A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers
NCT ID: NCT00929396
Last Updated: 2013-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2007-09-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
o,5 mL suspension for injection x 2 with 2 months interval
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
50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
o,5 mL suspension for injection x 2 with 2 months interval
Interventions
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50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
o,5 mL suspension for injection x 2 with 2 months interval
50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
o,5 mL suspension for injection x 2 with 2 months interval
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Statens Serum Institut
OTHER
Responsible Party
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Principal Investigators
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Jaap van Dissel, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Centre
Locations
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Leiden University Medical Centre
Leiden, RC Leiden, Netherlands
Countries
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References
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van Dissel JT, Soonawala D, Joosten SA, Prins C, Arend SM, Bang P, Tingskov PN, Lingnau K, Nouta J, Hoff ST, Rosenkrands I, Kromann I, Ottenhoff TH, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31(R) promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in volunteers with previous BCG vaccination or tuberculosis infection. Vaccine. 2011 Mar 3;29(11):2100-9. doi: 10.1016/j.vaccine.2010.12.135. Epub 2011 Jan 20.
Other Identifiers
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THYB-02
Identifier Type: -
Identifier Source: org_study_id
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