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CompletedNCT01642888Updated Apr 14, 2016

A Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®, in Combination With a Safety Assessment of C-Tb Versus Tuberculin PPD RT23 SSI

A Phase 3 interventional study of C-Tb and 2 T.U. Tuberculin PPD RT 23 SSI in Tuberculosis, sponsored by Statens Serum Institut. Completed at 9 sites in South Africa. Open to participants aged 28 Days to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-14.

Sponsored by Statens Serum Institut · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
1,190
Allocation
Randomized
Ages
28 Days to 65 Years
Sex
All
01

Study summary

Tuberculosis (TB) continues to be one of the most serious bacterial infections worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.

The new skin test is named C-Tb. Like the current tuberculin skin test, PPD, the C-Tb test is injected just under the skin and will, when positive, show redness and/or swelling at the injection site while a negative test will leave no reactions. The investigators hope that this new C-Tb skin test will be more precise (specific) than the PPD test, as the PPD test e.g. may show a reaction if the person tested is BCG vaccinated.

The aim of this trial is to test the C-Tb skin test in volunteers suspected of having TB disease.

With focus on age, HIV status and CD4 count the following analyses are done (in an overall perspective):

  • To compare the C-Tb test to a blood test, the QuantiFERON test.
  • To compare the C-Tb test to the PPD test that is currently being used.
  • To assess the safety of the C-Tb test.
Read the detailed description

The TESEC-05 trial is an open comparison of the diagnostics performance of C-Tb compared to the QuantiFERON®-TB Gold In-Tube, in combination with a double-blind randomized split-body safety assessment of C-Tb versus to 2 T.U. Tuberculin PPD RT23 SSI.

The trial is a multi-centre Phase III clinical trial designed specifically to address C-Tb in relation to the paediatric population and to HIV infection. The intention is to evaluate how the C-Tb test performs in the paediatric population with respect to safety, and to ensure that SSI will be able to extrapolate data obtained in an adult population to the paediatric population.

Furthermore, the intention is both to evaluate the diagnostic performance and safety of C-Tb in HIV infected individuals and to evaluate whether SSI will be able to extrapolate data obtained in a non-HIV population to a HIV population.

The trial population will consist of paediatric participants with suspected TB infection and adult participants suspected to have TB disease. Furthermore a control group of 100 children between 5 - 11 years of age with no symptoms or known exposure will be recruited from an area with a "low" prevalence of TB (an area with an incidence rate \< 299/100,000 per year, the average rate of TB in South Africa in 2005 was 645/100,000 per year.

The trial will be conducted in South Africa where the prevalence of HIV infection is high and MTb infections are endemic.

BCG vaccination at birth has been common practice since 1961 in South Africa. Thus most of the participants are presumed BCG vaccinated.

02

Conditions studied

  • Tuberculosis

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03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 1,190 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Statens Serum Institut is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Days to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

HIV NEGATIVE PARTICIPANTS:

  1. Participants between 5 and 65 years attending the TB clinic due to suspicion of TB disease
  2. Infants, toddlers and children between 28 days and 4 years must either have symptoms or signs of TB or be in close contact to a smear positive pulmonary TB case (more than 6 hours/day for at least five days)
  3. Is between 28 days and 65 years of age
  4. Participant, parent or legal guardian has signed the informed consent
  5. Is HIV negative confirmed by two rapid tests. However, children between 28 days and 4 years may have an unknown HIV status and may receive antiretroviral therapy (ART) or have breastfeeding mothers on ART
  6. Is willing and likely to comply with the trial procedures
  7. Is prepared to grant authorized persons access to their medical record

HIV POSITIVE PARTICIPANTS:

  1. Participants between 5 and 65 years attending the TB clinic due to suspicion of TB disease
  2. Infants, toddlers and children between 28 days and 4 years must either have symptoms* or signs** of TB or be in close contact to a smear positive pulmonary TB case (more than 6 hours/day for at least five days)
  3. Is between 28 days and 65 years of age
  4. Participant, parent or legal guardian has signed the informed consent

  5. Is HIV positive confirmed by:

    1. two positive rapid tests or
    2. 1 positive rapid test and an additional confirmatory ELISA test
  6. A CD4 count has been done
  7. Is willing and likely to comply with the trial procedures
  8. Is prepared to grant authorized persons access to their medical record

HIV NEGATIVE CONTROL GROUP:

  1. Participant with no known contact to people infected with MTb and no signs or symptoms of TB.
  2. Is between 5 and 11 years of age
  3. Participant, parent or legal guardian has signed the informed consent
  4. Is HIV negative confirmed by two rapid tests
  5. Is willing and likely to comply with the trial procedures
  6. Is prepared to grant authorized persons access to their medical record

Exclusion criteria

Exclusion Criteria:

HIV NEGATIVE PARTICIPANTS:

  1. Has a confirmed diagnosis of tuberculosis at Screening Visit
  2. 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
  3. Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion
  4. Is pregnant, breastfeeding or intending to get pregnant during the trial period
  5. Is a female of child bearing potential (12 years of age or older) not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures during the trial period
  6. Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
  7. Has a current skin condition which interferes with the reading of the C-Tb and PPD e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites
  8. Has a condition where blood drawings pose more than minimal risk for the participant, such as haemophilia, other coagulation disorders or significantly impaired venous access
  9. 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
  10. Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens
  11. Has a condition which in the opinion of the investigator is not suitable for participation in the trial

HIV POSITIVE PARTICIPANTS:

  1. Has a confirmed diagnosis of tuberculosis at Screening Visit
  2. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines)
  3. Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion
  4. Is pregnant, breastfeeding or intending to get pregnant during the trial period
  5. Is a female of child bearing potential (12 years of age or older) not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures during the trial period
  6. Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
  7. Has a known diagnosis of AIDS or is receiving antiviral therapy at the time of Screening Visit
  8. Has a current skin condition which interferes with the reading of the C-Tb and PPD e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites
  9. Has a condition where blood drawings pose more than minimal risk for the participant, such as haemophilia, other coagulation disorders or significantly impaired venous access
  10. 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
  11. Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens
  12. Has a condition which in the opinion of the investigator is not suitable for participation in the trial

HIV NEGATIVE CONTROL GROUP:

  1. 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
  2. Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion
  3. Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
  4. Has a current skin condition which interferes with the reading of the C-Tb and PPD e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites
  5. Has a condition where blood drawings pose more than minimal risk for the participant, such as haemophilia, other coagulation disorders, or significantly impaired venous access
  6. 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
  7. Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens
  8. Has a condition which in the opinion of the investigator is not suitable for participation in the trial
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,190 participants (actual)

Study arms

  • Experimental
    0.1 µg/0.1 mL C-Tb

    The C-Tb and 2 T.U. 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

    Biological: C-Tb

  • Active comparator
    2 T.U. Tuberculin PPD RT 23 SSI

    The C-Tb and 2 T.U. 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

    Biological: 2 T.U. Tuberculin PPD RT 23 SSI

Interventions

  • BiologicalC-Tb

    The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme

  • Biological2 T.U. Tuberculin PPD RT 23 SSI

    The 2 T.U. Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme

06

What researchers measure

Primary outcomes

  1. To evaluate the diagnostic performance of C-Tb in relation to age, HIV and CD4 counts

    Time frame: Onset between the injections and 28 days after the injections

  2. To evaluate the clinical safety of C-Tb, with emphasis on children and HIV positive participants

    Time frame: Onset between the injections and 28 days after the injections

Secondary outcomes

  1. To evaluate the difference in sensitivity between C-Tb and QuantiFERON®-TB Gold in-Tube in trial participants with confirmed TB diagnosis, overall, and according to age and HIV status.

    Time frame: From injections to 2-3 days after the injections

  2. To evaluate the difference in sensitivity between C-Tb and Tuberculin PPD RT23 SSI in trial participants with confirmed TB diagnosis overall, and according to age and HIV status.

    Time frame: Onset between the injections and 28 days after the injections

  3. To evaluate the difference in specificity between C-Tb and QuantiFERON®-TB Gold in-Tube in the control group of 100 children aged 5 - 11 years with no TB symptoms and no known exposure to MTb overall, and according to age.

    Time frame: From injections to 2-3 days after the injections

  4. To evaluate the difference in specificity between C-Tb and Tuberculin PPD RT23 SSI in the control group of 100 children aged 5 - 11 years with no TB symptoms and no known exposure to MTb overall, and according to age.

    Time frame: Onset between the injections and 28 days after the injections

  5. To compare the diagnostic outcome of C-Tb to that of QuantiFERON®-TB Gold in-Tube using a latent class approach

    Time frame: From injections to 2-3 days after the injections

  6. To compare the diagnostic outcome of C-Tb to that of Tuberculin PPD RT23 SSI using a latent class approach

    Time frame: Onset between the injections and 28 days after the injections

  7. To evaluate the diagnostic performance of Tuberculin PPD RT23 SSI in relation to age, HIV status and CD4 counts

    Time frame: Onset between the injections and 28 days after the injections

  8. To evaluate the clinical safety of Tuberculin PPD RT23 SSI

    Time frame: Onset between the injections and 28 days after the injections

  9. To evaluate the diagnostic performance of QuantiFERON®-TB Gold in-Tube in relation to age, HIV status and CD4 counts

    Time frame: On the day of the injections

07

Study locations

9 sites
  • Primecure Medicentre, Mercantile Hospital
    Port Elizabeth, Eastern Cape 6014, South Africa
  • Worthwhile Clinical Trials, Lakeview Hospital
    Benoni 1501, Gauteng 1501, South Africa
  • Synnyside Medi-Clinic
    Pretoria, Gauteng 0002, South Africa
  • Synexus Stanza Bopape Clinic
    Pretoria, Gauteng 0122, South Africa
  • Setshaba Research Centre
    Pretoria, Gauteng 0152, South Africa
  • M2 Karl Bremer Hospital
    Bellville, Cape Town, Western Cape 7530, South Africa
  • Tiervlei Trial Centre, Karl Bremer Hospital
    Bellville, Cape Town, Western Cape 7530, South Africa
  • UCT Lung Institute, Groote Schuur Hospital
    Cape Town, Western Cape 7925, South Africa
  • Be Part Yoluntu Centre
    Paarl, Western Cape 7626, South Africa
08

References and documents

Publications

  • Aggerbeck H, Ruhwald M, Hoff ST, Borregaard B, Hellstrom E, Malahleha M, Siebert M, Gani M, Seopela V, Diacon A, Lourens M, Andersen P, Dheda K. C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial. PLoS One. 2018 Sep 24;13(9):e0204554. doi: 10.1371/journal.pone.0204554. eCollection 2018. PubMed 30248152 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01642888
Lead sponsor
Statens Serum Institut
Responsible party
Sponsor
First posted
Jul 17, 2012
Start date
Sep 2012
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Apr 14, 2016

Study contacts

Andreas Diacon, MD
principal investigator · M2 Karl Bremer Hospital
Henrik Aggerbeck, M.Sc.
study chair · Statens Serum Institut

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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