EUCTR2017-004322-15-BE进行中（未招募）1 期
An Open-label phase III study to investigate the safety, tolerability and immunogenicity of a nine-valent human papillomavirus (HPV) vaccine (Gardasil®9) in solid organ transplant recipients and HIV-infected patients
Z Leuven0 个研究点目标入组 310 人开始时间: 2017年12月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Independent Ethics Committee (IEC)-approved written informed consent form (ICF) must be obtained from the subject prior to any study-related procedures (including discontinuation of prohibited medication, if applicable) by the subject is given as required by local law.
- •2.Subject (man or woman) is between the age of 18 years and 0 days and 45 years and 365 days for HIV patients, between 18 years and 0 days and 55 years and 365 days for transplant patients at time of signing the ICF
- •3.Subject is able to understand and adhere to the study procedures (e.g., is not planning to relocate far from the investigational centre during the study period); is able to read, understand, and complete the vaccination diary; is able to understand the risks involved with the study; and voluntarily agrees to participate in the study by giving written informed consent.
- •4.* Since the first day of their last menstrual period through Day 1, female subjects have not had sex with males or has had sex with males and used effective contraception with no failures (an example of a failure is a male condom that ruptures during sexual intercourse). Effective contraception is defined as a marketed, approved contraceptive product that the subject has used per the manufacturer’s instructions with every act of sexual intercourse. The subject understands and agrees that during the Day 1 through Month 7 period, she should not have sexual intercourse with males without effective contraception. The use of the rhythm method alone, withdrawal alone, and emergency contraception, are not acceptable methods per the protocol. Subjects who have reached menopause, undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation are eligible without the use of contraceptives. Postmenopausal status is defined as: (1) No menses for >1 year but <3 years and confirmed by follicle stimulating hormone (FSH) levels elevated into the postmenopausal range, or (2) no menses for at least 3 years.
- •5.* Subject has had no temperature =37.8°C within 24 hours prior to the first injection.
- •6.Patient considerations
- •-HIV patients: have CD4+ T cell count of >200 cells/mm² at the last control (less than 16 months ago).
- •-SOT patients received their organ transplantation =12 months prior to vaccination and has been stable in the past 6 months (i.e. no acute rejection or other immunological reactions).
- •7.Apart from having HIV or received a solid organ transplant, the subject is in stable condition (i.e. no graft-versus-host disease or other immunological reactions) and is judged to be in good physical health on the basis of medical history, physical examination (if deemed necessary), and laboratory testing
- •8.Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
- •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 310
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subject has a history of an abnormal Pap test or abnormal cervical biopsy results (showing cervical intraepithelial neoplasia or worse) or cervical disease (i.e., surgical treatment for cervical lesions).
- •2.Subject has history of genital warts, Vulvar Intraepithelial Neoplasia or Vaginal Intraepithelial Neoplasia.
- •3.Subject has a history of a positive test for HPV.
- •4.Subject has a history of known prior vaccination with an HPV vaccine.
- •5.Subject is pregnant (as determined by serum or urine pregnancy test).
- •6.Subject is, at the time of signing ICF, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
- •7.Subject has a history of severe allergic reaction, including known allergy to any vaccine component, including aluminum, yeast, or BENZONASE® (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]) (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that met the criteria for serious adverse experiences defined in this protocol.
- •8.Patient’s condition
- •a.Exclusion criterion only for HIV patients: Subject has had a splenectomy, or has been diagnosed as having a congenital immunodeficiency, lymphoma, leukaemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune or immunosuppressive condition, or has a history of any disease, which, in the investigator’s opinion, may confound the results of the study or pose an additional risk to the subject.
- •b.Exclusion criterion only for SOT patients: Subject has had a splenectomy, or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune or immunosuppressive condition, or has a history of any disease, which, in the investigator’s opinion, may confound the results of the study or pose an additional risk to the subject.
- •9.Patient’s medication
- •a.Exclusion criterion only for HIV patients: Subject is receiving or has received in the year prior to enrolment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (tumour necrosis factor-a antagonists, monoclonal antibody therapies (including rituximab [Rituxan]), intravenous gamma globulin, antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrolment) received such therapy, or has received 2 or more courses of high dose corticosteroids (=20mg/day of prednisone [or equivalent] orally or parenterally) lasting at least 1 week in duration in the year prior to enrolment. Subjects using inhaled, nasal, or topical corticosteroids are considered eligible for the study
- •b.Exclusion criterion only for SOT patients: Subject is receiving or has received in the year prior to enrolment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (tumour necrosis
研究者
相似试验
进行中（未招募）
1 期
A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).Cystic FibrosisEUCTR2015-001997-16-GBVertex Pharmaceuticals Incorporated35
进行中（未招募）
1 期
A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).Cystic FibrosisEUCTR2015-001997-16-IEVertex Pharmaceuticals Incorporated35
进行中（未招募）
1 期
A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).Cystic FibrosisEUCTR2015-001997-16-DEVertex Pharmaceuticals Incorporated57
进行中（未招募）
1 期
Safety and Efficacy of AA4500 in combination with Erecaid Esteem Manual Vacuum Therapy System in men with Peyronie's DiseasePeyronie's DiseaseEUCTR2013-005384-66-GBEndo Ventures Limited30
进行中（未招募）
1 期
A study investigating the long-term safety and efficacy of intravenous (IV) ATB200 when Co-administrated with oral AT2221 in adult subjects with Pompe diseaseAdult Subjects With Late Onset Pompe Disease (LOPD)MedDRA version: 24.0Level: LLTClassification code 10075702Term: Pompe's disease late onsetSystem Organ Class: 100000004850EUCTR2019-000954-67-ITAMICUS THERAPEUTICS, INC.120