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

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

Interventions

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

Sponsors & Collaborators

• Archivel Farma S.L.

  collaborator INDUSTRY

• Germans Trias i Pujol Hospital

  lead OTHER

Principal Investigators

• Pere-Joan Cardona, MD, PhD · Unitat de Tuberculosi Experimental. Fundació Institut per la Investigació en Ciències de la Salut Germans Trias i Pujol.

• Joan Costa, MD, PhD · Pharmacology Department. Hospital Universitari "Germans Trias i Pujol"

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2008-06-30

Completion

2008-06-30

Countries

• Spain

Study Locations