TuberculosisPhase 2/3TESEC-07NCT01779102
Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses
A Phase 2/3 study testing C-Tb, Tuberculin PPD RT 23 SSI and C-Tb / Tuberculin PPD RT 23 SSI in people with Tuberculosis, run by Statens Serum Institut at 7 sites in South Africa.
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 induration 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 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- C-Tb, Tuberculin PPD RT 23 SSI and C-Tb / 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
- 456 participants
- Where
- 7 sitesSouth Africa
- Study dates
- Oct 2013to Sep 2014
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signed an informed consent
- Aged 18 to 65 years
- Has been diagnosed with active pulmonary TB:
- has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or
- has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis
- Is HIV negative confirmed by 2 two rapid tests
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- Is willing and likely to comply with the trial procedures
- Is prepared to grant authorized persons access to their medical record
- Has signed an informed consent
- Aged 18-65 years
- Has been diagnosed with active pulmonary TB:
- has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or
- has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis
- Is HIV positive confirmed by:
- 2 positive rapid tests or
- 1 positive rapid tests and an additional confirmatory ELISA
- A CD4 count has been performed
- 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 been in treatment for TB for more than 2 weeks
- Has a known MDR/XDR-TB
- Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines) except BCG vaccine
- Has been tuberculin (TST) tested < 12 months prior to the day of inclusion
- Is pregnant, breastfeeding or intending to get pregnant
- Is a female of child bearing potential not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures during the trial period
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- Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
- 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 patient, 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 CFP-10 antigens
- Has a condition which in the opinion of the investigator is not suitable for participation in the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Africa7 sites
TASK, M2, Karl Bremer Hospital,
Cape Town, Cape Town, 7530
Tiervlei Trial Centre, Karl Bremer Hospital
Cape Town, Cape Town, 7530
UCT Lung Institute
Cape Town, Cape Town, 7925
Be Part Yoluntu Centre
Paarl, Western Cape, 7626
Primecure Medicentre
Port Elizabeth, Port Elizabeth, 6014
Synexus Stanza Bopape Clinic
Pretoria, Pretoria, 0122
Setshaba Research Centre
Pretoria, Pretoria, 0152
About this study
Official title: A Phase II/III Trial Investigating if Concomitant Injections of the Diagnostic Agents C-Tb and 2 T.U Tuberculin PPD RT 23 SSI Affect the Induration Responses in Combination With a Safety Assessment of C-Tb
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 induration at the injection site, while a negative test will leave no reactions.
The aim of this study is to address if the size of induration and the sensitivity of C-Tb is influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is to evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.
Read the detailed description
The TESEC-07 trial is a GCP double blind randomised controlled phase II/III trial investigating if concomitant injections of the diagnostic agents C-Tb and 2 T.U Tuberculin PPD RT 23 SSI affect the induration responses in combination with a safety assessment of C-Tb. TESEC-07 is a multi-centre trial and will be conducted in South Africa in patients recently diagnosed with TB comprising 360 HIV negative and 90 HIV positive adults allocated to 3 trial groups.
- A within group paired comparison of 0.1 μg/0.1 mL C-Tb and PPD RT 23 in 150 TB patients. The C-Tb and PPD RT 23 agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a randomisation scheme.
- A group of 150 TB patients will only receive the C-Tb agent randomised to either RIGHT or LEFT forearm.
- A group of 150 TB patients will only receive the reference agent PPD RT 23 randomised to either RIGHT or LEFT forearm.
- Conditions
- Tuberculosis
- Being tested
- C-Tb, Tuberculin PPD RT 23 SSI, C-Tb / Tuberculin PPD RT 23 SSI
- 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
C-Tb is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
Tuberculin PPD RT 23 SSIBiological
Tuberculin is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
C-Tb / Tuberculin PPD RT 23 SSIBiological
The C-Tb and Tuberculin agents are administered by the Mantoux injection technique to each volunteer in the RIGHT and LEFT forearm according to a double blind randomisation scheme
| Study group | Role | What they receive |
|---|---|---|
| 0.1 µg C-Tb | Experimental | The C-Tb agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme Receives: Biological: C-Tb |
| 2 T.U Tuberculin PPD RT 23 SSI | Active comparator | The 2 T.U Tuberculin PPD RT 23 SSI agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme Receives: Biological: Tuberculin PPD RT 23 SSI |
| 0.1 µg C-Tb / 2 T.U Tuberculin PPD | Experimental | The C-Tb and 2 T.U Tuberculin PPD RT 23 SSI agents are given concomitantly to volunteers in the RIGHT and LEFT forearms according to a double blind randomisation scheme Receives: Biological: C-Tb / Tuberculin PPD RT 23 SSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives)
Measured: Onset from the injection(s) to 28 days after the injections
To assess if concomitant injections of C-Tb and PPD RT 23 influence the tests abilities to identify positive results of Tuberculosis in Tuberculosis infected patients
Measured: Onset from the injection(s) to 28 days after the injections
Secondary outcomes (3)
To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the in vitro QuantiFERON®TB Gold In Tube assay in blood collected immediately before application of the C-Tb skin test
Measured: Onset from the injection(s) to 28 days after the injections
To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the PPD RT 23 test
Measured: Onset from the injection(s) to 28 days after the injections
To assess the safety of C-Tb skin test by investigating laboratory safety parameters and assessing all adverse events (local and systemic) occurring within 28 days after administration of the C-Tb and/or PPD RT 23 tests
Measured: Onset from the injection(s) to 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 posted30 Jan 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pernille N Tingskov, BN, RN, Study director, Statens Serum InstitutKeertan Dheda, MD, Prof, Principal investigator, UCT Lung Institute, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779102
- Sponsor's protocol ID
- TESEC-07
- Acronym
- TESEC-07
- Status last verified
- Apr 2015
- First submitted
- 18 Jan 2013
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aggerbeck H, Ruhwald M, Hoff ST, Tingskov PN, Hellstrom E, Malahleha M, Siebert M, Gani M, Diacon A, Novelijc Z, Andersen P, Dheda K. Interaction between C-Tb and PPD given concomitantly in a split-body randomised controlled trial. Int J Tuberc Lung Dis. 2019 Jan 1;23(1):38-44. doi: 10.5588/ijtld.18.0137. Epub 2018 Dec 20.
PubMed 30572979
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 Phase II/III Trial Investigating if Concomitant Injections of the Diagnostic Agents C-Tb and 2 T.U Tuberculin PPD RT 23 SSI Affect the Induration Responses in Combination With a Safety Assessment of C-Tb
- ClinicalTrials.gov ID
- NCT01779102
- Acronym / sponsor ID
- TESEC-07 / TESEC-07
- Conditions
- Tuberculosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Jan 2013 (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 induration at the injection site, while a negative test will leave no reactions.
The aim of this study is to address if the size of induration and the sensitivity of C-Tb is influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is to evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.
Detailed description
The TESEC-07 trial is a GCP double blind randomised controlled phase II/III trial investigating if concomitant injections of the diagnostic agents C-Tb and 2 T.U Tuberculin PPD RT 23 SSI affect the induration responses in combination with a safety assessment of C-Tb. TESEC-07 is a multi-centre trial and will be conducted in South Africa in patients recently diagnosed with TB comprising 360 HIV negative and 90 HIV positive adults allocated to 3 trial groups.
- A within group paired comparison of 0.1 μg/0.1 mL C-Tb and PPD RT 23 in 150 TB patients. The C-Tb and PPD RT 23 agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a randomisation scheme.
- A group of 150 TB patients will only receive the C-Tb agent randomised to either RIGHT or LEFT forearm.
- A group of 150 TB patients will only receive the reference agent PPD RT 23 randomised to either RIGHT or LEFT forearm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.1 µg C-Tb | Experimental | Biological: C-TbThe C-Tb agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme |
| 2 T.U Tuberculin PPD RT 23 SSI | Active comparator | Biological: Tuberculin PPD RT 23 SSIThe 2 T.U Tuberculin PPD RT 23 SSI agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme |
| 0.1 µg C-Tb / 2 T.U Tuberculin PPD | Experimental | Biological: C-Tb / Tuberculin PPD RT 23 SSIThe C-Tb and 2 T.U Tuberculin PPD RT 23 SSI agents are given concomitantly to volunteers 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Has signed an informed consent
- Aged 18 to 65 years
- Has been diagnosed with active pulmonary TB:
- Is HIV negative confirmed by 2 two rapid tests
- Is willing and likely to comply with the trial procedures
Key exclusion criteria (12 listed)
- Has been in treatment for TB for more than 2 weeks
- Has a known MDR/XDR-TB
- Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines) except BCG vaccine
- Has been tuberculin (TST) tested < 12 months prior to the day of inclusion
- Is pregnant, breastfeeding or intending to get pregnant
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-TbC-Tb is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme | Biological | 0.1 µg C-Tb |
| Tuberculin PPD RT 23 SSITuberculin is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme | Biological | 2 T.U Tuberculin PPD RT 23 SSI |
| C-Tb / Tuberculin PPD RT 23 SSIThe C-Tb and Tuberculin agents are administered by the Mantoux injection technique to each volunteer in the RIGHT and LEFT forearm according to a double blind randomisation scheme | Biological | 0.1 µg C-Tb / 2 T.U Tuberculin PPD |
Primary outcome
To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives)
Time frame: Onset from the injection(s) to 28 days after the injections
To assess if concomitant injections of C-Tb and PPD RT 23 influence the tests abilities to identify positive results of Tuberculosis in Tuberculosis infected patients
Time frame: Onset from the injection(s) to 28 days after the injections
3 secondary outcomes
To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the in vitro QuantiFERON®TB Gold In Tube assay in blood collected immediately before application of the C-Tb skin test
Time frame: Onset from the injection(s) to 28 days after the injections
To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the PPD RT 23 test
Time frame: Onset from the injection(s) to 28 days after the injections
To assess the safety of C-Tb skin test by investigating laboratory safety parameters and assessing all adverse events (local and systemic) occurring within 28 days after administration of the C-Tb and/or PPD RT 23 tests
Time frame: Onset from the injection(s) to 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 17 Apr 2015.
- Derived from this study: PubMed 30572979Aggerbeck H, Ruhwald M, Hoff ST, Tingskov PN, Hellstrom E, Malahleha M, Siebert M, Gani M, Diacon A, Novelijc Z, Andersen P, Dheda K. Interaction between C-Tb and PPD given concomitantly in a split-body randomised controlled trial. Int J Tuberc Lung Dis. 2019 Jan 1;23(1):38-44. doi: 10.5588/ijtld.18.0137. Epub 2018 Dec 20.
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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 N Tingskov, BN, RN study director
Statens Serum Institut
Keertan Dheda, MD, Prof principal investigator
UCT Lung Institute, University of Cape Town
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing C-Tb, Tuberculin PPD RT 23 SSI and C-Tb / Tuberculin PPD RT 23 SSI in people with Tuberculosis, run by Statens Serum Institut at 7 sites in South Africa.
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 19 inclusion and 12 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.
Where is the study taking place?
The record lists 7 sites in South Africa. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives) (time frame: Onset from the injection(s) to 28 days after the injections). The study lists 2 primary outcomes in all. 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 NCT01779102, 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.