Clinical trials: Tuberculosis
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
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
Latent Tuberculosis Infection
Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above
A multicenter, randomized, blind, controlled trial design was used to select 240 tuberculosis (TB) patients, 120 non-tuberculous community population with other lung diseases, and 420 healthy community population without other…
- Trial name
- NCT05899179
- Testing
- Recombinant Mycobacterium Tuberculosis Fusion Protein, Purified Protein Derivative of Tuberculin
- Where
- 8 sites in China
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
The Correlate of Risk Targeted Intervention Study
Effective tuberculosis (TB) control requires that people who progress from latent Mycobacterium tuberculosis (MTB) infection (LTBI) to TB disease are identified and treated before they infect others.
- Trial name
- CORTIS (NCT02735590)
- Testing
- Isoniazid, Rifapentine
- Where
- 5 sites in South Africa
- Volunteers
- 2,927 people, healthy volunteers welcome
- Sponsor
- University of Cape Town
Tuberculosis
Vitamin D Supplementation Enhances Immune Response to Bacille-Calmette-Guerin (BCG) Vaccination in Infants
The purpose of this study is to determine whether a single oral dose of vitamin D given to infants prior to Bacille-Calmette-Guerin (BCG) vaccination will enhance the immune response to BCG vaccination.
- Trial name
- BCG-25-D (NCT01288950)
- Testing
- Vitamin D3 (cholecalciferol)
- Where
- Mexico
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Renal Impairment, Tuberculosis
Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function
This is a Phase 1, open-label, single-dose, sequential group study to compare the safety and pharmacokinetics (PK) of pretomanid in the following groups of participants: 1) participants with severe renal impairment including…
- Trial name
- NCT03896750
- Testing
- PA-824
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
A Study of MVA85A in Healthy Children and Infants
This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and highly immunogenic in a wide range of subjects…
- Trial name
- NCT00679159
- Testing
- MVA85A, Prevenar
- Where
- South Africa
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis, Health Care Professionals
Study of Health Personnel and the Assistance to Patients With Tuberculosis in Hospital Environment
The purpose of this study is to evaluate in hospital environment the knowledge of the health care professionals about fundamental concepts on tuberculosis and the accomplishment to respiratory isolation practices for patients…
- Conditions
- Tuberculosis, Health Care Professionals, Hospital Environment
- Trial name
- NCT00978510
- Where
- Brazil
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Sociedade Cearense de Infectologia
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 Infection, Tuberculosis Prevention
Qualitative Understanding of Community TB Services Pre and Post the CHIP-TB Trial
This qualitative study is designed to elicit the perspectives of relevant stakeholders to adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention treatment (TPT) initiation for child TB contacts…
- Trial name
- NCT04494516
- Where
- 2 sites in Ethiopia, South Africa
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Tuberculosis
Evaluating the Pharmacokinetics of High-Dose Rifapentine When Given as a Single Dose or in Divided Doses to Healthy Adults
This study will evaluate two different ways to give rifapentine (RPT), a drug that may help shorten treatment duration for tuberculosis (TB) disease.
- Trial name
- NCT01574638
- Testing
- Rifapentine (RPT)
- Where
- 4 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Latent Tuberculosis Infection
Clinical Trial of Mica
This study used a randomized, open, blank control design. A total of 6800 patients over 15 years old with latent mycobacterium tuberculosis infection who met the inclusion criteria but did not meet the exclusion criteria were…
- Trial name
- NCT05680415
- Testing
- Mycobacterium Vaccae for Injection
- Where
- 2 sites in China
- Volunteers
- 6,800 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
Evaluation of an Enhanced Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand
Study Design: Stratified, matched, cluster-randomized, controlled trial Unit of Randomization: Healthcare facility Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare workers (HCWs) will be…
- Trial name
- EnTIC (NCT02073240)
- Testing
- Enhanced TB IC Package
- Where
- 22 sites in Thailand, Vietnam
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Pulmonary Tuberculosis
Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.
- Trial name
- NCT01599897
- Testing
- ID93 + GLA-SE, ID93 alone
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Tuberculosis, Iron Deficiency Anemia
Universal Screening for Tuberculosis and Anemia With the CHICA System
The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians.
- Trial name
- NCT01322841
- Testing
- CHICA Diagnosis Module
- Where
- United States
- Volunteers
- 2,239 people, healthy volunteers welcome
- Sponsor
- Indiana University
Pulmonary Tuberculosis, Hypoalbuminemia
I-FALMIN Albumin Supplement for Patients With Pulmonary Tuberculosis
This study evaluates the potential of I-FALMIN, a supplement derived from toman fish (Channa micropeltes), as an additional source of albumin in patients with pulmonary tuberculosis.
- Trial name
- I-FALMIN TB (NCT07186478)
- Testing
- Investigational Drug
- Where
- Indonesia
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Hasanuddin University
Tuberculosis
A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.
This study is a Phase 1, single-center, open-label, single-dose study to evaluate (1) the absorption, metabolism, and excretion patterns of a single dose of [14C] PA-824, and (2) the pharmacokinetics, safety, and tolerability of…
- Trial name
- CL-004 (NCT03202693)
- Testing
- PA-824
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Latent Tuberculosis, Latent Tuberculosis Bacteriology and Histology Unknown
Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis
This is a Phase I, open-label, dose-escalation study with three study groups. This study will be conducted in 25 HIV negative subjects, 17 of whom will have Latent Tuberculosis Infection (LTBI) and 8 of whom will not have LTBI at…
- Trial name
- NCT01967134
- Testing
- H56:IC31
- Where
- South Africa
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis Infection
Evaluation of ТВ/Flu-05Е Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years
The aim of the study is to investigate safety, reactogenicity and immunogenicity of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years.
- Trial name
- NCT05945498
- Testing
- TB/Flu-05E vaccine
- Where
- Russia
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Tatyana Zubkova
Tuberculosis
Investigating Immune Responses to Aerosol BCG Challenge in Healthy UK Adults
TB043 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive (Group 1-7) as well as historically BCG vaccinated UK adults (Group 8) .
- Trial name
- NCT03912207
- Testing
- BCG Danish
- Where
- 2 sites in United Kingdom
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- University of Oxford