A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) (THYB-03)
Primary Purpose
Tuberculosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Antigen (Ag85B-ESAT-6)
Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Sponsored by

About this trial
This is an interventional prevention trial for Tuberculosis focused on measuring safety, immunogenicity, adjuvanted TB subunit vaccine
Eligibility Criteria
Inclusion Criteria:
- Male between 18 and 40 years old
- 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:
- Confirmed active TB based on clinical evaluation(history, physical findings and investigations)
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
12 TST negative volunteers antigen only
12 TST negative volunteers
12 BCG vaccinated volunteers
12 with Latent TB infection >= 2 years ago
Arm Description
Outcomes
Primary Outcome Measures
Safety on Physical examination , and Laboratory safety tests of hematology clinical chemistry
Secondary Outcome Measures
Immunogenicity assessment by: A.Detection of IFN gama production after stimulation with Ag85B, ESAT-6 and H1. B.Detection of IgG antibodies to recombinant proteins Ag85B, ESAT-6 and H1 in serum/plasma.
Full Information
NCT ID
NCT01049282
First Posted
January 13, 2010
Last Updated
April 16, 2015
Sponsor
Statens Serum Institut
1. Study Identification
Unique Protocol Identification Number
NCT01049282
Brief Title
A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)
Acronym
THYB-03
Official Title
A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered in Different Antigen/Adjuvant Formulations in TST Negative and TST Positive Volunteers at 0 and 2 Months
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Statens Serum Institut
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study has the following objectives:
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.
Detailed Description
Number of trial subjects=48 Investigational product=Ag85B - ESAT-6 + IC31 Dosage Group 1: TST negative, 50 µg antigen Group 2: TST negative, 50 µg antigen + fixed adjuvant Group 3: BCG vaccinated, 50 µg antigen + fixed adjuvant Group 4 : Latent TB, 50 µg antigen + fixed adjuvant Dosage volume 0.5 ml Administration Intramuscularly into deltoid muscle, alternate arms at day 0 (right) and day 56 (left).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
safety, immunogenicity, adjuvanted TB subunit vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
12 TST negative volunteers antigen only
Arm Type
Experimental
Arm Title
12 TST negative volunteers
Arm Type
Experimental
Arm Title
12 BCG vaccinated volunteers
Arm Type
Experimental
Arm Title
12 with Latent TB infection >= 2 years ago
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Antigen (Ag85B-ESAT-6)
Intervention Description
Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Intervention Type
Biological
Intervention Name(s)
Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Intervention Description
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Primary Outcome Measure Information:
Title
Safety on Physical examination , and Laboratory safety tests of hematology clinical chemistry
Time Frame
12 visits in a total of 224 days duratiion from the day of first vaccinantion
Secondary Outcome Measure Information:
Title
Immunogenicity assessment by: A.Detection of IFN gama production after stimulation with Ag85B, ESAT-6 and H1. B.Detection of IgG antibodies to recombinant proteins Ag85B, ESAT-6 and H1 in serum/plasma.
Time Frame
12 visits in a total of 224 days duratiion from the day of first vaccinantion
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male between 18 and 40 years old
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:
Confirmed active TB based on clinical evaluation(history, physical findings and investigations)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jemal Hussein, MD
Organizational Affiliation
Armauer Hansen Research Institue/AHRI/,Ethiopia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Bang, Msc
Organizational Affiliation
Statens serum Institute/SSI/,Denamrk
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
29321075
Citation
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.
Results Reference
derived
Learn more about this trial
A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)
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