Clinical trials: Tuberculosis
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
HIV/AIDS, Tuberculosis
Dose Escalation Study to Determine the Pharmacokinetics of Atazanavir Administered With RIfampicin to HIV Positive Adults on sEcond-line ART Regimen With Suppressed HIV-1 Viral Load
The standard treatment for TB consists of rifampicin (RIF) as part of the regimen. However, due to drug-drug interactions (DDI), the bioavailability of PIs is greatly reduced when co-administered with RIF necessitating use of…
- Trial name
- DERIVE (NCT04121195)
- Testing
- Dose escalation
- Where
- Uganda
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Liverpool
Tuberculosis
PPD Size and Mycobacteria Tuberculosis ELISPOT in Children Who Have Received BCG in Neonate Period
To investigate the size of PPD and TB specific ELISPOT among children between 3m/o and 15 y/o . Calculate the normal range of age specific PPD size in children who recieved BCG at new-born period.
- Trial name
- NCT00172783
- Where
- Taiwan
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Hiv, Tuberculosis
Interrupting HIV and TB Stigma in the Household in Uganda
The investigators will carry out a prospective, household cluster-randomized, implementation trial evaluating a complex, multi-component, social and behavioral intervention designed to normalize the acceptance of HIV testing in…
- Conditions
- Hiv, Tuberculosis, Social Behavior, Stigma, Social
- Trial name
- NCT05124665
- Testing
- Social Support
- Where
- Uganda
- Volunteers
- 612 people, healthy volunteers welcome
- Sponsor
- Yale University
Tuberculosis (TB), Tuberculosis Infection, Latent
Screening With Portable X-rays for Rapid Recognition of TB
SPOT-TB (Screening with Portable X-rays for rapid recOgniTion of TB) is a prospective study evaluating a community-based tuberculosis (TB) screening strategy for migrant populations in New York City.
- Conditions
- Tuberculosis (TB), Tuberculosis Infection, Latent, HIV (Human Immunodeficiency Virus)
- Trial name
- SPOT-TB (NCT07737275)
- Testing
- Mobile chest radiography for tuberculosis screening
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Columbia University
Tuberculosis
Multi-Drug Resistant Tuberculosis in Korea
This study, conducted in Korea, will examine why some people are more susceptible to tuberculosis (TB) than others and why some strains of M tuberculosis (the bacteria that causes TB) are more difficult to treat or become…
- Trial name
- NCT00341601
- Where
- 2 sites in South Korea
- Volunteers
- 777 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
Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants
Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and dose-range finding study of AERAS-404 Tuberculosis (TB) vaccine administered intramuscularly in Bacille Calmette-Guerin (BCG) primed infants.
- Trial name
- C-015-404 (NCT01861730)
- Testing
- AERAS-404
- Where
- 4 sites in South Africa
- Volunteers
- 243 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to…
- Trial name
- NCT02378207
- Testing
- H4:IC31, H56:IC31, BCG
- Where
- South Africa
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis
Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-009)
This will be a Phase 1, single-center, randomized, balanced, single-dose, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824.
- Trial name
- CL-009 (NCT01830439)
- Testing
- PA-824 200mg, PA-824 50mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
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
Study of the Safety and Immunogenicity of Bacille Calmette Guerin (BCG) Vaccine
Tuberculosis (TB) kills about three million people annually. It is estimated that one third of the world's population are latently infected with Mycobacterium tuberculosis (M.tb).
- Trial name
- NCT00654316
- Testing
- BCG
- Where
- United Kingdom
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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
Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment
Evaluate the possibility of using an IGRA (Interferon-γ Release Assay) test for monitoring the response to anti-tuberculosis therapy by studying the correlation between the variation in the Interferon-gamma (IFN-γ) response to…
- Trial name
- IGRA/MAT-1 (NCT05724212)
- Testing
- Interferon gamma release assay (IGRA)
- Where
- Italy
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Paola Mantegani
Tuberculosis
A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB
This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential.
- Trial name
- C-010-402 (NCT02414828)
- Testing
- AERAS-402 3 x 10^8 vp, AERAS-402 3 x 10^9 vp, AERAS-402 3 x 10^10 vp
- Where
- South Africa
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Aeras
Multi Drug Resistant Tuberculosis, HIV Infections
An Adaptive Randomized Controlled Trial
This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment…
- Trial name
- ADAP-TIV (NCT05633056)
- Testing
- Adherence support intevention
- Where
- South Africa
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Columbia University
Latent Tuberculosis Infection
Screening for Latent Tuberculosis in Healthcare Workers With Quantiferon-Gold Assay: A Cost-Effectiveness Analysis
The ministry of health in Israel requires all health-care workers to undergo screening for latent Tuberculosis infection (LTBI) prior to starting work. This is based on the Mantoux skin test, which is notoriously unreliable.
- Trial name
- NCT00449345
- Testing
- Blood test for Quantiferon-GOLD assay
- Where
- Israel
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Assuta Hospital Systems
Mycobacterium Tuberculosis
Pharmacokinetic Issues of Moxifloxacin Plus Rifapentine
The purpose of this study is to determine the pharmacokinetics (how a drug is absorbed, distributed, and eliminated by the body) of moxifloxacin alone versus moxifloxacin given with rifapentine.
- Trial name
- NCT00460759
- Testing
- Moxifloxacin, Rifapentine
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Pulmonary TB
Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults
This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and…
- Trial name
- NCT03722472
- Testing
- ID93 + GLA-SE
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Tuberculosis
ID93/GLA-SE Vaccination + BCG Challenge
The purpose of this study is to: 1. Demonstrate the safety of a novel TB vaccine (ID93/GLA-SE) when given to both BCG-vaccinated and BCG-naïve volunteers. 2.
- Trial name
- NCT06670755
- Testing
- ID93/GLA-SE, BCG Danish
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of Oxford