Tolerability and Immunogenicity of Tuberculosis (RUTI) Antituberculous Vaccine in Healthy Volunteers, Phase I Clinical Trial - Full Text View

Sponsors and Collaborators:	Germans Trias i Pujol Hospital Archivel Farma S.L.
Information provided by:	Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:	NCT00546273

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.

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 chemotherapic treatment, instead the current treatment based on 6-9 months of chemotherapy.

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 escalate to a new dose to test will be done after the safety of the previous dose had 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 Vaccine	Biological: RUTI	Phase I

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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.

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

Primary Outcome Measures:

To evaluate the safety profile and determine a safe dosage range of a new therapeutic vaccine against TB (RUTI).Four different doses will be tested, given as two s.c. inoculations with 28 days interval. [ Time Frame: 12 months, 6 months follow-up for each volunteer ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the immunogenicity of a new therapeutic vaccine against TB (RUTI). Four different doses will be tested, given as two s.c. inoculations with 28 days interval. [ Time Frame: Time Frame: 12 months, 6 months follow-up for each volunteer ] [ 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
I RUTI administered twice 4 weeks apart to 4 volunteers, and placebo administered twice 4 weeks apart to other 2.	Biological: RUTI 5 micrograms of FCMtb
II RUTI administered twice 4 weeks apart to 4 volunteers, and placebo administered twice 4 weeks apart to other 2.	Biological: RUTI 25 micrograms of FCMtb
III RUTI administered twice 4 weeks apart to 4 volunteers, and placebo administered twice 4 weeks apart to other 2.	Biological: RUTI 100 micrograms of FCMtb
IV RUTI administered twice 4 weeks apart to 4 volunteers, and placebo administered twice 4 weeks apart to other 2.	Biological: RUTI 200 micrograms of FCMtb

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 >50g a day
Lost of more than 400mL of blood within 12 weeks, or more than 250mL 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 nonesteroid and corticosteroid drugs.
Acute disease with >37ºC temperature within 72 hours before the first vaccination.

Contacts and Locations

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

Locations

Spain, Barcelona
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

Experimental Tuberculosis Unit homepage This link exits the ClinicalTrials.gov site

Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol homepage This link exits the ClinicalTrials.gov site

Archivel Farma s.l. homepage This link exits the ClinicalTrials.gov site

Responsible Party:	Fundacio Institut Germans Trias i Pujol ( Pere-Joan Cardona )
Study ID Numbers:	FA/MI/01, EudraCT Number: 2006-000690-29
Study First Received:	October 16, 2007
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00546273
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Germans Trias i Pujol Hospital:

LTBI (Latent tuberculosis infection)
TB(Tuberculosis)
Vaccine

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis
Healthy

Additional relevant MeSH terms:

Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009