Clinical Trial to Study 4 Different Doses of the Vaccine RUTI in Healthy Volunteers
NCT ID: NCT00546273
Last Updated: 2009-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2007-04-30
2008-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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RUTI 5 micrograms of FCMtb
RUTI dose: 5 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
RUTI
dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
RUTI 25 micrograms of FCMtb
RUTI dose: 25 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
RUTI
dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
RUTI 100 micrograms of FCMtb
RUTI dose: 100 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
RUTI
dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
RUTI 200 micrograms of FCMtb
RUTI 200 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
RUTI
dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
placebo
placebo of the vaccine RUTI (total n=8, n=2 for each period)
placebo of the vaccine RUTI
placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28
Interventions
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RUTI
dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
RUTI
dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
RUTI
dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
RUTI
dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
placebo of the vaccine RUTI
placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
MALE
Yes
Sponsors
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Archivel Farma S.L.
INDUSTRY
Germans Trias i Pujol Hospital
OTHER
Responsible Party
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Fundacio Institut Germans Trias i Pujol
Principal Investigators
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Pere-Joan Cardona, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Unitat de Tuberculosi Experimental. Fundació Institut per la Investigació en Ciències de la Salut Germans Trias i Pujol.
Joan Costa, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Pharmacology Department. Hospital Universitari "Germans Trias i Pujol"
Locations
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Experimental Tuberculosis Unit. Fundació Institut per la Investigació Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Pharmacology Department. Hospital Universitari Germans Trias i Pujol.
Badalona, Barcelona, Spain
Countries
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References
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Cardona PJ, Amat I, Gordillo S, Arcos V, Guirado E, Diaz J, Vilaplana C, Tapia G, Ausina V. Immunotherapy with fragmented Mycobacterium tuberculosis cells increases the effectiveness of chemotherapy against a chronical infection in a murine model of tuberculosis. Vaccine. 2005 Feb 3;23(11):1393-8. doi: 10.1016/j.vaccine.2004.09.008.
Cardona PJ, Amat I. [Origin and development of RUTI, a new therapeutic vaccine against Mycobacterium tuberculosis infection]. Arch Bronconeumol. 2006 Jan;42(1):25-32. doi: 10.1016/s1579-2129(06)60110-9. Spanish.
Cardona PJ. RUTI: a new chance to shorten the treatment of latent tuberculosis infection. Tuberculosis (Edinb). 2006 May-Jul;86(3-4):273-89. doi: 10.1016/j.tube.2006.01.024. Epub 2006 Mar 20.
Vilaplana C, Ruiz-Manzano J, Gil O, Cuchillo F, Montane E, Singh M, Spallek R, Ausina V, Cardona PJ. The tuberculin skin test increases the responses measured by T cell interferon-gamma release assays. Scand J Immunol. 2008 Jun;67(6):610-7. doi: 10.1111/j.1365-3083.2008.02103.x. Epub 2008 Apr 4.
Guirado E, Gil O, Caceres N, Singh M, Vilaplana C, Cardona PJ. Induction of a specific strong polyantigenic cellular immune response after short-term chemotherapy controls bacillary reactivation in murine and guinea pig experimental models of tuberculosis. Clin Vaccine Immunol. 2008 Aug;15(8):1229-37. doi: 10.1128/CVI.00094-08. Epub 2008 Jun 4.
Gil O, Vilaplana C, Guirado E, Diaz J, Caceres N, Singh M, Cardona PJ. Enhanced gamma interferon responses of mouse spleen cells following immunotherapy for tuberculosis relapse. Clin Vaccine Immunol. 2008 Nov;15(11):1742-4. doi: 10.1128/CVI.00255-08. Epub 2008 Sep 30.
Related Links
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Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol homepage
Other Identifiers
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EudraCT Number: 2006-000690-29
Identifier Type: -
Identifier Source: secondary_id
FA/MI/01
Identifier Type: -
Identifier Source: org_study_id
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