Clinical trials: Tuberculosis Infection
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.
This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.
- Trial name
- NCT00707967
- Testing
- GSK's candidate Mycobacterium tuberculosis vaccine 692342, Control vaccine with the adjuvant system., Control vaccine with physiological saline
- Where
- Switzerland
- Volunteers
- 37 people
- Sponsor
- GlaxoSmithKline
Tuberculosis
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK2556286 in Healthy Adult Participants
This first time in human (FTIH) study assesses the safety, tolerability, and pharmacokinetics (PK) of single and multiple increasing doses of GSK2556286.
- Trial name
- NCT04472897
- Testing
- GSK2556286
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pulmonary Tuberculosis
Study on the Use of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary Tuberculosis
The purpose of this study is to evaluate the efficacy and tolerability of the complex therapy of drug-resistant respiratory tuberculosis using the drug Ingaron, a lyophilisate for the preparation of a solution for injection for…
- Trial name
- NCT05359315
- Testing
- Interferon-Gamma
- Where
- Russia
- Volunteers
- 84 people
- Sponsor
- SPP Pharmaclon Ltd.
Tuberculosis
Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison to BCG in Healthy Volunteers in South Africa
Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis (TB) for residents in endemic areas…
- Trial name
- NCT01113281
- Testing
- VPM1002 live vaccine, commercially available live vaccine BCG
- Where
- South Africa
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
Tuberculosis (TB)
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and…
- Trial name
- MTBVACph2 (NCT06997367)
- Testing
- MTBVAC, BCG Sii
- Where
- 2 sites in India
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Clinical Trial of MK-8527 and Rifampin in Adult Participants With Latent Tuberculosis Infection (MK-8527-019)
Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given together with rifampin.
- Trial name
- NCT07600775
- Testing
- MK-8527, Rifampin
- Volunteers
- 14 people
- Sponsor
- Merck Sharp & Dohme LLC
Tuberculosis
Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2 Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer Inc) with equivalent dose of the reference Rimactane®…
- Trial name
- NCT01311505
- Testing
- Myrin© 2 (Rifampicin + Isoniazid), Rimactane® (Rifampicin)
- Where
- Philippines
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
The objective of this project is to demonstrate safety, immunogenicity and improved efficacy of the new live attenuated M. tuberculosis vaccine called MTBVAC in a Phase 3 efficacy trial in HIV-uninfected infants born to…
- Trial name
- MTBVACN3 (NCT04975178)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 7,120 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Tuberculosis
Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Choose healthy subjects and patients with TB, distribute them into different dose groups according to the recombinant EC allergen dose from low to high average.
- Trial name
- NCT02329730
- Testing
- 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative, 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative, 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab in Brazil
This was a retrospective observational study that relied on data extracted from patient's chart review at the participating centers.
- Trial name
- ToBeReal (NCT06715254)
- Where
- United States
- Volunteers
- 152 people
- Sponsor
- Novartis Pharmaceuticals
Latent Tuberculosis Infection
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients.
- Trial name
- NCT05746611
- Testing
- Recombinant Mycobacterium tuberculosis fusion protein for injection, TB-PPD was injected
- Where
- China
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
BCG Vaccination Reaction, Tuberculosis
A Study of GC3107(BCG Vaccine) in Healthy Infants
The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants
- Trial name
- NCT03947138
- Testing
- GC3107, Intradermal BCG SSI inj.
- Where
- 2 sites in South Korea
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Tuberculosis
A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
The safety, tolerability and immunogenicity of lyophilized recombinant tuberculosis vaccine (AEC/BC02) were studied in a randomized, blind, controlled phase ⅱ A clinical study in patients 18 years and older with latent infection…
- Trial name
- NCT05284812
- Testing
- Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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.
Rifampicin Susceptible Pulmonary Tuberculosis
Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis
A Phase 2, Single-Centre, Open-Label, Parallel Control Arm, Randomised Clinical Study to Evaluate the Early Bactericidal Activity (EBA), Safety and Tolerability of Nebulised RESP301 in Adults with Newly Diagnosed, Rifampicin…
- Trial name
- NCT06041919
- Testing
- RESP301, HRZE
- Where
- South Africa
- Volunteers
- 20 people
- Sponsor
- Thirty Respiratory Limited
Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB
A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)
This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).
- Trial name
- NCT03563599
- Testing
- Telacebec (Q203), Rifafour e-275
- Where
- 2 sites in South Africa
- Volunteers
- 60 people
- Sponsor
- Qurient Co., Ltd.
Pulmonary Tuberculoses
Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in Tuberculosis
A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
- Trial name
- NCT07073638
- Testing
- RESP30TB, HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)
- Where
- South Africa
- Volunteers
- 24 people
- Sponsor
- Thirty Respiratory Limited
Tuberculosis
A Study to Evaluate the Safety and Immunogenicity of Ad5-105K in Adults Aged 18 to 49 Years
This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups (Group A and B). In each treatment group, 18 participants will be randomly assigned to receive either the investigational vaccine…
- Trial name
- NCT06732583
- Testing
- Tuberculosis (TB) vaccine (Ad5-105K), Ad5-105K
- Where
- Indonesia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Tuberculosis
Evaluation of the QuantiFERON-TB Test.
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
- Trial name
- NCT02142894
- Testing
- CST001
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- QIAGEN Gaithersburg, Inc