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

May 14, 2009 updated by: Germans Trias i Pujol Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Badalona, Barcelona, Spain, 08916
        • Experimental Tuberculosis Unit. Fundació Institut per la Investigació Germans Trias i Pujol
      • Badalona, Barcelona, Spain, 08916
        • Pharmacology Department. Hospital Universitari Germans Trias i Pujol.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • 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: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • 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: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • 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: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • FCMtb is the active compound of the vaccine RUTI
Biological: RUTI
dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
Other Names:
  • 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 Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at protocol defined timepoints: days 0, 1, 3, 7, 21, 28, 29, 31, 35, 56
Occurrence, Intensity and Relationship to Vaccination of Local and Systemic Events
Time Frame: during the whole study
during the whole study
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
at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Collaborators

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"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 17, 2007

First Posted (ESTIMATE)

October 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2009

Last Update Submitted That Met QC Criteria

May 14, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FA/MI/01
  • EudraCT Number: 2006-000690-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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