Clinical Trial to Study 4 Different Doses of the Vaccine RUTI in Healthy Volunteers
Condition: Latent Tuberculosis Infection; Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Intervention: RUTI; RUTI; RUTI; RUTI; placebo of the vaccine RUTI
Intervention description: dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28; dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28; dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28; dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28; placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: LTBI (Latent tuberculosis infection); TB(Tuberculosis); Vaccine

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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