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

Statens Serum Institut1 site in 1 country20 target enrollmentSeptember 2007

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Tuberculosis
Sponsor: Statens Serum Institut
Enrollment: 20
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

The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

June 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Male and female between 18 and 55 years old
•BCG group: Known to be BCG-vaccinated over 2 years before, PPD positive (range 6-15 mm or any documented value between 6-15 mm on medical file in the past), with no active, chronic or past TB disease as confirmed by chest X ray, negative QuantiFERON-TB Gold In Tube test and negative 6-day lymphocyte tests.
•Infection group: Known to be treated for latent TB, PPDpositive (equal or over 10 mm or documented equal or over 10 mm positive on medical file in the past), previously TB infected but with no active disease confirmed by chest X ray, may have received chemoprophylaxis but with no TB treatment/chemoprophylaxis within the preceding 2 years, positive QuantiFERON-TB Gold In Tube test and/or positive 6-day lymphocyte test.
•Healthy based on medical examination/history at the inclusion
•Signed informed consent
•Prepared to grant authorized persons access to the medical records
•The volunteer is likely to comply with instructions

•Granulomatous disease (by chest X-ray)
•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
•Participation in other clinical trials
•Known hypersensitivity to any of the vaccine components
•Laboratory parameters outside of normal range judged by PI to be clinically relevant
•Pregnant women/planned pregnancy and/or breastfeeding within the trial period

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

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

Detection by ELISPOT of IFNgamma spot-forming cells in PBMCs. Detection by ELISA of IFNgamma production in supernatants of PBMC. Detection by ELISA of IgG antibodies in serum/plasma. Detection by Elisa of TNFalfa and IFNgamma in serum(From first vaccination until 8 months after first vaccination)