Overview

This trial is active, not recruiting.

Conditions tuberculosis, healthy
Treatment biological mtbvac and biological bcg (commercial)
Sponsor Biofabri, S.L
Collaborator University of Zaragoza
Start date January 2013
End date June 2014
Trial size 36 participants
Trial identifier NCT02013245, MTBVAC-01

Summary

The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential substitute for BCG vaccination.BCG vaccination has indeed demonstrated its major limitation in inducing protection against tuberculosis (TB). Novel vaccines are essential to fight against the current world epidemics in tuberculosis and resistance to anti-TB drugs.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Biological: MTBVAC Biological: BCG (BCG Dose: 5 x 10e5 cfu/0.1ml)
biological mtbvac and biological bcg (commercial)
Biological: MTBVAC Biological: BCG (BCG Dose: 5 x 10e5 cfu/0.1ml)
biological mtbvac and biological bcg (commercial)
Biological: MTBVAC Biological: BCG (BCG Dose: 5 x 10e5 cfu/0.1ml)
biological mtbvac and biological bcg (commercial)

Primary Outcomes

Measure
Safety and reactogenicity for all subjects.
time frame: 7 months follow up

Secondary Outcomes

Measure
Cell mediated immune response assessment
time frame: 7 months follow up

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

Inclusion Criteria: - Subjects who the Investigator believes that they can and will comply with the requirements of the protocol - Subjects who have no evidence of exposition to BCG as demonstrated by a ELISPOT PPD assay along with no history of BCG vaccination and no BCG scar - A male or female between, and including, 18 and 45 years of age at the time of the vaccination. - Written informed consent obtained from the subject prior to any study procedure. - If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception - Clinically acceptable laboratory values for blood tests. - Seronegative for human immunodeficiency virus 1 and -2 (HIV-1/2) antibodies, p24 antigen, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies. - No evidence of pulmonary pathology as confirmed by chest X-ray. - No history of extrapulmonary TB. - No history of previous contact with M. tuberculosis (latent tuberculosis) as demonstrated by a negative ELISPOT Tb (ESAT-6, CFP10) assay. Exclusion Criteria: - History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunisations (any vaccine). - History of allergic disease or reactions - History of previous administration of experimental Mycobacterium tuberculosis vaccines. - Use of any investigational or non-registered product (drug or vaccine) in another experimental protocol other than the study vaccines within 30 days preceding the vaccination, or planned use during the study period. - Any chronic drug therapy to be continued during the study period. - Chronic administration of immunosuppressors or other immune-modifying drugs. - Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the vaccination, or planned administrations during the study period. - Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV) based on medical history and physical examination. - Any condition or history of any acute or chronic illness or medication which, in the opinion of the Investigator, may interfere with the evaluation of the study objectives. - A family history of congenital or hereditary immunodeficiency. - A stay of more than 2 months in a highly endemic area (e.g. Eastern Europe (Romania, Bulgaria) and low-income countries) within 6 months prior to the screening visit or travel of more than 2 months foreseen in an area of high endemicity after the enrolment into the study. - History of any neurologic disorders or seizures. - History of chronic alcohol consumption and/or drug abuse. - Major congenital defects. - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions.

Additional Information

Official title Phase I Double Blind, Randomized, Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC in Comparison With BCG in Elispot TB(ESAT-6, CFP10, PPD)- and HIV- Negative Volunteers
Principal investigator François Spertini, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Biofabri, S.L.