EUCTR2012-002541-37-BE进行中（未招募）1 期
A Phase II, open label, mono-centric study to evaluate the kinetics of mRNA expression after two doses of GSK Biologicals’ candidate tuberculosis (TB) vaccine GSK 692342 in healthy BCG-primed, HIV-negative adults aged 18-50 years when administered according to a 0, 1 month schedule. - TUBERCULOSIS-019
适应症
试验速览
- 阶段
- 1 期
- 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
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •A male or female between, and including, 18 and 50 years of age at the time of obtaining informed consent.
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Known BCG vaccination or presence of a BCG scar.
- •Seronegative for human immunodeficiency virus-1.
- •Female of non-childbearing potential may be enrolled in the study
- •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 screening and the day of first vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone (Inhaled and topical steroids are allowed).
- •Administration of long-acting immune-modifying drugs starting 2 years before the first dose and planned administration during the study.
- •Planned administration/administration of a vaccine/product not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending at the last study visit.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- •History of TB disease.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •QuantiFERON® TB Gold positive test result.
- •History of medically confirmed autoimmune disease.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •History of any reaction of hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
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