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

Tuberculosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779102
• Other study ID #: TESEC-07
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 18, 2013
• Last updated: April 16, 2015
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Statens Serum Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• 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
• 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
• 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

Locations

Country	Name	City	State
South Africa	TASK, M2, Karl Bremer Hospital,	Cape Town
South Africa	Tiervlei Trial Centre, Karl Bremer Hospital	Cape Town
South Africa	UCT Lung Institute	Cape Town
South Africa	Be Part Yoluntu Centre	Paarl	Western Cape
South Africa	Primecure Medicentre	Port Elizabeth
South Africa	Setshaba Research Centre	Pretoria
South Africa	Synexus Stanza Bopape Clinic	Pretoria

Sponsors (1)

Lead Sponsor	Collaborator
Statens Serum Institut

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes