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Clinical Trial to Study 4 Different Doses of the Vaccine RUTI in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00546273
Recruitment Status : Completed
First Posted : October 18, 2007
Results First Posted : March 25, 2009
Last Update Posted : May 27, 2009
Sponsor:
Collaborator:
Archivel Farma S.L.
Information provided by:
Germans Trias i Pujol Hospital

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Latent Tuberculosis Infection Tuberculosis Biological: RUTI Biological: placebo of the vaccine RUTI Phase 1

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RUTI 5 micrograms of FCMtb
RUTI dose: 5 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
 Biological: RUTI
dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Name: FCMtb is the active compound of the vaccine RUTI
Experimental: RUTI 25 micrograms of FCMtb
RUTI dose: 25 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
 Biological: RUTI
dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Name: FCMtb is the active compound of the vaccine RUTI
Experimental: RUTI 100 micrograms of FCMtb
RUTI dose: 100 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
 Biological: RUTI
dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Name: FCMtb is the active compound of the vaccine RUTI
Experimental: RUTI 200 micrograms of FCMtb
RUTI 200 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)
 Biological: RUTI
dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Name: FCMtb is the active compound of the vaccine RUTI
Placebo Comparator: placebo
placebo of the vaccine RUTI (total n=8, n=2 for each period)
 Biological: placebo of the vaccine RUTI
placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point [ Time Frame: at protocol defined timepoints: days 0, 1, 3, 7, 21, 28, 29, 31, 35, 56 ]
  2. Occurrence, Intensity and Relationship to Vaccination of Local and Systemic Events [ Time Frame: during the whole study ]
  3. Number of Clinically Relevant Abnormalities in the Laboratory Tests According to the Doctors' Impression [ Time Frame: at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156 ]
    haematological and biochemical laboratory tests


Secondary Outcome Measures :
  1. Evaluation of the Immunogenicity of the Different Doses of the Vaccine Tested [ Time Frame: at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156 ]
    Immunological assays are performed at all timepoints to determine vaccine immunogenicity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546273


Locations
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Spain
Experimental Tuberculosis Unit. Fundació Institut per la Investigació Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Pharmacology Department. Hospital Universitari Germans Trias i Pujol.
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Archivel Farma S.L.
Investigators
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Principal Investigator: Pere-Joan Cardona, MD, PhD Unitat de Tuberculosi Experimental. Fundació Institut per la Investigació en Ciències de la Salut Germans Trias i Pujol.
Principal Investigator: Joan Costa, MD, PhD Pharmacology Department. Hospital Universitari "Germans Trias i Pujol"
More Information
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Additional Information:

Publications:

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Responsible Party: Pere-Joan Cardona, Fundacio Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier: NCT00546273    
Other Study ID Numbers: FA/MI/01
EudraCT Number: 2006-000690-29
First Posted: October 18, 2007    Key Record Dates
Results First Posted: March 25, 2009
Last Update Posted: May 27, 2009
Last Verified: May 2009
Keywords provided by Germans Trias i Pujol Hospital:
LTBI (Latent tuberculosis infection)
TB(Tuberculosis)
Vaccine
Additional relevant MeSH terms:
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Tuberculosis
Latent Tuberculosis
Infections
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Latent Infection
Vaccines
Immunologic Factors
Physiological Effects of Drugs