Clinical trials: BCG Infection
Tuberculosis
Aerosol BCG Challenge Study in Historically BCG-vaccinated Volunteers
The purpose of this study is to evaluate the human clinical response to BCG challenge in historically BCG-vaccinated healthy adult volunteers. It will involve 12 participants in a controlled dose escalation.
- Trial name
- NCT04777721
- Testing
- BCG Danish
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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, HIV Infections
Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults
This was a Phase II, randomized, double-blind, placebo-controlled trial conducted at 1 site in South Africa. A total of 26 subjects were randomized 1:1 to receive 2 doses of either AERAS-402 at 3 x 10^10 vp (N=13) or placebo…
- Trial name
- NCT01017536
- Testing
- AERAS-402
- Where
- South Africa
- Volunteers
- 26 people
- Sponsor
- Aeras
Latent Tuberculosis Bacteriology and Histology Unknown, Latent Tuberculosis
A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)
This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease.
- Trial name
- NCT01865487
- Testing
- H56ug/IC31nmol
- Where
- 2 sites in South Africa
- Volunteers
- 98 people
- Sponsor
- Aeras
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
Cystic Fibrosis, Bronchiectasis Adult
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers.
- Conditions
- Cystic Fibrosis, Bronchiectasis Adult, Non-Tuberculous Mycobacteria
- Trial name
- NCT04884308
- Testing
- BCG TICE Vaccine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Tuberculosis
A Study of MVA85A in Healthy Infants
This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without tuberculosis or HIV infection.
- Trial name
- NCT00953927
- Testing
- MVA85A/AERAS-485, Candida Skin Test Antigen
- Where
- 3 sites in South Africa
- Volunteers
- 2,797 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis, Healthy
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation in inducing protection against tuberculosis…
- Trial name
- MTBVAC (NCT02013245)
- Testing
- MTBVAC live vaccine, Commercially available BCG live vaccine
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Bladder Neoplasm, Neoplasm Recurrence, Local
Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide.
- Conditions
- Bladder Neoplasm, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma, Carcinoma in Situ
- Trial name
- EMBARC-RF (NCT01200992)
- Testing
- EN3348, Mitomycin C
- Where
- 72 sites in United States, Canada and 4 more
- Volunteers
- 84 people
- Sponsor
- Bioniche Life Sciences Inc.
Tuberculosis
Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity.
- Trial name
- NCT05203068
- Testing
- Recombinant tuberculosis allergen (RTA)
- Where
- Russia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Tuberculosis
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
The purpose of the study is to develop a BCG challenge model for use in short term Phase I human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune responses to impact in vivo mycobacterial…
- Trial name
- NCT05592223
- Testing
- BCG Vaccine USP, Isoniazid, Rifampin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
Tuberculosis
Comparative Study of Bacille Calmette Guerin (BCG) Delivery Via Disposable Syringe Jet Injector and Needle & Syringe
The study is designed to test the hypothesis that BCG administration via jet injector will produce a comparable immune response and that there will be no significant differences in safety or reactogenicity between BCG…
- Trial name
- NCT01742364
- Testing
- Bioject ID Pen, Needle and syringe
- Where
- South Africa
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- PATH
Tuberculosis
Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
The purpose of this study is to demonstrate the efficacy of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus…
- Trial name
- NCT04152161
- Testing
- BCG vaccine SSI
- Where
- 5 sites in South Africa
- Volunteers
- 1,836 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Respiratory Syncytial Virus Infections
A Study to Assess Safety, Tolerability and Immunogenicity of the Live Attenuated hRSV Vaccine rBCG-N-hRSV
Human respiratory syncytial virus (hRSV) is the main cause of lower respiratory tract infection in children under one year of age.
- Trial name
- EVA-VRS01 (NCT03213405)
- Testing
- rBCG-N-hRSV 1/100, rBCG-N-hRSV 1/10, rBCG-N-hRSV full dose
- Where
- Chile
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pontificia Universidad Catolica de Chile
Covid19, Non-specific Effects of Vaccines
Using BCG to Protect Senior Citizens During the COVID-19 Pandemic
Background: The virus SARS-CoV-2 has spread rapidly throughout the world. Seniors are at high risk of severe COVID-19 when infected.
- Conditions
- Covid19, Non-specific Effects of Vaccines, Heterologous Immunity, Morbidity
- Trial name
- NCT04542330
- Testing
- BCG-Denmark, Saline
- Where
- Denmark
- Volunteers
- 1,700 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
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
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
Tuberculosis
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to…
- Trial name
- NCT02378207
- Testing
- H4:IC31, H56:IC31, BCG
- Where
- South Africa
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Aeras
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