Clinical trials: LTBI
Tuberculosis Infection
Equivalence Study of Specificity of PPD
Determine if investigational products and reference standard produce similar responses.
- Trial name
- 03 (NCT01798095)
- Testing
- Aplisol@ PPD material, Reference Standard
- Where
- United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- JHP Pharmaceuticals LLC
Mycobacterium Tuberculosis Infection
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation)…
- Trial name
- VPM1002 (NCT04351685)
- Testing
- VPM1002, BCG SII
- Where
- 12 sites in Gabon, Kenya and 3 more
- Volunteers
- 6,940 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Tuberculosis
Assessing the Ability of the T-SPOT®.TB Test (IQ)
The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response (NTBSLR) in identifying patients with active TB disease.
- Trial name
- IQ (NCT03973970)
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Oxford Immunotec
Active Tuberculosis, Latent Tuberculosis Infection
Performance Evaluation of the VIDAS TB-IGRA Assay.
This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection.
- Conditions
- Active Tuberculosis, Latent Tuberculosis Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia
- Trial name
- NCT04048018
- Testing
- Blood draw and IGRA test
- Where
- 24 sites in United States, Brazil and 7 more
- Volunteers
- 2,401 people, healthy volunteers welcome
- Sponsor
- BioMérieux
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
- NCT02253537
- Testing
- CST001
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- QIAGEN Gaithersburg, Inc
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 (TB)
Assessing the Ability of the T-SPOT®.TB Test
The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response in identifying patients with active TB disease.
- Trial name
- IQ (NCT03929705)
- Where
- South Africa
- Volunteers
- 676 people
- Sponsor
- Oxford Immunotec
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
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
Tuberculosis Infection
Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).
- Trial name
- NCT01689831
- Testing
- To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard., Reactivity of Aplisol compared to reference standard PPD-S2.
- Where
- United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- JHP Pharmaceuticals LLC
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.
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.
Tuberculosis
Study to Evaluate the Tolerability and Immunogenicity of Nyaditum Resae ® Probiotic Administered to Pediatric Population in Contact With Tuberculosis With or Without Latent Tuberculosis Infection
This is a doble-blind, masked, compared with placebo clinical trial in pediatric population in contact with tuberculosis with or without tuberculosis infection.
- Trial name
- NCT02581579
- Testing
- Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis
- Where
- 3 sites in Spain
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Manresana de Micobacteriologia, SL
Latent Tuberculosis Infection (LTBI)
C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia
This is an operational research in household/close contacts of confirmed TB patients to evaluate the effectiveness of C-TST compared to IGRA test in identifying latent TB cases using parameters of effectiveness and safety.
- Trial name
- C-TST (NCT07587164)
- Testing
- Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)
- Where
- Indonesia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
Clinical Trial to Evaluate the Efficacy and Safety of EEC for the Diagnosis of Mycobacterium Tuberculosis Infection in People Aged 3 Years and Above
This study is a randomized, blinded, active-controlled clinical trial to evaluate the effectiveness and safety of EEC in the diagnosis of Mycobacterium tuberculosis infection in people aged 3 years and above.
- Trial name
- NCT07152639
- Testing
- 5μg/ml EEC, 5 unit（U） EC, 5 IU TB-PPD
- Where
- 8 sites in China
- Volunteers
- 1,784 people, healthy volunteers welcome
- Sponsor
- Chengdu CoenBiotech Co., Ltd
Tuberculosis
Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent Tuberculosis
Mycobacterium Vaccae for Injection (Trade Name "Vaccae") is a kind of bio-products developed by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,and got "The New Drug Certificate "in 1999.
- Trial name
- NCT01979900
- Testing
- Vaccae
- Where
- 4 sites in China
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.
- Trial name
- NCT02687529
- Testing
- CST001
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Tuberculosis
Safety and Immunogenicity of Nyaditum Resae® Probiotic to Protect From Tuberculosis
This is a double-blind, masked, compared with placebo clinical trial in healthy volunteers with or without tuberculosis infection.
- Trial name
- NCT02076139
- Testing
- Nyaditum resae® 10e4, Nyaditum resae® 10e5, Distilled water
- Where
- Spain
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Manresana de Micobacteriologia, SL
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
- NCT02256839
- Testing
- CST_001
- Where
- United States
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
Latent Tuberculosis Infection, Tuberculosis
Clinical Trial to Investigate the Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI® Following One Month of Isoniazid Treatment in Subjects With Latent Tuberculosis Infection
The aim of the trial is to assess the safety, tolerability and immunogenicity of two doses of RUTI® vaccine administered four weeks apart after one month pre-treatment with INH.
- Trial name
- NCT01136161
- Testing
- RUTI
- Where
- 3 sites in South Africa
- Volunteers
- 95 people
- Sponsor
- Archivel Farma S.L.