Clinical trials: Tuberculosis Prevention
Tuberculosis
Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents
Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents
- Trial name
- NCT02075203
- Testing
- AERAS-404, Bacillus Calmette-Guérin (BCG)
- Where
- 2 sites in South Africa
- Volunteers
- 989 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis, HIV Infections
Investigational Vaccine for the Prevention of Disseminated Tuberculosis in HIV Infected People
A significant number of HIV infected patients in Africa also have disseminated tuberculosis (infection throughout multiple organs). This type of tuberculosis is a significant cause of mortality in these patients.
- Trial name
- NCT00052195
- Testing
- SRL-172
- Where
- Tanzania
- Volunteers
- 1,975 people, healthy volunteers welcome
- Sponsor
- Dartmouth-Hitchcock Medical Center
Tuberculosis
Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.
An open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of Japanese (Tokyo) 172 BCG, in the prevention of…
- Trial name
- NCT00242047
- Testing
- Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG).
- Where
- South Africa
- Volunteers
- 12,000 people, healthy volunteers welcome
- Sponsor
- University of Cape Town
Kidney Transplant Infection, Tuberculosis
The Prophylaxis of Tuberculosis According to TSPOT Results After Kidney Transplantation
Organ transplant recipients are a high incidence group of tuberculosis infection, and the incidence rate is 7-27 times that of the general population.
- Conditions
- Kidney Transplant Infection, Tuberculosis, Isoniazid Toxicity
- Trial name
- PTTKT (NCT05249699)
- Testing
- Isoniazid, without any additional anti-tuberculosis treatment
- Volunteers
- 303 people
- Sponsor
- West China Hospital
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
Autoimmune Rheumatic Diseases, Prevention
Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases
This is a prospective, randomized, controlled study designed to evaluate the effectiveness of annual re-screening for tuberculosis infection (TBI) (previous) in patients with autoimmune rheumatic diseases (ARDs) receiving…
- Trial name
- TB-RESCREEN (NCT07731672)
- Testing
- re-screening, No Rescreening
- Where
- Brazil
- Volunteers
- 1,660 people
- Sponsor
- University of Sao Paulo General Hospital
HIV Seropositivity, Tuberculosis
Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients
A multicenter, randomized, stratified, open-label, phase IV trial among HIV-positive persons (PLHIV) on antiretroviral therapy (ART), or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary tuberculosis…
- Conditions
- HIV Seropositivity, Tuberculosis, Household Contact
- Trial name
- 1 to 3 (NCT05118490)
- Testing
- Daily rifapentine and isoniazid for 4 weeks, Weekly rifapentine and isoniazid for 12 weeks
- Where
- 4 sites in India, Indonesia and 2 more
- Volunteers
- 1,000 people
- Sponsor
- The Aurum Institute NPC
Tuberculosis, Pulmonary
Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline
The goal of this clinical trial is to assess the efficacy(effectiveness) of doxycycline, a potent inhibitor of matrix metalloproteinase (lung collagenase) activity in prevention of Tuberculosis associated lung fibrosis and…
- Trial name
- TALF-TB (NCT06477185)
- Testing
- Doxycycline
- Where
- 2 sites in Uganda
- Volunteers
- 200 people
- Sponsor
- Makerere University
HIV Infection, Tuberculosis
Prevention of Early Mortality by Presumptive Tuberculosis (TB) Treatment
This study investigates the prevention of early mortality in patients initiating antiretroviral therapy (ART) in sub-Saharan Africa where 79% of the co-infected cases of TB reside.
- Trial name
- PrOMPT (NCT01417988)
- Testing
- Experimental: Empiric TB treatment, ART only arm
- Where
- 3 sites in Gabon, Mozambique and 1 more
- Volunteers
- 44 people
- Sponsor
- Prof JMA Lange
Tuberculosis Infection, Latent, Tuberculosis Active
SCAF-TB - Saving Children and Their Families From Tuberculosis: Implementation Research to Improve TB Preventive Treatment Initiation and Completion Rates Among Contact Persons in Tajikistan and Tanzania
The SCAF-TB study aims to evaluate how the WHO-endorsed SIILTIBCY skin test can be best implemented to test close contacts for tuberculosis infection (TBI) in Tajikistan and Tanzania, either facility-based or home-based delivered…
- Conditions
- Tuberculosis Infection, Latent, Tuberculosis Active, TPT
- Trial name
- SCAF-TB (NCT07714707)
- Testing
- CY-TB Patch, Audiblehealth DX
- Where
- 2 sites in Tajikistan, Tanzania
- Volunteers
- 880 people, healthy volunteers welcome
- Sponsor
- KNCV Tuberculosis Foundation
Tuberculosis
Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac
This study is a multicenter, double-blind, randomized, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of the GamTBvac recombinant subunit tuberculosis vaccine for the prevention of active…
- Trial name
- NCT04975737
- Testing
- GamTBvac
- Where
- Russia
- Volunteers
- 9,500 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Malignant Neoplasms, Tuberculosis (TB)
Prophylaxis of Complications of Basic Therapy Using Naderin in Socially Significant Diseases
This interventional study evaluated the efficacy of Naderin (sodium nucleinate) for the prophylaxis of complications during basic therapy and medical rehabilitation in patients with socially significant diseases, including…
- Conditions
- Malignant Neoplasms, Tuberculosis (TB), HEPATITIS C (HCV)
- Trial name
- NADERIN-SSD (NCT07671508)
- Testing
- Naderin, Standard Therapy
- Volunteers
- 75 people
- Sponsor
- MIPO Clinic
Latent Tuberculosis
Vitamin D Supplementation in TB Prevention
The goal of this clinical trial is to determine whether vitamin D supplementation reduces risk of acquiring latent tuberculosis infection (LTBI) in school age children in Mongolia.
- Trial name
- NCT02276755
- Testing
- Cholecalciferol (vitamin D3)
- Where
- Mongolia
- Volunteers
- 8,851 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Lung Diseases, Tuberculosis
Tuberculosis Prophylaxis in the Homeless--A Controlled Trial
To conduct a three-arm, randomized controlled trial of methods to improve adherence to biweekly directly observed prophylaxis (DOPT) for tuberculosis in homeless adults in San Francisco.
- Trial name
- NCT00005737
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Kidney Transplantation, Tuberculosis
Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients
Tuberculosis (TB) is a major and severe opportunistic infection among solid organ transplant recipients. Chemoprophylaxis is advised for those with latent tuberculosis infection (LTBI).
- Conditions
- Kidney Transplantation, Tuberculosis, Isoniazid Toxicity
- Trial name
- NCT06512831
- Testing
- Isoniazid
- Where
- China
- Volunteers
- 1,348 people
- Sponsor
- West China Hospital
Tuberculosis
Study of AERAS-402 in Healthy Infants
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
- Trial name
- NCT01198366
- Testing
- AERAS-402 1.5 x 10^10 vp, AERAS-402 3.0 x 10^10 vp, AERAS-402 1.0 x 10^11 vp
- Where
- 7 sites in Kenya, Mozambique and 1 more
- Volunteers
- 487 people, healthy volunteers welcome
- Sponsor
- Aeras
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, MDR
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among…
- Trial name
- PHOENIx MDR-TB (NCT03568383)
- Testing
- Delamanid (DLM), Isoniazid (INH), Pyridoxine (vitamin B6)
- Where
- 31 sites in Botswana, Brazil and 11 more
- Volunteers
- 5,832 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Latent Tuberculosis Infection, Infection in Solid Organ Transplant Recipients
"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients".
A multicenter, prospective, non-inferiority, randomized and open clinical trial comparing levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients eligible for liver transplantation.
- Trial name
- FLISH-ILT (NCT01761201)
- Testing
- Levofloxacin, Isoniazid
- Where
- 18 sites in Spain
- Volunteers
- 68 people
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Tuberculosis
Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers
The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two…
- Trial name
- NCT00922363
- Testing
- 50 µg Ag85B-ESAT-6 alone, 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01, 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
- Where
- Netherlands
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut