A clinical trial to test a new vaccine, in avoiding cytomegalovirus (CMV) infection after transplant, if you have never encountered the virus and your donor may harbor it.
- Conditions
- Prevention of clinically significant cytomegalovirus (CMV) infectionMedDRA version: 21.1Level: PTClassification code 10072247Term: Cytomegalovirus immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2017-005047-32-DE
- Lead Sponsor
- Hookipa Biotech GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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. 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.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 (Group2).
6. 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.
7. 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 <=50 years with 6 months of spontaneous amenorrhea and follicle-stimulating hormone level within post-menopausal range (>40 mIU/mL).
• Permanently sterilized women (hysterectomy or bilateral oophorectomy).
8. 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.
9. 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.
10. Patients who would comply with the requirements of this protocol
(e.g., return for follow up visits), as judged by the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of
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 <500 cells/µL, or lymphocyte count <200 cells/µL.
8. 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.
9. Treatment with any chronic immunosuppressive medication or other immuno modifying drugs within 6 months prior to study entry (unless agreed otherwise between the sponsor and investigator on a case-by-case basis). However, inhaled and topical steroids and low-dose oral corticosteroids (=10 mg a day of prednisone or equivalent) are allowed.
10. Prior history of CMV disease or CMV infection requiring anti-viral therapy.
11. Patients with a history of severe allergic reactions and/or anaphylaxis that could interfere with the immune response (including an
allergy or hypersensitivity to any ingredient found in the study drug [HB101 or placebo]) or that presents a risk for the patient to receive a vaccine candidate in development.
12. Patients with a severe coagulation abnormality that would preclude intramuscular injection.
13. 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).
14. History or current evidence of medical disorders or conditions that could prevent the successful completion of the study, as judged by the investigator.
15. It is anticipated that the patient will be unavailable to complete study follow-up.
16. Fever (>= 38°C) occurs within 7 days prior to first dose (unless agreed otherwise between the sponsor and investigator on a case-by-case basis).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method