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

This study has been completed.
Sponsor:
Collaborator:
Archivel Farma S.L.
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00546273
First received: October 16, 2007
Last updated: May 14, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Latent Tuberculosis Infection
Tuberculosis
Biological: RUTI
Biological: placebo of the vaccine RUTI
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Occurrence, Intensity and Relationship to Vaccination of Local and Systemic Events [ Time Frame: during the whole study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546273

Locations
Spain
Pharmacology Department. Hospital Universitari Germans Trias i Pujol.
Badalona, Barcelona, Spain, 08916
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
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Archivel Farma S.L.
Investigators
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

Additional Information:
Publications:
Responsible Party: Pere-Joan Cardona, Fundacio Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier: NCT00546273     History of Changes
Other Study ID Numbers: FA/MI/01, EudraCT Number: 2006-000690-29
Study First Received: October 16, 2007
Results First Received: October 31, 2008
Last Updated: May 14, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Germans Trias i Pujol Hospital:
LTBI (Latent tuberculosis infection)
TB(Tuberculosis)
Vaccine

Additional relevant MeSH terms:
Infection
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 19, 2014