Cytomegalovirus infection
Conditions
Interventions
There will be 2 groups stratified by treatment intent (as per the investigator
and institutional standards) regarding the use of anti-CMV anti-virals
post-transplantation. Each group will be randomi
Sponsors
Hookipa Biotech AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: English 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 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 preemptive treatment strategy (Group 1) or prophylactic anti-viral medication(s) (e.g., valganciclovir) per institutional standard of practice (Group 2). 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. • 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 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 the last dose of study drug. 11. Patients who would comply with the requirements of this protocol
Exclusion criteria
Exclusion criteria: English 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. 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 in 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 |
|---|---|
| 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: (HB-101 versus placebo) and 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Additional immunogenicity parameters of HB-101 will be assessed using descriptive central statistics presented by treatment group for Group 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: 6.LCMV neutralizing antibody 7.CMV ICS pp65 8.CMV ICS gB 9.LCMV ELISPOT NP | — |
Countries
Netherlands
Outcome results
None listed