Clinical trials: TB
Tuberculosis, Pulmonary
Epidemiologic Study to Assess the IGRA Positivity in Populations With a High TB Burden
The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a…
- Trial name
- NCT05190146
- Where
- 36 sites in Bangladesh, Brazil and 12 more
- Volunteers
- 7,203 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Mycobacterium Tuberculosis, Protection Against, Tuberculosis
ChAdOx1 85A Aerosol Versus Intramuscular Vaccination in Healthy Adults (TB039)
This is a dose escalating and a paired-placebo design study to describe the safety and immunogenicity profile of candidate TB vaccine ChAdOx1 85A given by aerosol inhaled vaccination versus intramuscular (IM) vaccination in adult…
- Trial name
- TB039 (NCT04121494)
- Testing
- ChadOx1 85A - aerosol, ChadOx1 85A - IM
- Where
- Switzerland
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- François Spertini
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
Prevention of TB Recurrence
Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence
This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo.
- Trial name
- NCT03152903
- Testing
- VPM1002 (Recombinant BCG Vaccine)
- Where
- 10 sites in Bangladesh, India
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Tuberculosis
Infant TB Infection Prevention Study
Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium tuberculosis infection in HIV-exposed uninfected (HEU) infants.
- Trial name
- iTIPS (NCT02613169)
- Testing
- Isoniazid
- Where
- Kenya
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Washington
Healthy Subjects
Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169
Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers
- Trial name
- NCT04150224
- Testing
- PBTZ169 640 mg OD, PBTZ169 640 mg BiD, PBTZ169 960 mg SD
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Tuberculosis
A Study for Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults
70 subjects received BCG intradermally at Study Day -42, then at Study Day 0 were randomized to receive AERAS-404 50 mcg H4/500 nmol IC31 intramuscularly as a 3-dose (N=30) or 2-dose (N=30) regimen, or placebo (N=10).
- Trial name
- C-013-404 (NCT02420444)
- Testing
- BCG SSI, AERAS-404
- Where
- Switzerland
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis
TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment
This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the pharmacokinetics of moxifloxacin among patients with…
- Trial name
- NCT00164463
- Testing
- Moxifloxacin, Isoniazid
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis (TB)
Phase I Trial Evaluating Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in BCG Vaccinated Adults
This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313 vaccination compared to MVA85A vaccination, in BCG vaccinated adults.
- Trial name
- NCT01879163
- Testing
- MVA85A-IMX313, MVA85A
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Oxford
TB
A Study of the Immunogenicity of BCG, Delivered Intradermally in Healthy Volunteers
To assess the immunogenicity of M. bovis BCG (SSI strain), given intrademally in the standard dose used in clinical practice and to measure the development of the immune response in the first six months after administration. M.
- Trial name
- NCT00480714
- Testing
- BCG (SSI Strain)
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
MVA85A Aerosol vs Intramuscular Vaccination in Adults With Latent Mycobacterium Tuberculosis (M. tb) Infection
TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route in healthy adult volunteers who are latently…
- Trial name
- NCT02532036
- Testing
- Aerosol inhaled MVA85A, Intramuscular MVA85A
- Where
- 5 sites in United Kingdom
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis (TB)
Tuberculosis (TB) Aftermath
TB Aftermath will compare effectiveness, cost-effectiveness and feasibility of two ACF strategies for detecting recurrent TB and provide evidence needed to implement and scale the preferred ACF strategy.
- Trial name
- NCT04333485
- Testing
- Home-based Active Case Finding (HACF), Telephonic Active Case Finding (TACF)
- Where
- India
- Volunteers
- 3,094 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Tuberculosis
Potential Role of Microbiome in Tuberculosis
Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), is a deadly infectious disease and major global public health problem.
- Trial name
- Micro-STOP (NCT04985994)
- Where
- 2 sites in Pakistan
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Khyber Medical University Peshawar
Tuberculosis
Prevalence of Latent Tuberculosis (TB) Infection Diagnosed by Interferon-gamma Release Assay and Tuberculin Skin Tests in Patients With Old Healed TB
We easily regard nodules and fibrosis in upper lobes of lung as TB sequelae. The aim of this study is to confirm the prevalence of latent TB infection diagnosed by interferon-gamma release assay and tuberculin skin tests in…
- Trial name
- NCT01099098
- Where
- South Korea
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Pulmonary Tuberculosis Suspected, Other Specified Chronic Obstructive Pulmonary Disease
ENOSE in Pulmonary Tuberculosis in Yogyakarta
Electronic noses detecting patterns of volatile molecules have recently been introduced for different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins et al (2013) in Bangladesh showed sensitivity…
- Conditions
- Pulmonary Tuberculosis Suspected, Other Specified Chronic Obstructive Pulmonary Disease, Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology
- Trial name
- YOGYATBNOSE (NCT02219945)
- Testing
- 5 min exhaled breath sampling with soft nose clamp
- Where
- Indonesia
- Volunteers
- 389 people, healthy volunteers welcome
- Sponsor
- Tjip van der Werf
HIV/AIDS, Tuberculosis
Targeted Universal TB Testing With Simultaneous TPT Prescribing Among People Living With HIV in South Africa
Background: In 2023, the South African Department of Health introduced targeted universal TB testing (TUTT) at antiretroviral therapy (ART) initiation (irrespective of the presence of TB symptoms).
- Trial name
- TUTT-PT (NCT06739915)
- Testing
- TUTT-PT Intervention
- Where
- South Africa
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Tuberculosis, Pulmonary
Digital Health Intervention to Improve TPT Uptake
Despite the evidence of the prevention and control measures of tuberculosis (TB), it still has an impact on the health, social, and economic aspects of the population.
- Trial name
- DHiTPT (NCT07313995)
- Testing
- Digital health intervention
- Where
- 14 sites in Ethiopia
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Arba Minch University
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents
This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.
- Trial name
- NCT00950612
- Testing
- GSK's investigational vaccine 692342
- Where
- South Africa
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
A Multiple Ascending Dose Study With a Dose Formulation Comparison Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects
The objective of the study is to evaluate the safety and tolerability of multiple doses of TBA-354 in healthy subjects.
- Trial name
- NCT02606214
- Testing
- TBA-354
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
HIV
Male Engagement in PMTCT Services
The study employs a quasi-experimental design in 8 public health centers in southwest Uganda offering care and treatment (C\&T) services.
- Trial name
- NCT01903889
- Testing
- clinic based intervention, clinic and community based intervention
- Where
- 7 sites in Uganda
- Volunteers
- 3,806 people, healthy volunteers welcome
- Sponsor
- FHI 360