A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered at 0 and 2 Months

Statens Serum Institut1 site in 1 country36 target enrollmentNovember 2005

ConditionsTuberculosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Tuberculosis
Sponsor: Statens Serum Institut
Enrollment: 36
Locations: 1
Primary Endpoint: Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

June 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Statens Serum Institut

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy based on medical examination/history at the inclusion
•Age between 18 and 55 years
•Signed informed consent
•Prepared to grant authorized persons access to the medical records
•The volunteer is likely to comply with instructions

Exclusion Criteria

•Known exposure to TB before (or expected during) the trial
•Prior BCG vaccination
•Granulomatous disease (by chest X-ray, autoimmune screen)
•Vaccinated with live vaccine 3 months before first vaccination
•Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination
•HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab)
•Participation in other clinical trials
•Positive Mantoux or QuantiFERON-TB Gold
•Known hypersensitivity to any of the vaccine components
•Laboratory parameters outside of normal ranges considered clinically relevant

Outcomes

Primary Outcomes

Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests.

Time Frame: From the first vaccination until 8 months after the first vaccination

Secondary Outcomes

Detection by ELISPOT of IFN gamma spot-forming cells in PBMC. Detection by ELISA of IFN gamma production in supernatants of PBMC. Detection of humoral response (IgG) by ELISA.(From first vaccination until 36 months after first vaccination)