Clinical trials: BCG
HIV Exposure, HIV Infection
Early Versus Delayed BCG Vaccination of HIV-exposed Infants
In sub-Saharan Africa (SSA), more than 300,000 babies with HIV die each year. HIV-infected children develop AIDS and die faster in SSA than those in developed countries.
- Trial name
- NCT02062580
- Testing
- BCG
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- University of Cape Town
Prevention of TB Recurrence
Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence
This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo.
- Trial name
- NCT03152903
- Testing
- VPM1002 (Recombinant BCG Vaccine)
- Where
- 10 sites in Bangladesh, India
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Tuberculosis
A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 Administered in Adults
This Phase I study will be conducted as a randomized, double-blind, dose-escalation study in five groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis…
- Trial name
- NCT02074956
- Testing
- AERAS-404
- Where
- Finland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Aeras
Infant Morbidity, Infant Mortality
BCG Revaccination With the Third Dose of Diphtheria-tetanus-pertussis Vaccine and Infant Mortality in Africa
Studies in low-income countries show that vaccines can have important non-specific effects on other infections. Live BCG vaccine can train the immune system and reduce susceptibility to unrelated infections.
- Conditions
- Infant Morbidity, Infant Mortality, Non-Specific Effects of Vaccines, BCG
- Trial name
- BCG2-DTP3 (NCT07005726)
- Testing
- BCG Vaccine
- Where
- Guinea-Bissau
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Sepsis
Effects of BCG on Immune Response
In the present study, we want to investigate whether BCG-vaccination enhances the innate immune response in humans in vivo during (single) human endotoxemia.
- Trial name
- NCT02085590
- Testing
- BCG vaccine, Lipopolysaccharide (LPS) E. Coli 1 ng/kg intravenously
- Where
- Netherlands
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
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
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- Trial name
- RESCUE (NCT07342517)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Relmada Therapeutics, Inc.
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
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
BCG, COVID-19
Prevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare Workers
In Mexico the total number of confirmed cases of COVID-19 is 232, 000 and 28,510 deaths. Health workers are at high risk of COVID-19 infection. Their absence from work dramatically limits the ability to contain the disease.
- Conditions
- BCG, COVID-19, SARS-CoV2, Corona Virus Infection
- Trial name
- NCT04461379
- Testing
- BCG vaccine
- Where
- Mexico
- Volunteers
- 908 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
BCG Vaccination Reaction
Safety and Tuberculin Conversion Following BCG Vaccination
The study is an bridging study, observer-blind, randomized, controlled prospective intervention study. The primary objective is evaluate the safety of BCG Vaccine Vial (Bio Farma).
- Trial name
- NCT05124340
- Testing
- BCG vial vaccine, BCG ampoule vaccine
- Where
- Indonesia
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
COVID-19
Reducing COVID-19 Related Hospital Admission in Elderly by BCG Vaccination
Bacillus Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has also been shown to induce protection against various infections with a viral aetiology, leading to significant reductions in morbidity and…
- Trial name
- NCT04417335
- Testing
- BCG vaccine
- Where
- 2 sites in Netherlands
- Volunteers
- 2,014 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Bladder Cancer
PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer
Approximately 25 subjects will be enrolled and receive a standard WHO adult potency BCG immunization (1cc/50mg live mycobacilli) in the deltoid.
- Trial name
- NCT02326168
- Testing
- Bacillus Calmette-Guerin (BCG)
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center at San Antonio
Tuberculosis
Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults
Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI…
- Trial name
- MTBVAC-Ph1b (NCT02729571)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Healthy
Safety/Efficacy Trial of Killed Leishmania Vaccine in Volunteers With Positive Response to Leishmanin (LST>0)
Development of a safe and effective vaccine against leishmaniasis started more than 10 years ago under WHO/TDR supervision. An autoclaved L. major vaccine (ALM) mixed with BCG has been tested in human in Iran, Pakistan and Sudan.
- Trial name
- NCT00429780
- Testing
- Alum-ALM + BCG
- Where
- Iran
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Tehran University of Medical Sciences
Type 1 Diabetes Mellitus
Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics
Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the pancreas. The investigators have discovered the specific autoimmune cells responsible for destroying the insulin-producing cells in an…
- Trial name
- NCT00607230
- Testing
- BCG, Saline
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Morbidity, Bacille Calmette-Guérin
Trial of Two Strains of BCG
The investigators aim to conduct a randomised controlled trial comparing two Bacille Calmette-Guérin (BCG) strains currently used in Guinea-Bissau, the Danish and the Russian, in terms of prevention of neonatal and early life…
- Trial name
- BCGSTRAIN (NCT02447536)
- Testing
- BCG-Denmark 1331 (Statens Serum Institute), BCG-Russia-I (Serum Institute of India)
- Where
- Guinea-Bissau
- Volunteers
- 12,006 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Coronavirus, Coronavirus Infection
BCG Vaccine for Health Care Workers as Defense Against COVID 19
SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW).
- Conditions
- Coronavirus, Coronavirus Infection, Coronavirus as the Cause of Diseases Classified Elsewhere
- Trial name
- BADAS (NCT04348370)
- Testing
- BCG Vaccine
- Where
- 6 sites in United States
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- Texas A&M University
COVID-19, Non-specific Effects of Vaccines
Using BCG Vaccine to Protect Health Care Workers in the COVID-19 Pandemic
Background: The COVID-19 pandemic challenges the available hospital capacity, and this will be augmented by absenteeism of healthcare workers (HCW).
- Conditions
- COVID-19, Non-specific Effects of Vaccines, Morbidity, Absenteeism
- Trial name
- NCT04373291
- Testing
- BCG-Denmark, Saline
- Where
- Denmark
- Volunteers
- 1,293 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Death, Infant, Morbidity;Infant
Trial to Compare Two Strains of BCG
The trial will be a two-year outcome assessor-blinded RCT at the maternity ward of hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare BCG-Japan versus BCG-Russia 1:1 in 15,000 infants with respect to…
- Trial name
- STRAIN III (NCT04383925)
- Testing
- BCG-Japan, BCG-Russia
- Where
- Guinea-Bissau
- Volunteers
- 16,390 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project