NL-OMON48943撤回2 期
A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+) - Hookipa
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 22
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •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,
- •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 <=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).
- •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
- 另有 3 项未显示
排除标准
- •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 <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 milligrams a day of prednisone or equivalent) are allowed.
- •10. For Groups 1 and 2 only, patients with prior history of CMV disease or CMV
- •infection requiring anti-viral therapy.
- •11. For Group 3 only, patients with active CMV infection requiring antiviral
- •therapy within 30 days prior to the first injection of study drug.
- •12. 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.
- •13. Patients with a severe coagulation abnormality that would preclude
- •intramuscular injection.
- •14. 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).
- •15. History or current evidence of medical disorders or conditions that could
- •prevent the successful completion of the study, as judged by the investigator.
- •16. It is anticipated that the patient will be unavailable to complete study
- •follow-up.
- •17. 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).
- •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.
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