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Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses (TESEC-07)

Primary Purpose

Tuberculosis

Status

Completed

Phase

Phase 2

Locations

South Africa

Study Type

Interventional

Intervention

C-Tb

Tuberculin PPD RT 23 SSI

C-Tb / Tuberculin PPD RT 23 SSI

About this trial

This is an interventional diagnostic trial for Tuberculosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (HIV Negative patients):

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

Inclusion Criteria (HIV Positive patients):

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

Sites / Locations

Be Part Yoluntu Centre
TASK, M2, Karl Bremer Hospital,
Tiervlei Trial Centre, Karl Bremer Hospital
UCT Lung Institute
Primecure Medicentre
Synexus Stanza Bopape Clinic
Setshaba Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

0.1 µg C-Tb

2 T.U Tuberculin PPD RT 23 SSI

0.1 µg C-Tb / 2 T.U Tuberculin PPD

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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)

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

Secondary Outcome Measures

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

To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the PPD RT 23 test

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

Full Information

NCT ID

NCT01779102

First Posted

January 18, 2013

Last Updated

April 16, 2015

Sponsor

Statens Serum Institut

1. Study Identification

Unique Protocol Identification Number

NCT01779102

Brief Title

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

Acronym

TESEC-07

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Statens Serum Institut

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

456 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.1 µg C-Tb

Arm Type

Experimental

Arm Description

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

Arm Title

2 T.U Tuberculin PPD RT 23 SSI

Arm Type

Active Comparator

Arm Description

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

Arm Title

0.1 µg C-Tb / 2 T.U Tuberculin PPD

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

C-Tb

Intervention Description

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

Intervention Name(s)

Tuberculin PPD RT 23 SSI

Intervention Description

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

Intervention Name(s)

C-Tb / Tuberculin PPD RT 23 SSI

Intervention Description

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 Outcome Measure Information:

Title

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