A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)
NCT ID: NCT01049282
Last Updated: 2015-04-17
Study Results
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Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2008-12-31
2010-04-30
Brief Summary
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Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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12 TST negative volunteers antigen only
Antigen (Ag85B-ESAT-6)
Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
12 TST negative volunteers
Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
12 BCG vaccinated volunteers
Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
12 with Latent TB infection >= 2 years ago
Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Interventions
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Antigen (Ag85B-ESAT-6)
Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Eligibility Criteria
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Inclusion Criteria
* TST negative groups: TST- and negative QuantiFERON-TB Gold In tube test
* BCG group: known to be BCG-vaccinated \> 2 years before(scar, vaccination card), TST+ (\> 6 or any documented value \> 6 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: latent TB, TST+ ( = or \> 10 mm or documented = or \> 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 any vaccine 3 months before first vaccination
* Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins)
* 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 considered clinically relevant
18 Years
40 Years
MALE
Yes
Sponsors
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Statens Serum Institut
OTHER
Responsible Party
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Principal Investigators
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Jemal Hussein, MD
Role: PRINCIPAL_INVESTIGATOR
Armauer Hansen Research Institue/AHRI/,Ethiopia
Peter Bang, Msc
Role: STUDY_DIRECTOR
Statens serum Institute/SSI/,Denamrk
References
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Hussein J, Zewdie M, Yamuah L, Bedru A, Abebe M, Dagnew AF, Chanyalew M, Yohannes AG, Ahmed J, Engers H, Doherty TM, Bang P, Kromann I, Hoff ST, Aseffa A. A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31(R) in people living in a TB-endemic area. Trials. 2018 Jan 10;19(1):24. doi: 10.1186/s13063-017-2354-0.
Other Identifiers
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THYB-03
Identifier Type: -
Identifier Source: org_study_id
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