Clinical trials: Mycobacterium Infections
Tuberculosis
Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis.
The study is aimed to evaluate the safety and immunogenicity of the medicinal product "GamTBvac" - a recombinant subunit vaccine against the tuberculosis.
- Trial name
- GamTBvac (NCT03255278)
- Testing
- Single GamTBvac vaccination (0.25 dose), Double GamTBvac vaccination (0.25 dose), Double GamTBvac vaccination (0.5 dose)
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Tuberculosis
Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity.
- Trial name
- NCT05203068
- Testing
- Recombinant tuberculosis allergen (RTA)
- Where
- Russia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Tuberculosis, HIV
Evaluation of the Effect of 3HP vs Periodic 3HP vs 6H in HIV-Positive Individuals
This study is a parallel, two part, open label, individually randomized, pragmatic trial among HIV-positive individuals. Part A compares a single round of weekly high dose rifapentine plus isoniazid for three months (3HP) to six…
- Trial name
- WHIP3TB (NCT02980016)
- Testing
- rifapentine + isoniazid, Isoniazid
- Where
- South Africa
- Volunteers
- 4,027 people, healthy volunteers welcome
- Sponsor
- The Aurum Institute NPC
HIV/AIDS
Swaziland HIV Incidence Measurement Survey 2
The second Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016), is a population based HIV Impact Assessment (PHIA) that will assess the prevalence of key human immunodeficiency virus (HIV)-related health indicators.
- Trial name
- SHIMS2 (NCT04117984)
- Where
- Eswatini
- Volunteers
- 15,429 people, healthy volunteers welcome
- Sponsor
- Columbia University
Covid-19 Pandemics, Tuberculosis
Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients
This study is a non-randomized observation and comparison of immune response between bacteriologically confirmed TB patients under treatment cohort who received COVID-19 vaccine (n=54) vs healthy individuals (n=54).
- Trial name
- CVTB (NCT05571735)
- Testing
- Pfizer-BioNTech COVID-19 vaccine, AstraZeneca vaccine, Janssen Ad26.COV2.S COVID-19 vaccine
- Where
- Thailand
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed with BCG to determine if immunization reduces the risk of TB infection
- Trial name
- DAR-PIA (NCT02712424)
- Testing
- DAR-901
- Where
- Tanzania
- Volunteers
- 625 people, healthy volunteers welcome
- Sponsor
- Dartmouth-Hitchcock Medical Center
Tuberculosis
Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65(III-healthy)
The investigators recruit about 1800 cases participants who has signed ICF,then do some physical examinations for these people, including ecg, X-ray, HIV,blood pressure, specific gamma-interferon detection ,collection of medical…
- Trial name
- NCT02795260
- Testing
- Bacillus Calmette - Guerin
- Volunteers
- 1,802 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis, Hiv
A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects
This is a single-center, open-label, fixed sequence, pharmacokinetic interaction study between bictegravir and tenofovir alafenamide with rifapentine dosed either daily or weekly.
- Trial name
- NCT04551573
- Testing
- Rifapentine daily, Rifapentine weekly
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Yale University
Latent Tuberculosis, Active Tuberculosis
Improving the Detection of Active Tuberculosis in Accident and Emergency Departments
Tuberculosis (TB) control remains a public health challenge. Many people in the UK do not have a general practitioner (GP) registration and their only interaction with the NHS is via Accident and Emergency (A\&E) Departments of…
- Trial name
- ACE (NCT02512484)
- Testing
- venepuncture, sputum collection, xray
- Where
- 3 sites in United Kingdom
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Public Health England
Tuberculosis, Tuberculosis, Pulmonary
Effect of Integrating Traditional Tuberculosis Care With Modern Health Care on Case Detection
Although many interventions are implemented to increase TB case detection, decrease diagnosis delay, and avoid catastrophic costs, there are no significant changes and the end TB goal will not be achieved in 2035.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis Infection
- Trial name
- NCT05236452
- Testing
- Training for traditional and modern care providers
- Where
- Ethiopia
- Volunteers
- 918 people, healthy volunteers welcome
- Sponsor
- Bahir Dar University
Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years.
- Trial name
- NCT07762014
- Testing
- Vaccination with rBCG-N-RSV, Vaccination with conventional BCG (BCG-WT)
- Where
- Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Biothervax SpA
Tuberculosis
Predictive Values of Next Generation Interferon Gamma Release Assays for Latent Tuberculosis Infection
This study will assess the next generation of blood tests for latent TB infection, which may be able to indicate how treatment is working as well as in diagnosis infection.
- Trial name
- NextGen (NCT02512939)
- Testing
- blood test, not yet marketed, no trade name
- Where
- 5 sites in United Kingdom
- Volunteers
- 675 people, healthy volunteers welcome
- Sponsor
- University College, London
Substance-Related Disorders, Mental Disorder
Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa
Poor engagement in care contributes to HIV- and TB-related morbidity and mortality in South Africa (SA). Community health workers (CHWs) are frontline lay health workers who work to re-engage patients who are lost to follow-up…
- Conditions
- Substance-Related Disorders, Mental Disorder, Social Stigma, Depression
- Trial name
- Siyakhana (NCT05282173)
- Testing
- Siyakhana CHW Training
- Where
- South Africa
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of Maryland, College Park
Tuberculosis, Tuberculosis (TB)
Questioning the Epidemiology of Asymptomatic TB
Tuberculosis (TB) remains one of the world's leading causes of morbidity and mortality. Current TB control strategies focus largely on the binary paradigm of TB, which tackle Mtb infection and the symptomatic stages of the…
- Conditions
- Tuberculosis, Tuberculosis (TB), HIV, HIV (Human Immunodeficiency Virus)
- Trial name
- TB QUEST (NCT07312266)
- Where
- Mozambique
- Volunteers
- 6,770 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
Tuberculosis
A Study to Quantify Bacille Calmette Guerin (BCG) and Characterise the Immune Response After BCG Vaccination
This is a human pilot study of 16 healthy BCG-naïve volunteers to quantify BCG from the BCG vaccination site. Volunteers will be vaccinated with BCG.
- Trial name
- NCT00653627
- Testing
- BCG
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis, Healthy
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation in inducing protection against tuberculosis…
- Trial name
- MTBVAC (NCT02013245)
- Testing
- MTBVAC live vaccine, Commercially available BCG live vaccine
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Multidrug Resistant Tuberculosis
MDR-TB Close Contacts Tracing in China (TCCT Study)
To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.
- Trial name
- NCT04484129
- Where
- 8 sites in China
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Huashan Hospital
Tuberculosis
Study Evaluating Aerosol and Intradermal Administration of a Candidate Tuberculosis (TB) Vaccine, MVA85A, as a Way to Increase Immune Response and Avoid Anti-vector Immunity
Boost vaccinations sometimes have no effect because the body has got used to the vaccine and no longer reacts to it. We are therefore investigating whether vaccinating with aerosolised MVA85A (a candidate tuberculosis vaccine)…
- Trial name
- NCT01954563
- Testing
- MVA85A
- Where
- United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
Phase 2a Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Healthcare Workers
The purpose of this study is to evaluate the experimental tuberculosis (TB) vaccine called ID93+GLA-SE. The safety, immunogenicity, and efficacy of ID93+GLA-SE will be compared to placebo, after three intramuscular (IM)…
- Trial name
- NCT03806686
- Testing
- ID93+GLA-SE
- Where
- 3 sites in South Korea
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
Tuberculosis
Safety Study of ChAdOx1 85A Vaccination With and Without MVA85A Boost in Healthy Adults
This is a Phase I trial to evaluate the safety and immunogenicity of a ChAdOx1 85A vaccination with and without MVA85A boost in healthy BCG vaccinated adults.
- Trial name
- NCT01829490
- Testing
- ChAdOx1 85A, MVA85A
- Where
- 2 sites in United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University of Oxford