TuberculosisPhase 1THYB-03NCT01049282
A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)
A Phase 1 study testing Antigen (Ag85B-ESAT-6) and Antigen (Ag85B-ESAT-6) with adjuvant (IC31) in people with Tuberculosis, run by Statens Serum Institut.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Antigen (Ag85B-ESAT-6) and Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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).
- Conditions
- Tuberculosis
- Being tested
- Antigen (Ag85B-ESAT-6), Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
- Keywords
- safety, immunogenicity, adjuvanted TB subunit vaccine
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antigen (Ag85B-ESAT-6)Biological
Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Antigen (Ag85B-ESAT-6) with adjuvant (IC31)Biological
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
| Study group | Role | What they receive |
|---|---|---|
| 12 TST negative volunteers antigen only | Experimental | Not described Receives: Biological: Antigen (Ag85B-ESAT-6) |
| 12 TST negative volunteers | Experimental | Not described Receives: Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31) |
| 12 BCG vaccinated volunteers | Experimental | Not described Receives: Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31) |
| 12 with Latent TB infection >= 2 years ago | Experimental | Not described Receives: Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety on Physical examination , and Laboratory safety tests of hematology clinical chemistry
Measured: 12 visits in a total of 224 days duratiion from the day of first vaccinantion
Secondary outcomes (1)
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.
Measured: 12 visits in a total of 224 days duratiion from the day of first vaccinantion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startDec 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jemal Hussein, MD, Principal investigator, Armauer Hansen Research Institue/AHRI/,EthiopiaPeter Bang, Msc, Study director, Statens serum Institute/SSI/,Denamrk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049282
- Sponsor's protocol ID
- THYB-03
- Acronym
- THYB-03
- Status last verified
- Apr 2015
- First submitted
- 13 Jan 2010
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29321075
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01049282
- Acronym / sponsor ID
- THYB-03 / THYB-03
- Conditions
- Tuberculosis
- Keywords
- safety, immunogenicity, adjuvanted TB subunit vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 12 TST negative volunteers antigen only | Experimental | Biological: Antigen (Ag85B-ESAT-6) |
| 12 TST negative volunteers | Experimental | Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31) |
| 12 BCG vaccinated volunteers | Experimental | Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31) |
| 12 with Latent TB infection >= 2 years ago | Experimental | Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antigen (Ag85B-ESAT-6)Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval | Biological | 12 TST negative volunteers antigen only |
| Antigen (Ag85B-ESAT-6) with adjuvant (IC31)Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval | Biological | 12 BCG vaccinated volunteers, 12 TST negative volunteers, 12 with Latent TB infection >= 2 years ago |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
- Derived from this study: PubMed 29321075Hussein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jemal Hussein, MD principal investigator
Armauer Hansen Research Institue/AHRI/,Ethiopia
Peter Bang, Msc study director
Statens serum Institute/SSI/,Denamrk
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Antigen (Ag85B-ESAT-6) and Antigen (Ag85B-ESAT-6) with adjuvant (IC31) in people with Tuberculosis, run by Statens Serum Institut.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01049282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.