TuberculosisPhase 2TESEC-03NCT01242475
A Trial of the C-Tb Skin Test, When Given Intradermally to Healthy Volunteers Previously Vaccinated With BCG
A Phase 2 study testing C-Tb and 2 TU Tuberculin PPD RT 23 SSI in people with Tuberculosis, run by Statens Serum Institut at 1 site in United Kingdom.
Trial summary
A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result will show as redness and/or swelling at the injection site, while a negative test will leave no reactions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- C-Tb and 2 TU Tuberculin PPD RT 23 SSI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Nov 2011
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has signed an informed consent
- Aged 18 to 65 years
- Is known to be BCG vaccinated (documented in medical files and/or by the presence of a BCG scar)
- Is healthy according to a medical examination and medical history at screening
- Is willing and likely to comply with the trial procedures
- Is prepared to grant authorized persons access to their medical records
Who cannot join
- Has a history of tuberculosis or has been in close contact to a person with active tuberculosis within 5 years from trial inclusion
- Has a positive QuantiFERON®-TB Gold In-Tube assay at inclusion
- Laboratory parameters outside of normal range judged by site investigator to be clinically significant
- Has within 3 months prior to the day of inclusion been in treatment with a product which is likely to modify the immune response (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine or blood products)
- Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines)
- Has been vaccinated with BCG < 6 months prior to the day of inclusion
Show all 20Show fewer
- Has been tuberculin (TST) tested < 6 months prior to the day of inclusion
- Has a known congenital or acquired immune deficiency
- Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
- Is infected with HIV
- Has a current skin condition which interferes with the reading of the skin tests e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites
- Has a condition where blood drawings pose more than minimal risk for the volunteer, such as haemophilia, other coagulation disorders, or significantly impaired venous access
- Currently participating in another clinical trial with an investigational or non investigational drug or device, or has participated in another clinical trial within the 3 months prior to dosing
- Has participated in previous clinical trials investigating the ESAT-6 and/or CPP-10 antigens
- Is pregnant, breast-feeding or intending to get pregnant
- Is a female not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures
- Has a history of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the 12 months preceding Visit 1
- Has a positive urine drug screen at Visit 1 and Visit 2 (i.e., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates)
- Has a positive alcohol breath test at Visit 1 and Visit 2. [NOTE: subjects must be told to avoid consumption of alcoholic beverages for at least 24 hours prior to attending the Centre]
- 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.
United Kingdom1 site
Surrey Clinical Research Centre, University of Surrey
Surrey, Guildford, Surrey, GU2 7XP
About this study
Official title: A Phase IIa Specificity Trial of the Diagnostic Agent C-Tb, When Given Intradermally by the Mantoux Technique to Healthy Volunteers Previously Vaccinated With BCG
A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result will show as redness and/or swelling at the injection site, while a negative test will leave no reactions.
The aim of this study is to test the C-Tb skin test in healthy adults previously BCG vaccinated to determine if healthy non tuberculosis infected individuals has a truly negative test result (this is called determining the specificity of the skin test). To be able to compare the new skin test with the current Tuberculin skin test volunteers will be injected with both the C-Tb and the TST skin test.
Read the detailed description
The trial is designed to investigate the specificity of C-Tb under various definitions of cut-off in a double blind randomised, split-body study comparing 0.1 µg/0.1 mL C-Tb with the reference agent 2 T.U. Tuberculin PPD RT23 SSI. (Each volunteer receives the C-Tb agent in one arm and the 2 T.U. Tuberculin PPD in the other arm).
The C-Tb and 2 T.U. Tuberculin PPD agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearm according to a double blind randomisation scheme.
The primary objective of the trial is to assess the specificity of the C-Tb test as a function of the cut-off value (i.e., the smallest size of induration measured in mm resulting in a negative outcome of the C-Tb test) when the test is administered intradermally by the Mantoux technique to healthy BCG vaccinated adults The specificity of the C-Tb test is defined as the relative frequency of subjects in a healthy population (i.e., no exposure to MTb) who have an induration response < cut-off after a C-Tb test.
Similarly the sensitivity is defined as the relative frequency of patients with an induration response ≥ cut-off in TB patients.
An optimal cut-off point of being infected will be determined by combing the results from the present specificity study with those from a parallel sensitivity study in patients recently diagnosed with TB.
The secondary objectives of the trial are to compare the induration response of C-Tb with the induration response of 2 T.U. Tuberculin PPD RT 23 SSI, to compare the induration response of C-Tb with the in-vitro IFN-γ response measured at screening and 28 days after the injections of the skin test agents using the QuantiFERON®-TB Gold In-Tube assay and finally to record all adverse events occurring within 28 days after application of the agents.
- Conditions
- Tuberculosis
- Being tested
- C-Tb, 2 TU Tuberculin PPD RT 23 SSI
- Keywords
- tuberculosis, rdESAT-6, CFP-10, skin test, diagnostic test
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-TbBiological
Also called rdESAT-6 + rCFP-10
The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme
2 TU Tuberculin PPD RT 23 SSIBiological
Also called PPD, Tuberculin
The 2TU Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme
| Study group | Role | What they receive |
|---|---|---|
| 0.1µg/0.1 mL C-Tb | Experimental | The C-Tb and 2 TU Tuberculin PPD RT 23 SSI agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a double blind randomisation scheme Receives: Biological: C-Tb |
| 2TU Tuberculin PPD RT 23 SSI | Active comparator | The C-Tb and 2 TU Tuberculin PPD RT 23 SSI agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a double blind randomisation scheme Receives: Biological: 2 TU Tuberculin PPD RT 23 SSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diameter of induration at the injection sites measured transversely to the long axis of the forearm 2-3 days after application of the agents
Measured: From injections to 2-3 days after application of the agents
Secondary outcomes (4)
Injection site adverse reactions within 28 days after application of the agents
Measured: Onset between the injections and 28 days after the injections
All adverse events occurring within 28 days after application of the agents
Measured: Onset between the injections and 28 days after the injections
Laboratory safety parameters of haematology and biochemistry
Measured: Onset between the injections and 28 days after the injections
In vitro IFN-γ response as measured by the QuantiFERON®-TB Gold In-Tube assay from blood samples taken at screening and 28 days after the injections of the skin test agents
Measured: Onset between the injections and 28 days after the injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startApr 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birgit Thierry-Carstensen, Study director, Statens Serum InstitutDavid JM Lewis, MD, Principal investigator, Surrey Clinical Research Centre, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242475
- Sponsor's protocol ID
- TESEC-03
- Other IDs
- 2009-017296-17, 2009
- Acronym
- TESEC-03
- Status last verified
- Jan 2013
- First submitted
- 16 Nov 2010
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
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
- A Phase IIa Specificity Trial of the Diagnostic Agent C-Tb, When Given Intradermally by the Mantoux Technique to Healthy Volunteers Previously Vaccinated With BCG
- ClinicalTrials.gov ID
- NCT01242475
- Acronym / sponsor ID
- TESEC-03 / TESEC-03
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, rdESAT-6, CFP-10, skin test, diagnostic test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Nov 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.
A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result will show as redness and/or swelling at the injection site, while a negative test will leave no reactions.
The aim of this study is to test the C-Tb skin test in healthy adults previously BCG vaccinated to determine if healthy non tuberculosis infected individuals has a truly negative test result (this is called determining the specificity of the skin test). To be able to compare the new skin test with the current Tuberculin skin test volunteers will be injected with both the C-Tb and the TST skin test.
Detailed description
The trial is designed to investigate the specificity of C-Tb under various definitions of cut-off in a double blind randomised, split-body study comparing 0.1 µg/0.1 mL C-Tb with the reference agent 2 T.U. Tuberculin PPD RT23 SSI. (Each volunteer receives the C-Tb agent in one arm and the 2 T.U. Tuberculin PPD in the other arm).
The C-Tb and 2 T.U. Tuberculin PPD agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearm according to a double blind randomisation scheme.
The primary objective of the trial is to assess the specificity of the C-Tb test as a function of the cut-off value (i.e., the smallest size of induration measured in mm resulting in a negative outcome of the C-Tb test) when the test is administered intradermally by the Mantoux technique to healthy BCG vaccinated adults The specificity of the C-Tb test is defined as the relative frequency of subjects in a healthy population (i.e., no exposure to MTb) who have an induration response < cut-off after a C-Tb test.
Similarly the sensitivity is defined as the relative frequency of patients with an induration response ≥ cut-off in TB patients.
An optimal cut-off point of being infected will be determined by combing the results from the present specificity study with those from a parallel sensitivity study in patients recently diagnosed with TB.
The secondary objectives of the trial are to compare the induration response of C-Tb with the induration response of 2 T.U. Tuberculin PPD RT 23 SSI, to compare the induration response of C-Tb with the in-vitro IFN-γ response measured at screening and 28 days after the injections of the skin test agents using the QuantiFERON®-TB Gold In-Tube assay and finally to record all adverse events occurring within 28 days after application of the agents.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.1µg/0.1 mL C-Tb | Experimental | Biological: C-TbThe C-Tb and 2 TU Tuberculin PPD RT 23 SSI agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a double blind randomisation scheme |
| 2TU Tuberculin PPD RT 23 SSI | Active comparator | Biological: 2 TU Tuberculin PPD RT 23 SSIThe C-Tb and 2 TU Tuberculin PPD RT 23 SSI agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a double blind randomisation scheme |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has signed an informed consent
- Aged 18 to 65 years
- Is known to be BCG vaccinated (documented in medical files and/or by the presence of a BCG scar)
- Is healthy according to a medical examination and medical history at screening
- Is willing and likely to comply with the trial procedures
Key exclusion criteria (20 listed)
- Has a history of tuberculosis or has been in close contact to a person with active tuberculosis within 5 years from trial inclusion
- Has a positive QuantiFERON®-TB Gold In-Tube assay at inclusion
- Laboratory parameters outside of normal range judged by site investigator to be clinically significant
- Has within 3 months prior to the day of inclusion been in treatment with a product which is likely to modify the immune response (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine or blood products)
- Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, 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 |
|---|---|---|
| C-TbAlso: rdESAT-6 + rCFP-10The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme | Biological | 0.1µg/0.1 mL C-Tb |
| 2 TU Tuberculin PPD RT 23 SSIAlso: PPD, TuberculinThe 2TU Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme | Biological | 2TU Tuberculin PPD RT 23 SSI |
Primary outcome
The diameter of induration at the injection sites measured transversely to the long axis of the forearm 2-3 days after application of the agents
Time frame: From injections to 2-3 days after application of the agents
4 secondary outcomes
Injection site adverse reactions within 28 days after application of the agents
Time frame: Onset between the injections and 28 days after the injections
All adverse events occurring within 28 days after application of the agents
Time frame: Onset between the injections and 28 days after the injections
Laboratory safety parameters of haematology and biochemistry
Time frame: Onset between the injections and 28 days after the injections
In vitro IFN-γ response as measured by the QuantiFERON®-TB Gold In-Tube assay from blood samples taken at screening and 28 days after the injections of the skin test agents
Time frame: Onset between the injections and 28 days after the injections
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.
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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.
Birgit Thierry-Carstensen study director
Statens Serum Institut
David JM Lewis, MD principal investigator
Surrey Clinical Research Centre, University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C-Tb and 2 TU Tuberculin PPD RT 23 SSI in people with Tuberculosis, run by Statens Serum Institut at 1 site in United Kingdom.
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 6 inclusion and 20 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The diameter of induration at the injection sites measured transversely to the long axis of the forearm 2-3 days after application of the agents (time frame: From injections to 2-3 days after application of the agents). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.