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

NCT00546273 | Completed Phase 1 Results DMC

• 2 other identifiers: FA/MI/01EudraCT Number: 2006-000690-29
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Latent Tuberculosis Infection; Tuberculosis

Keywords

LTBI (Latent tuberculosis infection); TB(Tuberculosis); Vaccine

Outcome Measures

Primary Outcomes (3)

• VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point

  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

  during the whole study

• Number of Clinically Relevant Abnormalities in the Laboratory Tests According to the Doctors' Impression

  haematological and biochemical laboratory tests

  at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156

Secondary Outcomes (1)

• Evaluation of the Immunogenicity of the Different Doses of the Vaccine Tested

  at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156

Study Arms (5)

RUTI 5 micrograms of FCMtb

EXPERIMENTAL

RUTI dose: 5 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)

Biological: RUTI

RUTI 25 micrograms of FCMtb

EXPERIMENTAL

RUTI dose: 25 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)

Biological: RUTI

RUTI 100 micrograms of FCMtb

EXPERIMENTAL

RUTI dose: 100 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)

Biological: RUTI

RUTI 200 micrograms of FCMtb

EXPERIMENTAL

RUTI 200 micrograms of FCMtb (for fragmented cells of M. tuberculosis) (n=4)

Biological: RUTI

placebo

PLACEBO COMPARATOR

placebo of the vaccine RUTI (total n=8, n=2 for each period)

Biological: placebo of the vaccine RUTI

Interventions

RUTI BIOLOGICAL

dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28

Also known as: FCMtb is the active compound of the vaccine RUTI

RUTI 5 micrograms of FCMtb

placebo of the vaccine RUTI BIOLOGICAL

placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28

Also known as: placebo

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent
• Male Caucasian subjects, aged between 18 and 40 years
• Willing and likely to be able to comply with the trial procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Archivel Farma S.L.: collaborator

Study Sites (3)

Experimental Tuberculosis Unit. Fundació Institut per la Investigació Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Pharmacology Department. Hospital Universitari Germans Trias i Pujol.

Badalona, Barcelona, 08916, Spain

Location

Related Publications (6)

• Cardona PJ, Amat I, Gordillo S, Arcos V, Guirado E, Diaz J, Vilaplana C, Tapia G, Ausina V. Immunotherapy with fragmented Mycobacterium tuberculosis cells increases the effectiveness of chemotherapy against a chronical infection in a murine model of tuberculosis. Vaccine. 2005 Feb 3;23(11):1393-8. doi: 10.1016/j.vaccine.2004.09.008.

  PMID: 15661388 BACKGROUND

• Cardona PJ, Amat I. [Origin and development of RUTI, a new therapeutic vaccine against Mycobacterium tuberculosis infection]. Arch Bronconeumol. 2006 Jan;42(1):25-32. doi: 10.1016/s1579-2129(06)60110-9. Spanish.

  PMID: 16426520 BACKGROUND

• Cardona PJ. RUTI: a new chance to shorten the treatment of latent tuberculosis infection. Tuberculosis (Edinb). 2006 May-Jul;86(3-4):273-89. doi: 10.1016/j.tube.2006.01.024. Epub 2006 Mar 20.

  PMID: 16545981 BACKGROUND

• Vilaplana C, Ruiz-Manzano J, Gil O, Cuchillo F, Montane E, Singh M, Spallek R, Ausina V, Cardona PJ. The tuberculin skin test increases the responses measured by T cell interferon-gamma release assays. Scand J Immunol. 2008 Jun;67(6):610-7. doi: 10.1111/j.1365-3083.2008.02103.x. Epub 2008 Apr 4.

  PMID: 18397200 BACKGROUND

• Guirado E, Gil O, Caceres N, Singh M, Vilaplana C, Cardona PJ. Induction of a specific strong polyantigenic cellular immune response after short-term chemotherapy controls bacillary reactivation in murine and guinea pig experimental models of tuberculosis. Clin Vaccine Immunol. 2008 Aug;15(8):1229-37. doi: 10.1128/CVI.00094-08. Epub 2008 Jun 4.

  PMID: 18524883 BACKGROUND

• Gil O, Vilaplana C, Guirado E, Diaz J, Caceres N, Singh M, Cardona PJ. Enhanced gamma interferon responses of mouse spleen cells following immunotherapy for tuberculosis relapse. Clin Vaccine Immunol. 2008 Nov;15(11):1742-4. doi: 10.1128/CVI.00255-08. Epub 2008 Sep 30.

  PMID: 18827194 BACKGROUND

Related Links

• Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol homepage

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Results Point of Contact

• Title: Cristina Vilaplana, MD
• Organization: UTE. Fund. Inst. Germans Trias i Pujol

cvilaplana@gmail.com

+34 93 497 86 81

Study Officials

• 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"

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 18, 2007
• Study Start: April 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 27, 2009
• Results First Posted: March 25, 2009

Record last verified: 2009-05

Locations

ES (3)