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

NCT01779102 | Completed Phase 2 DMC

• 1 other identifier: TESEC-07
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  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

  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

  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

  Onset from the injection(s) to 28 days after the injections

Study Arms (3)

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

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

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

Biological: C-Tb / Tuberculin PPD RT 23 SSI

Interventions

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

0.1 µg C-Tb

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

2 T.U Tuberculin PPD RT 23 SSI

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

0.1 µg C-Tb / 2 T.U Tuberculin PPD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• positive rapid tests or

You may not qualify if:

• Has been in treatment for TB for more than 2 weeks
• Has a known MDR/XDR-TB
• 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

Sponsors & Collaborators

• Statens Serum Institut: lead

Study Sites (7)

TASK, M2, Karl Bremer Hospital,

Cape Town, Cape Town, 7530, South Africa

Location

Tiervlei Trial Centre, Karl Bremer Hospital

Cape Town, Cape Town, 7530, South Africa

Location

UCT Lung Institute

Cape Town, Cape Town, 7925, South Africa

Location

Primecure Medicentre

Port Elizabeth, Port Elizabeth, 6014, South Africa

Location

Synexus Stanza Bopape Clinic

Pretoria, Pretoria, 0122, South Africa

Location

Setshaba Research Centre

Pretoria, Pretoria, 0152, South Africa

Location

Be Part Yoluntu Centre

Paarl, Western Cape, 7626, South Africa

Location

Related Publications (1)

• 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.

  PMID: 30572979 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Pernille N Tingskov, BN, RN

  Statens Serum Institut

  STUDY DIRECTOR

• Keertan Dheda, MD, Prof

  UCT Lung Institute, University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 30, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

ZA (7)