TuberculosisPhase 1NCT00793702
Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration
A Phase 1 study testing rdESAT-6 + rCFP-10 in people with Tuberculosis, run by Statens Serum Institut at 1 site in Denmark.
Trial summary
The primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when injected twice with time intervals of 6 or… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- rdESAT-6 + rCFP-10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2008to Jul 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has signed an informed consent
- Is willing and likely to be able to comply with the trial procedures
- Is female/male non-black adult ≥ 18 years and ≤ 55 years of age
- Is healthy according to a medical examination, medical history and laboratory investigations at inclusion
- Is prepared to grant authorized persons access to their medical records
Who cannot join
- Has a history of tuberculosis or has had a known contact to a person with active tuberculosis
- Has a positive QuantiFERON-TB Gold In Tube test result at inclusion
- Laboratory parameters outside of normal range judged by principal investigator to be clinically significant and/or abnormal glucose or protein levels in a urine sample at inclusion
- Has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine, infliximab or blood products)
- Has been vaccinated with a live vaccine within 6 months prior to the day of inclusion (e.g., MMR, yellow fever, or oral typhoid vaccines)
- Has a known congenital or acquired immune deficiency
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- Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukemia, sarcoidosis)
- Is known to be infected with HIV, HBV or HCV
- Has a severe ongoing viral or bacterial infection that might affect the cell mediated immune response at inclusion
- Has a C-reactive protein (CRP) level > 50 mg/L
- Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection site(s)
- Has a condition in which repeated blood drawings pose more than minimal risk for the volunteer, such as haemophilia, other coagulation disorders, or significantly impaired venous access
- Is actively participating in another clinical trial or has participated in previous clinical trials investigating the rdESAT-6 skin test reagent
- Is pregnant according to urine pregnancy test at inclusion
- Is a female not willing to use contraceptives or is breastfeeding
- Has a condition which in the opinion of the investigator is not suitable for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Phase I Clinical Trial on the Safety and Risk of Sensitisation by Escalating Doses and Repeated Injections of the rdESAT-6 + rCFP-10 Skin Test Reagent Following Intradermal Administration to Healthy Adults
The primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when injected twice with time intervals of 6 or 12 weeks to healthy adults.
- Conditions
- Tuberculosis
- Being tested
- rdESAT-6 + rCFP-10
- Keywords
- tuberculosis, diagnosis, ESAT-6, CFP-10, skin test, Skin test for the diagnosis of tuberculosis infection
- Medical subject headings
- Tuberculosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rdESAT-6 + rCFP-10Biological
rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | two injections 0.01 µg rdESAT-6 + rCFP-10 (6 weeks interval) Receives: Biological: rdESAT-6 + rCFP-10 |
| B | Experimental | two injections 0.01 µg rdESAT-6 + rCFP-10 (12 weeks interval) Receives: Biological: rdESAT-6 + rCFP-10 |
| C | Experimental | two injections 0.1 µg rdESAT-6 + rCFP-10 (6 weeks interval) Receives: Biological: rdESAT-6 + rCFP-10 |
| D | Experimental | two injections 0.1 µg rdESAT-6 + rCFP-10 (12 weeks interval) Receives: Biological: rdESAT-6 + rCFP-10 |
| E | Experimental | one injection 1.0 µg rdESAT-6 + rCFP-10 Receives: Biological: rdESAT-6 + rCFP-10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic adverse events with onset after the FIRST (0.01, 0.1 and 1.0 µg) or SECOND (0.01 and 0.1 µg) injection
Measured: onset between the first injection and 28 days after the second injection
Secondary outcomes (1)
The diameter of induration at the second injection site measured transversely to the long axis of the forearm
Measured: 72 hours after the second injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2009
- Study completionJul 2009
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pernille Nyholm Tingskov, Study director, Statens Serum Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793702
- Sponsor's protocol ID
- TESEC-01
- Other IDs
- EUDRACT No.: 2008-001489-96
- Status last verified
- Jan 2013
- First submitted
- 17 Nov 2008
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bergstedt W, Tingskov PN, Thierry-Carstensen B, Hoff ST, Aggerbeck H, Thomsen VO, Andersen P, Andersen AB. First-in-man open clinical trial of a combined rdESAT-6 and rCFP-10 tuberculosis specific skin test reagent. PLoS One. 2010 Jun 25;5(6):e11277. doi: 10.1371/journal.pone.0011277.
PubMed 20593018
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Phase I Clinical Trial on the Safety and Risk of Sensitisation by Escalating Doses and Repeated Injections of the rdESAT-6 + rCFP-10 Skin Test Reagent Following Intradermal Administration to Healthy Adults
- ClinicalTrials.gov ID
- NCT00793702
- Acronym / sponsor ID
- TESEC-01
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, diagnosis, ESAT-6, CFP-10, skin test, Skin test for the diagnosis of tuberculosis infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Nov 2008 (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 primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when injected twice with time intervals of 6 or 12 weeks to healthy adults.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: rdESAT-6 + rCFP-10two injections 0.01 µg rdESAT-6 + rCFP-10 (6 weeks interval) |
| B | Experimental | Biological: rdESAT-6 + rCFP-10two injections 0.01 µg rdESAT-6 + rCFP-10 (12 weeks interval) |
| C | Experimental | Biological: rdESAT-6 + rCFP-10two injections 0.1 µg rdESAT-6 + rCFP-10 (6 weeks interval) |
| D | Experimental | Biological: rdESAT-6 + rCFP-10two injections 0.1 µg rdESAT-6 + rCFP-10 (12 weeks interval) |
| E | Experimental | Biological: rdESAT-6 + rCFP-10one injection 1.0 µg rdESAT-6 + rCFP-10 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Has signed an informed consent
- Is willing and likely to be able to comply with the trial procedures
- Is female/male non-black adult ≥ 18 years and ≤ 55 years of age
- Is healthy according to a medical examination, medical history and laboratory investigations at inclusion
- Is prepared to grant authorized persons access to their medical records
Key exclusion criteria (16 listed)
- Has a history of tuberculosis or has had a known contact to a person with active tuberculosis
- Has a positive QuantiFERON-TB Gold In Tube test result at inclusion
- Laboratory parameters outside of normal range judged by principal investigator to be clinically significant and/or abnormal glucose or protein levels in a urine sample at inclusion
- Has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine, infliximab or blood products)
- Has been vaccinated with a live vaccine within 6 months prior to the day of inclusion (e.g., MMR, yellow fever, or oral typhoid vaccines)
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 |
|---|---|---|
| rdESAT-6 + rCFP-10rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique | Biological | A, B, C, D, E |
Primary outcome
Local and systemic adverse events with onset after the FIRST (0.01, 0.1 and 1.0 µg) or SECOND (0.01 and 0.1 µg) injection
Time frame: onset between the first injection and 28 days after the second injection
1 secondary outcome
The diameter of induration at the second injection site measured transversely to the long axis of the forearm
Time frame: 72 hours after the second injection
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 21 Jan 2013.
- Derived from this study: PubMed 20593018Bergstedt W, Tingskov PN, Thierry-Carstensen B, Hoff ST, Aggerbeck H, Thomsen VO, Andersen P, Andersen AB. First-in-man open clinical trial of a combined rdESAT-6 and rCFP-10 tuberculosis specific skin test reagent. PLoS One. 2010 Jun 25;5(6):e11277. doi: 10.1371/journal.pone.0011277.
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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.
Pernille Nyholm Tingskov study director
Statens Serum Institut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rdESAT-6 + rCFP-10 in people with Tuberculosis, run by Statens Serum Institut at 1 site in Denmark.
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 5 inclusion and 16 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 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Local and systemic adverse events with onset after the FIRST (0.01, 0.1 and 1.0 µg) or SECOND (0.01 and 0.1 µg) injection (time frame: onset between the first injection and 28 days after the second injection). 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 NCT00793702, 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 21 Jan 2013.