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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Germans Trias i Pujol Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Archivel Farma S.L.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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