EUCTR2005-004497-24-BE进行中（未招募）不适用
Observer-blinded, randomised, controlled, phase I/II study, to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis vaccines M72/AS01B and M72/AS02A when administered intramuscularly according to a vaccination schedule of 0, 1 month, to healthy PPD-negative adults aged 18 to 50 years. - TUBERCULOSIS-005,TUBERCULOSIS-006 EXT:005 Y1,TUBERCULOSIS-007 EXT:005 Y2,TUBERCULOSIS-008 EXT:005 Y3
适应症
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
- •A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject prior to any study procedure.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Subjects must have PPD negative skin reactivity (0 mm induration 48 to72 hours after PPD skin test administration).
- •Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis.
- •Seronegative for human immunodeficiency virus 1 and 2 (HIV 1/2) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies.
- •If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
- •No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray.
- •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
- •History of previous exposure to experimental products containing AS02A, AS01B or related products containing MPL and QS21.
- •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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, > = 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- •Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (nonsteroidal anti-inflammatory drugs e.g. aspirin, ibuprofen), and acetaminophen.
- •History of previous administration of experimental Mycobacterium tuberculosis vaccines
- •History of documented work related or close personal contact (same household) exposure to persons infected with Mycobacterium tuberculosis
- •Administration of any immunoglobulins, any immunotherapy and/or any blood products within the 3 months preceding the first dose of study vaccination, or planned administrations during the study period.
- •Participation in another experimental protocol during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
- •History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- •Volunteers with a personal history of autoimmune disease or who describe a first-degree relative with clearly documented autoimmune disease
- •History of any neurologic disorders or seizures.
- •History of chronic alcohol consumption and/or drug abuse.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions
研究者
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