EUCTR2009-012223-29-BE进行中（未招募）不适用
A phase II, open, single centre, exploratory study to evaluate the safety and immunogenicity of one booster dose of a GSK Biologicals’ Hepatitis B vaccine Engerix™-B or a of GSK Biologicals’ HIV candidate vaccine (732461), administered intramuscularly, in conjunction with the administration of a single oral dose of chloroquine in healthy adults. - EARLY-CLINRES-004
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •ALL subjects must satisfy ALL the following criteria at study entry:
- •A male or female between, and including, 18 to 52 years of age at the time of vaccination.
- •Written informed consent prior to any study related procedure on the subject.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards and return for follow-up visits).
- •Good general health without significant medical history or physical examination findings.
- •Negative for anti-HBc and anti-Hepatitis C Virus (HCV) antibodies.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception until study completion.
- •In addition, subjects from the TH-ADJ-005 (287615) study willing to participate in this study must satisfy ALL the following criteria at study entry:
- •Previous participation and completion of the TH-ADJ-005 (287615) study.
- •CD4+-responder to HBsAg from the AS01B, AS02B or AS02V groups of the TH-ADJ-005 (287615) study.
- •In addition, subjects from the PRO-HIV-005 (108706) study willing to participate in this study must satisfy ALL the following criteria at study entry:
- •Previous participation and completion of the PRO-HIV-005 (108706) study.
- •CD4+-responder from the 10µg or the 30µg groups of the PRO-HIV-005 (108706) study.
- •Subjects must be willing to accept HIV test results. Individuals who elect not to receive test results will not be enrolled.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- •For ALL subjects:
- •Clinically significant laboratory value above normal range for Blood Urea Nitrogen, Creatinine, Alanine aminotransferase and Aspartate aminotransferase, or clinically significant laboratory value above or below normal range for Hemoglobin, as per investigator judgment.
- •Women who are pregnant or breast-feeding.
- •Receipt of live attenuated vaccines within 30 days of vaccination.
- •Receipt of medically indicated subunit or killed vaccines or allergy treatment with antigen injections within 14 days of study vaccine administration.
- •Receipt of blood products 120 days prior to vaccination.
- •Receipt of immunoglobulin 120 days prior to vaccination.
- •Subject has donated blood in the last 3 months.
- •Bleeding disorder that was diagnosed by a physician; e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions (a subject who states that he or she has easy bruising or bleeding, but does not carry a formal diagnosis and has intramuscular injections and blood drawn without any adverse experience is eligible).
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination (for corticosteroids, this will mean prednisone from 10 milligram/day, or equivalent). Inhaled and topical steroids are allowed.
- •History of serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product.
- •History of serious allergic reaction to any substance requiring hospitalization or emergency medical care (e.g., Steven-Johnson syndrome, bronchospasm, or hypotension).
- •History of hypersensitivity against chloroquine or any components of the drug.
- •History of hypersensitivity against aminoglycosides.
- •Ophthalmologic findings at screening (namely maculopathy, retinopathy, corneal opacities and cataracts).
- •Previous administration of 4-aminoquinoline in the previous year or for a duration of more than 1 year.
- •History of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
- •History of hematopoietic disease.
- •History of Myasthenia gravis.
- •History of any serious neurological disorder or seizure.
- •History of immunodeficiency or immune-mediated disorders, including active psoriasis.
- •History of type I or type II diabetes mellitus including cases controlled with diet alone (a subject with past gestational diabetes is eligible).
- •Thyroid disease including history of thyroidectomy and diagnoses requiring medication (a subject not requiring thyroid medicine within the past 12 months is eligible).
- •Asthma requiring daily steroid or long acting beta-agonist prevention.
- •Unstable asthma defined as:
- •Sudden acute attacks occurring in less than three hours without an obvious trigger.
- •Hospitalization for asthma in the last two years.
- •Food- or wine-induced asthma.
- •Known sensitivity to sulfites or aspirin.
- •History of major congenital defect.
- •History of chronic fatigue syndrome or fibromyalgia.
- •History of malignancy (unless there has been surgical excision followed by a sufficient observation period, of at least 5 years, to give a reasonable assurance of sustained cure and
研究者
相似试验
进行中（未招募）
不适用
A phase II, controlled, single centre, open study to evaluate the safety, reactogenicity and immunogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with a reduced dose of AS03, compared to a second dose of Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects 18-60 years previously vaccinated in FLU-LD-004 clinical trial. - FLU-LD-010 EXT: 004 Y1EUCTR2007-002783-10-BEGlaxoSmithKline Biologicals300
尚未招募
2 期
A phase II, open, single arm, single center study to evaluate the efficacy and safety of compound Huangdai tablets for advanced liver cancerprimary liver cancerITMCTR2100005192Changhai Hospital, Navy Military Medical University, Shanghai
进行中（未招募）
不适用
A Phase II single centre, open-label study investigating the pharmacokinetics, pharmacodynamics, efficacy and safety of a loading dose regimen of a new GnRH antagonist, Teverelix, long-acting formulation administered subcutaneously as two doses of 120 mg in patients with advanced prostate cancerEUCTR2005-002100-42-LTArdana Bioscience Ltd8
进行中（未招募）
不适用
A Phase II single centre, open-label study investigating the pharmacokinetics, pharmacodynamics, efficacy and safety of a loading dose regimen of a new GnRH antagonist, Teverelix, long-acting formulation administered subcutaneously as two doses of 120 mg (given as 2 injections of 60 mg on Day 1 and repeated on Day 2) in patients with advanced prostate cancerADVANCED PROSTATE CANCEREUCTR2005-005742-39-LTArdana Bioscience Ltd8
进行中（未招募）
2 期
An open label, single centre, phase II pilot study of neoadjuvant dabrafenib + trametinib in patients with resectable AJCC Stage IIIB-C BRAF V600 mutation positive melanomaCancer - Malignant melanomaMelanomaACTRN12613000737730Melanoma Institute Australia35