Clinical trials: BCG Vaccine
Bladder Cancer
Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer
The purpose of this study is to test the safety of avelumab and Bacille Calmette-Guerin (BCG) and see what effects (good and bad) that this combination treatment has on subjects with recurrent bladder cancer.
- Trial name
- OU-SCC-ABC (NCT03892642)
- Testing
- Avelumab, BCG
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Oklahoma
Bladder Carcinoma
Sequential Intravesical Bacillus Calmette-Guérin and Electromotive Mitomycin-C After Transuretheral Resection
The primary objective of the study is to assess the bladder cancer recurrence free rate, according to a phase II pilot study, of intravesical instillation of sequential BCG and EMDA/MMC after TUR.
- Trial name
- NCT02202044
- Testing
- Intravesical BCG and EMDA/MMC
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- University of Colorado, Denver
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
Recurrent Bladder Carcinoma, Stage 0a Bladder Urothelial Carcinoma
Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer
The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of pembrolizumab, when given as a single agent in patients with bladder tumors.
- Conditions
- Recurrent Bladder Carcinoma, Stage 0a Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Cancer
- Trial name
- NCT02808143
- Testing
- BCG Solution, Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Northwestern University
Urinary Bladder Neoplasms
Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)
Background: Non-muscle-invasive bladder cancer is in the early stages. But it usually comes back after treatment. The drugs Vicineum and Durvalumab may help the immune system find and destroy cancer cells.
- Trial name
- NCT03258593
- Testing
- Durvalumab, Vicineum, Acetaminophen
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Cancer Institute (NCI)
Bladder Cancer
Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants
This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, patient reported outcomes (PROs), and preliminary anti-tumor activity of atezolizumab administered by intravenous (IV)…
- Trial name
- NCT02792192
- Testing
- Atezolizumab, Bacille Calmette-Guérin
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Innate Immune Response
γ-irradiated BCG to Train Innate Immunity
Rationale: The live attenuated Bacillus Calmette-Guerin (BCG) vaccine protects against extrapulmonary infection with Mycobacterium tuberculosis and leprosy.
- Trial name
- NCT02259608
- Testing
- BCG vaccine SSI
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
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
Superficial Bladder Cancer
ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC.
- Trial name
- NCT02773849
- Testing
- ADSTILADRIN
- Where
- 34 sites in United States
- Volunteers
- 157 people
- Sponsor
- Ferring Pharmaceuticals
Bladder Cancer
Intravesical BCG Administration to Patients With Invasive Bladder Cancer
Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.
- Trial name
- NCT02365207
- Testing
- BCG strain of Mycobacterium bovis
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
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
Infant Mortality, BCG
Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial
The purpose of this study is to determine whether BCG vaccination shortly after birth can reduce early infant mortality in a rural and an urban setting.
- Trial name
- BCGR (NCT02504203)
- Testing
- BCG-Denmark 1331 (Statens Serum Institute)
- Where
- Guinea-Bissau
- Volunteers
- 2,332 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
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
Metastatic Melanoma
Phase I Study of Intralesional Bacillus Calmette-Guerin (BCG) Followed by Ipilimumab in Advanced Metastatic Melanoma
This was a Phase 1, open-label, dose-escalation, single-center study in patients with histologically confirmed Stage III or IV melanoma and at least 3 metastatic cutaneous or subcutaneous lesions that were suitable and accessible…
- Trial name
- NCT01838200
- Testing
- Bacillus Calmette-Guérin (BCG) vaccine, Ipilimumab, Isoniazid
- Where
- Australia
- Volunteers
- 5 people
- Sponsor
- Ludwig Institute for Cancer Research
Bladder Cancer
A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose…
- Trial name
- NCT02010203
- Testing
- HS-410, BCG
- Where
- 19 sites in United States
- Volunteers
- 104 people
- Sponsor
- Heat Biologics
Melanoma
Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma
The purpose of this study is to determine if treatment with the autologous cellular vaccine, Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage IV malignant melanoma.
- Trial name
- NCT00671554
- Testing
- Melaxin (autologous dendritoma vaccine) and BCG
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Prisma Health-Upstate
Urothelial Carcinoma Bladder, Bladder Cancer
Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer
A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC).
- Trial name
- GEMDOCE (NCT04386746)
- Testing
- Gemcitabine, Docetaxel
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Non-muscle Invasive Bladder Cancer
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer.
- Trial name
- CREST (NCT04165317)
- Testing
- PF-06801591, Bacillus Calmette-Guerin
- Where
- 196 sites in United States, Australia and 12 more
- Volunteers
- 1,068 people
- Sponsor
- Pfizer