NCT00546273

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Latent Tuberculosis Infection
• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	RUTI	dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
BIOLOGICAL	RUTI	dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
BIOLOGICAL	RUTI	dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
BIOLOGICAL	RUTI	dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
BIOLOGICAL	placebo of the vaccine RUTI	placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-10-18
• Last updated: 2009-05-27
• Results posted: 2009-03-25

Locations

3 sites across 1 country: Spain