Clinical trials: tuberculosis
Tuberculosis
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine
The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to…
- Trial name
- THYB-01 (NCT01003093)
- Testing
- 50 microgram antigen (Ag85B + ESAT-6), 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a, 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Tuberculosis
Doxycycline in Human Pulmonary Tuberculosis
Pulmonary cavitation, a hallmark of tuberculosis (TB), is the site of high mycobacterial burden leading to disease transmission.
- Trial name
- Doxy-TB (NCT02774993)
- Testing
- Doxycycline
- Where
- Singapore
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National University Hospital, Singapore
Tuberculosis
A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin
The purpose of this study is to evaluate the safety, pharmacokinetics, and effects of imatinib on myelopoiesis in adults when given with and without isoniazid and rifabutin.
- Trial name
- IMPACT-TB (NCT03891901)
- Testing
- Imatinib, Isoniazid, Rifabutin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Innovation in Tuberculosis
Tuberculosis (TB) is one of the major infectious diseases worldwide, and the emergence and spread of drug resistant cases is a public health threat.
- Trial name
- INNOVA4TB (NCT04002869)
- Testing
- Immunologic, molecular, metabolomic and radiolologic diagnostic
- Where
- Spain
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Fundació Institut Germans Trias i Pujol
Tuberculosis
Comparison of Diagnostic Performance of C-Tb to QuantiFERON®-TB, in Combination With a Safety Assessment of C-Tb vs Tuberculin PPD RT23 SSI
Tuberculosis (TB) continues to be the most important bacterial infection worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB. We are investigating a new skin test named C-Tb.
- Trial name
- NCT01631266
- Testing
- C-Tb, 2 T.U. Tuberculin PPD RT 23 SSI
- Where
- 13 sites in Spain
- Volunteers
- 979 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers
This randomized, placebo-controlled, double-blind, safety and dose-finding Phase Ia trial will evaluate four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a…
- Trial name
- NCT05537038
- Testing
- BNT164a1, BNT164b1
- Where
- 3 sites in Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Tuberculosis
Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old.
This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety…
- Trial name
- NCT06305104
- Testing
- 2.5μg/ml EEC, 5μg/ml EEC, 5 unit（U） EC
- Where
- 6 sites in China
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- Chengdu CoenBiotech Co., Ltd
Tuberculosis
A Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®, in Combination With a Safety Assessment of C-Tb Versus Tuberculin PPD RT23 SSI
Tuberculosis (TB) continues to be one of the most serious bacterial infections worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB. The new skin test is named C-Tb.
- Trial name
- NCT01642888
- Testing
- C-Tb, 2 T.U. Tuberculin PPD RT 23 SSI
- Where
- 9 sites in South Africa
- Volunteers
- 1,190 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Tuberculosis Infection, Healthy Volunteer
Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women
This study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in…
- Conditions
- Tuberculosis Infection, Healthy Volunteer, Breastfeeding
- Trial name
- PRiMe (NCT07069582)
- Testing
- Standard dose rifampicin, High dose rifampicin, Standard dose isoniazid
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Tuberculosis
Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Rifampicin in Healthy Volunteers
The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of standard and high doses of rifampicin.
- Trial name
- NCT02387242
- Testing
- Rifampicin
- Where
- Singapore
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- National University Hospital, Singapore
Tuberculosis, HIV
Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus)
The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community…
- Trial name
- Triage (NCT02127983)
- Testing
- Early intervention, Delayed intervention
- Where
- Malawi
- Volunteers
- 200,000 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Healthy
First-in-Human Trial of the Novel Tuberculosis Vaccine Candidate, H107e/CAF®10b
Tuberculosis (TB) is an infection caused by bacteria passed from one person to another through the air when an infected person for instance coughs, speaks, or sneezes.
- Trial name
- nTB-01 (NCT06050356)
- Testing
- H107e, CAF®10b, H107e/CAF®10b - low adjuvant dose
- Where
- South Africa
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Latent Tuberculosis
Determining Risk in Latent Tuberculosis
Background: Tuberculosis (TB) is a leading cause of death worldwide. Those who are exposed to the TB bacteria but have not become sick are said to have latent TB.
- Trial name
- NCT01571739
- Where
- South Korea
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
A Knowledge Translation Intervention for TB/HIV Treatment Adherence, in Zomba District, Malawi
Despite increased emphasis on evidence based practice in recent years a gap remains between evidence and practice, particularly in resource poor countries.
- Trial name
- NCT01356095
- Testing
- Knowledge translation intervention, Palm-Plus
- Where
- Malawi
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Dignitas International
Tuberculosis
A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile females.
- Trial name
- NCT02066428
- Testing
- AERAS-404
- Where
- Sweden
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Aeras
HIV Infections, Tuberculosis
Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa
The purpose of this study is to estimate the amount of HIV and tuberculosis (TB) infection in individuals 15 years and older in the Masiphumelele township of Cape Town, South Africa.
- Trial name
- NCT00096681
- Volunteers
- 762 people, healthy volunteers welcome
- Sponsor
- CIPRA SA
Tuberculosis
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
This is a phase 1 study, in healthy volunteers who have previously been immunized with bacilli Calmette Guerin (BCG), to evaluate the safety and immune responses that develop in the blood and lungs following the administration by…
- Trial name
- NCT02337270
- Testing
- Ad5Ag85A
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- McMaster University
Tuberculosis, Pulmonary
Integrated Discovery and Development of Innovative TB Diagnostics
The long term goal of this project is to provide information critical to the development and use of a low-cost, point-of-care, rapid, simple, and highly accurate diagnostic tool that can help clinicians make a microbiological…
- Trial name
- (CETR) (NCT06624501)
- Testing
- Observational cohort study
- Volunteers
- 1,450 people, healthy volunteers welcome
- Sponsor
- Harvard University Faculty of Medicine
Tuberculosis
Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine
The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L tuberculosis vaccine versus matched placebo in…
- Trial name
- NCT02501421
- Testing
- tuberculosis vaccine
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Research Institute for Biological Safety Problems
Tuberculosis, Chronic Obstructive Pulmonary Disease
Biologic Basis Of Increased Susceptibility Of Smokers To Pulmonary Infection With Mycobacterium Tuberculosis
Identify a biologic (molecular) basis for the increased susceptibility of cigarette smokers to pulmonary TB (Mtb) by testing the hypothesis that smoking reprograms AM polarization towards a distinct phenotype associated with…
- Trial name
- NCT02021747
- Where
- Qatar
- Volunteers
- healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University