Phase 1
N=6
Clinical Trial to Study 4 Different Doses of the Vaccine RUTI in Healthy Volunteers
Latent Tuberculosis Infection · Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT00546273 ↗Enrolled (actual)
6
Serious AEs
—
Results posted
Mar 2009
Primary outcome: Primary: VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RUTI (Biological); placebo of the vaccine RUTI (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Germans Trias i Pujol Hospital
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point |
— | — |
| PRIMARY Occurrence, Intensity and Relationship to Vaccination of Local and Systemic Events |
— | — |
| PRIMARY Number of Clinically Relevant Abnormalities in the Laboratory Tests According to the Doctors' Impression |
0; 0; 0; 0; 0 | — |
| SECONDARY Evaluation of the Immunogenicity of the Different Doses of the Vaccine Tested |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00546273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.