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Tuberculosis clinical trials

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NCT ID: NCT02109874 Completed - Tuberculosis Clinical Trials

A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 (C-011-404)

C-011-404
Start date: December 2008
Phase: Phase 1
Study type: Interventional

This Phase I study will be conducted as a randomized, placebo-controlled, double-blind, dose-escalation study in four groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. The study will be conducted at one or two sites located in South Africa. The purpose is to evaluate the safety and immunogenicity of two injections of AERAS 404 prepared with four escalating amounts of antigen in healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection.

NCT ID: NCT02106039 Completed - Diabetes Mellitus Clinical Trials

Pulmonary Tuberculosis Patients With Diabetes Mellitus

TANDEM
Start date: April 28, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of enhanced glycemic monitoring of diabetes upon diabetes glycaemic control during tuberculosis treatment in tuberculosis- diabetes patients.

NCT ID: NCT02097095 Completed - Tuberculosis Clinical Trials

Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)

Start date: August 2014
Phase: N/A
Study type: Observational

This is an independent optional sub-study parallel to TB-018 (NCT01755598) in which biological samples will be collected for future investigations on biological correlates, markers or prognostic factors for TB disease. Subjects who consent to enroll in TB-018, "A phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate tuberculosis (TB) vaccine GSK 692342 (M72/AS01E) against TB disease, in healthy adults aged 18-50 years, living in a TB endemic region", (see NCT 01755598) will be asked to participate in this sub-study. Subjects enrolled in TB-018 who also consent to C-041-972 will be followed according to the TB-018 protocol but will have additional blood samples collected for the sub-study.

NCT ID: NCT02090374 Completed - Asthma Clinical Trials

Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen

Start date: March 2014
Phase: N/A
Study type: Interventional

The investigators propose the development of a range of nasal spray challenge models to study the way the nose can respond to different types of nasal challenge that elicit different forms of inflammation. The investigators will carry out nasal challenge with bacterial and viral components and allergens. In this way the nasal upper respiratory tract mucosa is challenged with stimuli of the immune system, causing various types of inflammation. Samples will be taken by blotting the nostril surface and by scraping off tiny surface samples. The nose will be sprayed with a substance that is a single part of a bacteria or virus, or with an allergen. The material delivered by nasal spray is of high purity and is sterile, containing no live bacteria or viruses. The nasal spray substance contains molecular patterns that are recognised as foreign by the immune system, and at the right dose should stimulate the immune system, causing mild nasal inflammation. The study employs noninvasive methods of sampling using absorptive strips. These strips look and feel like tissue paper, and are applied to each nostril for a period of 1 min. A few pinhead-sized tissue samples are taken from inside the nose, using a small disposable sterile plastic probe that has a tiny scoop on its end. In the nasal lining fluid and tissue samples, measurement will taken of a range of molecules and cells that protect against infections and help the immune response. By spraying the nose with a challenge agent in this manner, the nasal immune response can be assessed, which can help us better understand how the human immune system cells and molecules respond to bacteria and viruses. In the future, this may allow the testing of new drugs and vaccines, by seeing if they decrease or stop the inflammation after the nasal challenge.

NCT ID: NCT02088892 Completed - Tuberculosis Clinical Trials

A Clinical Challenge Study of BCG in Healthy Volunteers

Start date: March 2014
Phase: N/A
Study type: Interventional

TB031 is a challenge study comparing two different strains of the Bacille Calmette-Guérin (BCG) vaccine at standard and high dose.

NCT ID: NCT02082340 Completed - Tuberculosis Clinical Trials

Innovative Approach in Tuberculosis Care in Armenia

Start date: March 2014
Phase: N/A
Study type: Interventional

Randomized trial tests effectiveness of self-administered drug intake by empowered TB patients - supervised by a trained family member and supported by medical counseling and reminders - to improve treatment adherence and treatment success rates, and thereby forestall TB and MDR-TB epidemics.

NCT ID: NCT02076139 Completed - Tuberculosis Clinical Trials

Safety and Immunogenicity of Nyaditum Resae® Probiotic to Protect From Tuberculosis

Start date: March 2014
Phase: N/A
Study type: Interventional

This is a double-blind, masked, compared with placebo clinical trial in healthy volunteers with or without tuberculosis infection. This trial aims to study the effect of the probiotic Nyaditum resae® at the level of specific Regulatory T cells (Treg) memory cells one week after the first administration and the global tolerability of the treatment. Nyaditum resae® is a preparation in the form of drinkable vials containing heat-killed environmental mycobacteria. The overall objective of the study is the effect of Nyaditum resae® on immunity, which could reduce the risk of developing active tuberculosis.

NCT ID: NCT02075203 Completed - Tuberculosis Clinical Trials

Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents

Start date: February 2014
Phase: Phase 2
Study type: Interventional

Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents

NCT ID: NCT02074956 Completed - Tuberculosis Clinical Trials

A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 Administered in Adults

Start date: May 2008
Phase: Phase 1
Study type: Interventional

This Phase I study will be conducted as a randomized, double-blind, dose-escalation study in five groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. Since BCG-vaccinated individuals are the target population for which AERAS 404 might be indicated, AERAS 404 will be administered to individuals already vaccinated with BCG

NCT ID: NCT02073669 Completed - Latent Tuberculosis Clinical Trials

Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults

Start date: March 2014
Phase: N/A
Study type: Interventional

The aim of study is to evaluate the prevalence of latent TB in second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the control native Israelis without a family member who was born in a country with high incidence of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators expect that the second generation immigrants group will have more positive IGRA test than the control native group.