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

NCT ID: NCT01779102

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-09-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

0.1 µg C-Tb

The C-Tb agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme

Group Type: EXPERIMENTAL

C-Tb

Intervention Type: 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

2 T.U Tuberculin PPD RT 23 SSI

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

Group Type: ACTIVE_COMPARATOR

Tuberculin PPD RT 23 SSI

Intervention Type: 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

0.1 µg C-Tb / 2 T.U Tuberculin PPD

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

Group Type: EXPERIMENTAL

C-Tb / Tuberculin PPD RT 23 SSI

Intervention Type: 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

Interventions

C-Tb

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

Intervention Type: BIOLOGICAL

Tuberculin PPD RT 23 SSI

Tuberculin is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme

Intervention Type: BIOLOGICAL

C-Tb / Tuberculin PPD RT 23 SSI

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Has signed an informed consent
• Aged 18 to 65 years
• Has been diagnosed with active pulmonary TB:

1. has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or

2. 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:

1. has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or

2. 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:

1. 2 positive rapid tests or

2. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Statens Serum Institut

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pernille N Tingskov, BN, RN

Role: STUDY_DIRECTOR

Statens Serum Institut

Keertan Dheda, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

UCT Lung Institute, University of Cape Town

Locations

TASK, M2, Karl Bremer Hospital,

Cape Town, Cape Town, South Africa

Tiervlei Trial Centre, Karl Bremer Hospital

Cape Town, Cape Town, South Africa

UCT Lung Institute

Cape Town, Cape Town, South Africa

Primecure Medicentre

Port Elizabeth, Port Elizabeth, South Africa

Synexus Stanza Bopape Clinic

Pretoria, Pretoria, South Africa

Setshaba Research Centre

Pretoria, Pretoria, South Africa

Be Part Yoluntu Centre

Paarl, Western Cape, South Africa

Countries

South Africa

References

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.

Reference Type: DERIVED

PMID: 30572979 (View on PubMed)

Other Identifiers

TESEC-07

Identifier Type: -

Identifier Source: org_study_id