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NCT Number: NCT01779102

Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

TASK, M2, Karl Bremer Hospital,, Cape Town, South Africa

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(HIV Negative patients):

  • 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
  • Is willing and likely to comply with the trial procedures
  • Is prepared to grant authorized persons access to their medical record

Inclusion criteria

(HIV Positive patients):

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

C-Tb

Biological

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 SSI

Biological

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 SSI

Biological

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Statens Serum Institut

Other

Registry information

Official study 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

Acronym: TESEC-07

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2013
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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