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

Condition(s) targeted: Tuberculosis

Intervention: C-Tb (Biological); Tuberculin PPD RT 23 SSI (Biological); C-Tb / Tuberculin PPD RT 23 SSI (Biological)

Phase: Phase 2/Phase 3

Status: Not yet recruiting

Sponsored by: Statens Serum Institut

Official(s) and/or principal investigator(s):
Pernille N Tingskov, BN, RN, Study Director, Affiliation: Statens Serum Institut
Keertan Dheda, MD, Prof, Principal Investigator, Affiliation: UCT Lung Institute, University of Cape Town

Overall contact:
Keertan Dheda, MD, Prof, Phone: + 27 (0) 21 404 7650, Email: keertan.dheda@uct.ac.za

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome:

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:

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

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Keertan Dheda, MD, Prof, Phone: + 27 (0) 21 404 7650, Email: keertan.dheda@uct.ac.za

Worthwhile Clinical Trials, Benoni 1501, South Africa; Not yet recruiting
I Mitha, MD, Phone: + 27 (0) 11 422 1928, Email: drmitha@iafrica.com
I Mitha, MD, Principal Investigator

TASK, M2, Karl Bremer Hospital,, Cape Town 7530, South Africa; Not yet recruiting
Zoja Novelijc, MD, Phone: + 27 (0) 21 949 7751, Email: dr.zoja@task.org.za
Zoja Novelijc, MD, Principal Investigator

Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town 7530, South Africa; Not yet recruiting
M Siebert, MD, Phone: + 27 (0) 21 957 9400, Email: msiebert@ttctrials.co.za
M Siebert, MD, Principal Investigator

UCT Lung Institute, Cape Town 7925, South Africa; Not yet recruiting
Keertan Dheda, MD, Prof, Phone: + 27 (0) 21 404 7650, Email: keertan.dheda@uct.ac.za
Keertan Dheda, MD, Prof, Principal Investigator

Primecure Medicentre, Port Elizabeth 6014, South Africa

Setshaba Research Centre, Pretoria 0152, South Africa; Not yet recruiting
M Malahleha, MD, Phone: + 27 (0) 12 799 2422, Email: mookho@setshaba.org.za
M Malahleha, MD, Principal Investigator

Synexus Stanza Bopape Clinic, Pretoria 0122, South Africa; Not yet recruiting
Boitumelo Sebopa, MD, Phone: + 27 (0) 12 812 0469, Email: SBCRInv1@synexus-sa.co.za
Boitumelo Sebopa, MD, Principal Investigator

Be Part Yoluntu Centre, Paarl, Western Cape 7626, South Africa; Not yet recruiting
Elizabeth Hellstrom, Phone: + 27 (0) 21 868 3990, Email: boylouw@mweb.co.za
Elizabet Hellstrom, MD, Principal Investigator

Starting date: February 2013
Last updated: January 29, 2013