NCT02532036终止1 期
A Phase I Trial to Compare the Safety and Immunogenicity of Candidate TB Vaccine MVA85A Administered by the Aerosol Inhaled Route and the Intramuscular Route in Healthy Adult Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 8
- 主要终点
- Adverse Events (AE)
研究概览
简要总结
TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers must meet all of the following criteria to enter the trial:
- •Healthy adult aged 18-55 years
- •Resident in or near Oxford, Birmingham or London for the duration of the trial period
- •Screening IGRA positive
- •Ineligible for chemoprophylaxis for latent M.tb infection, declined prophylaxis or considered low risk due to distant contact history
- •Chest Computed Tomography (CT) normal; or abnormal with features consistent with primary M.tb infection but no features suggestive of active disease
- •No relevant findings in medical history or on physical examination
- •Allow the Investigators to discuss the individual's medical history with their General Practitioner
- •Use effective contraception for the duration of the trial period (females only)
- •Refrain from blood donation during the trial
- •Give written informed consent
- •Allow the Investigator to register volunteer details with a confidential database (The Over-volunteering Protection Service) to prevent concurrent entry into clinical trials
- •Able and willing (in the Investigator's opinion) to comply with all the trial requirements
排除标准
- •Volunteers must meet none of the following criteria to enter the trial:
- •Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the trial period
- •Prior vaccination with candidate vaccine MVA85A, candidate vaccine FP85A,any other recombinant MVA vaccine or any other candidate TB vaccine
- •Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
- •Clinically significant history of skin disorder, allergy, atopy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
- •Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
- •History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine, sedative drugs, or any local or general anaesthetic agents
- •Pregnancy, lactation or intention to become pregnant during trial period
- •Any respiratory disease, including asthma
- •Current smoker
- •Clinically significant abnormality on screening CT thorax
- •Clinically significant abnormality of pulmonary function tests
- •Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy
- •Current use of any medication taken through the nasal or inhaled route including cocaine or other recreational drugs
- •Clinical, radiological, or laboratory evidence of current active TB disease
- •Past treatment for TB disease
- •Any clinically significant abnormality of screening blood or urine tests
- •Positive HBsAg, HCV or HIV antibodies
- •Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the volunteer at risk, affect the volunteer's ability to participate in the trial or impair interpretation of the trial data
结局指标
主要结局
Adverse Events (AE)
时间窗: Up to Day 168
Actively and passively collected data on adverse events via diary card for 14 days after vaccination and at each visit over 6 months.
次要结局
- Laboratory Markers of Immunity(Up to Day 168)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
1 期
Safety of Tuberculosis Vaccine, MVA85A, Administered by the Intramuscular Route and the Intradermal RouteTuberculosisNCT01181856University of Oxford24
终止
1 期
Study of the Safety and Immunogenicity of an Adenovirus-based Tuberculosis VaccineTuberculosisNCT00800670McMaster University24
已完成
1 期
A Phase I Study to Assess the Safety and Immunogenicity of Tuberculosis (TB) Vaccine Candidates FP85A and MVA85ATuberculosisNCT00653770University of Oxford31
已完成
1 期
Safety of Tuberculosis Vaccine, MVA85A, Administered by the Aerosol Route and the Intradermal RouteTuberculosisNCT01497769University of Oxford24
已完成
1 期
Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIVTuberculosisHIV InfectionsNCT03141060National Institute of Allergy and Infectious Diseases (NIAID)37