- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00929396
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers (THYB-02)
January 18, 2013 updated by: Statens Serum Institut
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
The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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RC Leiden
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Leiden, RC Leiden, Netherlands, 2300
- Leiden University Medical Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Latent TB infection group
The latent TB group will receive two injections of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart.
|
o,5 mL suspension for injection x 2 with 2 months interval
Other Names:
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Experimental: BCG vaccinated group
The BCG vaccinated group will receive two vaccinations of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart
|
o,5 mL suspension for injection x 2 with 2 months interval
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
From first vaccination until 8 months after the first vaccination
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: From first vaccination until 8 months after first vaccination
|
From first vaccination until 8 months after first vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jaap van Dissel, MD, Prof., Leiden University Medical Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
June 26, 2009
First Submitted That Met QC Criteria
June 26, 2009
First Posted (Estimate)
June 29, 2009
Study Record Updates
Last Update Posted (Estimate)
January 21, 2013
Last Update Submitted That Met QC Criteria
January 18, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- THYB-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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