-) living donors will be enrolled. Group 3 will be open label where all
      patients will receive HB-101. The post transplant management for Group 3 patients will also
      follow either preemptive or prophylactic method per the institution standards. 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.
    

Intervention name(s): HB-101 vaccine; placebo
Intervention type(s): Biological; Biological
Intervention description(s): 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.
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)
Primary purpose: Prevention
Keywords: solid organ transplantation; vaccine