NCT00929396CompletedPhase 1
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 enrollmentStarted: September 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- 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.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Latent TB infection group
Experimental
The latent TB group will receive two injections of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart.
Intervention: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a) (Biological)
BCG vaccinated group
Experimental
The BCG vaccinated group will receive two vaccinations of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart
Intervention: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a) (Biological)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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