Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Zaragoza
Centre Hospitalier Universitaire Vaudois
Tuberculosis Vaccine Initiative (TBVI)
European Union
Information provided by (Responsible Party):
Biofabri, S.L
ClinicalTrials.gov Identifier:
NCT02013245
First received: December 3, 2013
Last updated: December 11, 2013
Last verified: December 2013

December 3, 2013
December 11, 2013
January 2013
June 2014   (final data collection date for primary outcome measure)
Safety and reactogenicity for all subjects. [ Time Frame: 7 months follow up ] [ Designated as safety issue: Yes ]

Safety and reactogenicity for all subjects as determined by:

  • Occurrence of solicited symptoms during the 7-day follow-up period following vaccination and occurrence of unsolicited symptoms during the 210-day follow-up period following vaccination.
  • Occurrence of grade 3 vaccine related local and general symptoms during the 210-day follow-up period following vaccination and occurrence of serious adverse events throughout the entire study period.
  • Haematological and biochemical safety test levels prior and after vaccination
Same as current
Complete list of historical versions of study NCT02013245 on ClinicalTrials.gov Archive Site
Cell mediated immune response assessment [ Time Frame: 7 months follow up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Adults aged 18 to 45 years, ELISPOT Tb and HIV negative

  • Tuberculosis
  • Healthy
Biological: Biological MTBVAC and biological BCG (commercial)
  • Cohort 1
    Biological: MTBVAC Biological: BCG (BCG Dose: 5 x 10e5 cfu/0.1ml)
    Intervention: Biological: Biological MTBVAC and biological BCG (commercial)
  • Cohort 2
    Biological: MTBVAC Biological: BCG (BCG Dose: 5 x 10e5 cfu/0.1ml)
    Intervention: Biological: Biological MTBVAC and biological BCG (commercial)
  • Cohort 3
    Biological: MTBVAC Biological: BCG (BCG Dose: 5 x 10e5 cfu/0.1ml)
    Intervention: Biological: Biological MTBVAC and biological BCG (commercial)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
Not Provided
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT02013245
MTBVAC-01
Yes
Biofabri, S.L
Biofabri, S.L
  • University of Zaragoza
  • Centre Hospitalier Universitaire Vaudois
  • Tuberculosis Vaccine Initiative (TBVI)
  • European Union
Principal Investigator: François Spertini, MD Centre Hospitalier Universitaire Vaudois
Biofabri, S.L
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP