A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine
NCT ID: NCT01003093
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
36 participants
INTERVENTIONAL
2005-11-30
2008-06-30
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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Antigen group + high adjuvans
The antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart.
50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a
0.5 mL suspension for injection x 2 with 2 months interval
Antigen group
The antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart.
50 microgram antigen (Ag85B + ESAT-6)
0.5 mL suspension for injection x 2 with 2 months interval
Antigen + low adjuvans group
The antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 nmol ODN1a) two months apart.
50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a
0.5 mL suspension for injection x 2 with 2 months interval
Interventions
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50 microgram antigen (Ag85B + ESAT-6)
0.5 mL suspension for injection x 2 with 2 months interval
50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a
0.5 mL suspension for injection x 2 with 2 months interval
50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a
0.5 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
* 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
* 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
18 Years
55 Years
MALE
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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Ottenhoff TH, Doherty TM, van Dissel JT, Bang P, Lingnau K, Kromann I, Andersen P. First in humans: a new molecularly defined vaccine shows excellent safety and strong induction of long-lived Mycobacterium tuberculosis-specific Th1-cell like responses. Hum Vaccin. 2010 Dec;6(12):1007-15. doi: 10.4161/hv.6.12.13143. Epub 2010 Dec 1.
van Dissel JT, Arend SM, Prins C, Bang P, Tingskov PN, Lingnau K, Nouta J, Klein MR, Rosenkrands I, Ottenhoff TH, Kromann I, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31 promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in naive human volunteers. Vaccine. 2010 Apr 30;28(20):3571-81. doi: 10.1016/j.vaccine.2010.02.094. Epub 2010 Mar 11.
Other Identifiers
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Eudract number: TEST-001599-14
Identifier Type: -
Identifier Source: secondary_id
THYB-01
Identifier Type: -
Identifier Source: org_study_id
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