Double-Blind, Randomized, Placebo-Controlled Phase I Study, to Study the Tolerability and Immunogenicity of 4 RUTI Antituberculous Vaccine Different Doses (5, 25, 100 y 200µg of FCMtb) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point
研究概览
简要总结
The aim of this study is to evaluate the safety of a new vaccine against Tuberculosis (RUTI) when administered to healthy adult volunteers, compared to placebo; and determine its safe dosage range. An initial evaluation of immune responses to the vaccine compared to placebo will also be undertaken.
In the present Phase I clinical trial, four increasing doses of RUTI will be tested, the groups composed by 6 volunteers each. (Total of 24 volunteers). The escalation to a new dose to test will be done after the safety of the previous dose has been ensured.
For each dose of FCMtb to test, each volunteer will be inoculated twice (at day 0 and day 28) with RUTI (4 volunteers) or placebo (2 volunteers) and will be followed-up up to 25 weeks from the first inoculation. The global length of the study will be approximately 15 months.
详细描述
RUTI is a therapeutic vaccine made from virulent M.tuberculosis bacteria, grown in stressful conditions, fragmented, detoxified, heat inactivated (FCMtb) and liposomed. RUTI provides a strong humoral and cellular immune response against antigens from active growing and latent bacilli but also against structural antigens, as it has been proved in animal models of latent tuberculosis infection. The vaccine has been designed to be used against Latent Tuberculosis Infection as a therapeutic vaccine after 1-month of chemotheraputic treatment, instead the current treatment based on 6-9 months of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Healthy, based on medical examination at inclusion
- •Male Caucasian subjects, aged between 18 and 40 years
- •Willing and likely to be able to comply with the trial procedures
排除标准
- •Evidence of previous, current or latent tuberculosis, as radiological findings on chest X ray compatible with previous or current infection with tuberculosis
- •Positive T-SPOT TB result
- •BCG-vaccinated subjects
- •History of severe organ-system diseases, including
- •History of allergic disorders or known hypersensitivity to any drug or vaccine, or to any of the vaccine to be studied components
- •Personal or familiar history of autoimmune diseases, or Positive Antinuclear Antibodies
- •HIV, HBV and HCV sero-positive
- •Suspected or known current drug and/or alcohol abuse (as defined by an alcohol intake of > 50 g a day
- •Lost of more than 400 mL of blood within 12 weeks, or more than 250 mL within 4 weeks, before the recruitment
- •Laboratory parameters outside of normal ranges considered clinically significant
- •Intake of trial medication in other clinical trials within 1 month of the first vaccination
- •Intake of any other drugs that could not be eliminated of the body before the first vaccination, especially anti-inflammatory nonsteroid and corticosteroid drugs
- •Acute disease with > 37ºC temperature within 72 hours before the first vaccination
研究组 & 干预措施
placebo
placebo of the vaccine RUTI (total n=8, n=2 for each period)
干预措施: placebo of the vaccine RUTI (Biological)
RUTI 200 micrograms of FCMtb
RUTI 200 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
干预措施: RUTI (Biological)
RUTI 100 micrograms of FCMtb
RUTI dose: 100 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
干预措施: RUTI (Biological)
RUTI 25 micrograms of FCMtb
RUTI dose: 25 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
干预措施: RUTI (Biological)
RUTI 5 micrograms of FCMtb
RUTI dose: 5 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
干预措施: RUTI (Biological)
结局指标
主要结局
VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point
时间窗: at protocol defined timepoints: days 0, 1, 3, 7, 21, 28, 29, 31, 35, 56
Occurrence, Intensity and Relationship to Vaccination of Local and Systemic Events
时间窗: during the whole study
Number of Clinically Relevant Abnormalities in the Laboratory Tests According to the Doctors' Impression
时间窗: at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156
haematological and biochemical laboratory tests
次要结局
- Evaluation of the Immunogenicity of the Different Doses of the Vaccine Tested(at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156)