Prevention of clinically significant cytomegalovirus (CMV) infection MedDRA version: 21.1 Level: PT Classification code 10072247 Term: Cytomegalovirus immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Code: HB-101
Pharmaceutical Form: Solution for injection
INN or Proposed INN: rLCMV vector (HK1) encoding human CMV phosphoprotein 65 kD (Hpp65)
Current Sponsor code: HK1-HPP65
Other descripti
Sponsors
Hookipa Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients 18 years of age or older. 2. Patients willing and able to give written informed consent for participation in the study. 3. Patients must be eligible to undergo kidney transplantation from a living donor as per institutional standards. 4. For Group 1 and 2, patients must be CMV immunoglobulin G (IgG) seronegative (-) and will be receiving a kidney for transplantation from donors who are CMV IgG seropositive (+). (If CMV IgG serology is indeterminate, repeat testing is recommended. If the serology for the donor is indeterminate upon repeat testing, it should be considered positive; if the serology for the recipient is indeterminate upon repeat testing, it should be considered negative). 5. For Group 3, patients must be CMV IgG seropositive (+) and will be receiving a kidney for transplantation from donors who are CMV IgG seropositive (+) or CMV IgG seronegative ( ). Group 3 patients must have documentation of a planned transplant that is scheduled to occur between 2 and 4 months after the first study drug injection. 6. Post-transplant CMV management will follow either a preemptive treatment strategy or prophylactic anti-viral medication(s) (e.g., valganciclovir) per institutional standard of practice. 7. Female patients of childbearing potential can participate in the study if they agree to use highly effective contraception. This applies from the time period between signing of the informed consent form and up to 12 months after the last study drug (HB-101 or placebo) injection or up to completion of the study, whichever is longer. Highly effective contraception methods include: • Total abstinence. Abstinence is acceptable only when this is in line with the preferred and usual lifestyle of the patient (e.g., true abstinence). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. • Male or female sterilization. • Combination of any 2 of the following categories (Categories 1+2, 1+3, or 2+3): o Category 1: Use of oral, injected, or implanted hormonal methods of contraception. o Category 2: Placement of an intrauterine device or intrauterine system. o Category 3: Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. 8. Female patients must have a negative serum human chorionic gonadotropin pregnancy test prior to each dose of study drug (HB-101 or placebo), unless the pregnancy test is deemed a false positive and clinical evidence is negative for pregnancy after discussion between the sponsor and investigator on a case-by-case basis; or be surgically or biologically sterile or post menopausal. Post-menopausal females are defined as: • Age >50 years with amenorrhea for at least 12 months. • Age 40 mIU/mL). • Permanently sterilized women (hysterectomy or bilateral oophorectomy). 9. 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. 10. 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 t
Exclusion criteria
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). Only patients with no risk or low risk of sensitization defined in the study protocol should be enrolled, owing to tolerance against the relevant HLA epitopes. 2. Patients planning to undergo multi-organ transplantation. 3. Patients participating in another interventional clinical study. 4. Previous vaccination with an investigational CMV vaccine. 5. Patients with known diagnosis of human immunodeficiency virus. 6. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study. 7. 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 = 38°C) occurs within 7 days prior to first dose (unless agreed otherwise between the sponsor and investigator on a case-by-case basis). 18.For patients receiving the post-transplant CMV prophylactic therapy management group only, patients who will be receiving Cytogam® in their post-transplant CMV prophylaxis regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To assess the safety and reactogenicity of HB-101. 2.To assess the immunogenicity of HB-101. ;Secondary Objective: 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 CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and 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 CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and to be treated prophylactically for CMV post transplant. 3.To assess the efficacy of the administration of at least 2 doses of HB-101 in CMV seropositive (+) recipients awaiting kidney transplant and followed by CMV post transplant preemptive management or prophylactic anti-viral therapy.;Primary end point(s): Safety and reactogenicity of HB-101 will be assessed by treatment group (for Groups 1 and 2 and open-label HB-101 for Group 3) and by number of vaccinations: 1.Incidence and severity of AEs, SAEs, and changes in laboratory values 2.Incidence and severity of localized or generalized injection site reactions The immunogenicity of HB-101 will be assessed using descriptive central statistics presented by treatment group (for Groups 1 and 2 and open-label HB-101 for Group 3) and by post-transplant CMV management strategy (prevention or preemption) for the following immunogenicity parameters: 3.CMV neut 4.CMV ELISPOT pp65 5.CMV ELISPOT gB ;Timepoint(s) of evaluation of this end point: 1.From the time of the first injection of study drug (HB-101 or placebo) up through 30 days after the last injection of study drug. From 31 days after the last injection of study drug up through the End of Study Visit. After transplant up to the End of the Study Visit. Through the study Until re | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Incidence and time to clinically significant CMV infection, CMV disease, and CMV syndrome 2.Incidence and time to CMV viremia requiring anti viral therapy 3.Incidence and duration (in days) of anti-CMV therapy courses (at therapeutic doses) required 4.Incidence and time to quantifiable CMV DNAemia, peak CMV DNAemia level, and duration of CMV DNAemia above the limit of quantitation 5.Incidence and time to graft failure and organ rejection.;Timepoint(s) of evaluation of this end point: 1., 2., 3., 4. and 5.Through 12 months after transplant. | — |
Countries
Austria, Belgium, Denmark, France, Germany, Netherlands, Norway, United Kingdom, United States
Contacts
Public ContactGeneral Contact
Hookipa Biotech GmbH
Outcome results
None listed