Clinical trials: Bacillus-Calmette-Guerin
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
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
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers
This is a two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study. This study will evaluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to…
- Trial name
- NCT05547464
- Testing
- BNT164a1, BNT164b1
- Where
- 8 sites in Mozambique, South Africa
- Volunteers
- 497 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Bladder Cancer
A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer
The efficacy and safety of IAP0971 single drug or combined with BCG intravesical instillation in the treatment of high-risk non muscle invasive bladder cancer with BCG treatment failure.
- Trial name
- NCT06255964
- Testing
- IAP0971, IAP0971＋BCG
- Volunteers
- 236 people
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Multiple Sclerosis
Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)
Multiple sclerosis (MS) witnessed relevant therapeutic progress in the last decade. Following the extraordinary progress in the treatment of relapsing-remitting (RR) multiple sclerosis (MS), two major unmet needs remain to be…
- Trial name
- NCT03888924
- Testing
- Bacille Calmette-Guerin vaccine
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- S. Andrea Hospital
Tuberculosis
Clinical Study of BCG Vaccine for Intradermal Injection
The study used a randomized, dose-escalation, blinded, placebo-controlled trial design. In this trial, 160 subjects were enrolled.
- Trial name
- NCT04563273
- Testing
- BCG vaccine 1（0.025mg/0.1ml/person）, BCG vaccine 2 （0.05mg/0.1ml/person）, BCG vaccine 3（0.075mg/0.1ml/person）
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Bladder Cancer
BCG With or Without Gefitinib in Treating Patients With High-Risk Bladder Cancer
RATIONALE: Biological therapies, such as BCG, may stimulate the immune system in different ways and stop tumor cells from growing.
- Trial name
- NCT00352079
- Testing
- BCG vaccine, gefitinib, quality-of-life assessment
- Where
- 6 sites in Canada
- Volunteers
- 41 people
- Sponsor
- NCIC Clinical Trials Group
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
Covid19, BCG Vaccination Reaction
Clinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in Poland
Countries that have not carried out universal mass vaccination against tuberculosis (BCG) have been shown to have higher incidence and death rates due to COVID-19 than countries with mass, long-term BCG immunization programmes.
- Conditions
- Covid19, BCG Vaccination Reaction, SARS-CoV Infection
- Trial name
- NCT04648800
- Testing
- BCG-10 vaccine, 0.9% saline
- Where
- 6 sites in Poland
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Hanna Czajka
Bladder Cancer
S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00234039
- Testing
- gemcitabine hydrochloride
- Where
- 98 sites in United States
- Volunteers
- 58 people
- Sponsor
- SWOG Cancer Research Network
Bladder Cancer
A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer
This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.
- Trial name
- NCT02753309
- Testing
- Sirolimus
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Tuberculosis, Healthy
Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison With BCG in Healthy Male Volunteers
Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against TB for residents in endemic areas and persons at…
- Trial name
- NCT00749034
- Testing
- VPM1002, BCG
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
Nonmuscle-invasive Bladder Cancer
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
This is a Phase II clinical study to evaluate the efficacy and safety of intravesical T3011 injection in participants with BCG-unresponsive high-risk NMIBC or BCG-exposed, chemotherapy-unresponsive intermediate/high-risk NMIBC.
- Trial name
- NCT06971614
- Testing
- T3011
- Where
- 9 sites in United States
- Volunteers
- 160 people
- Sponsor
- ImmVira Pharma Co. Ltd
Bladder Cancer, Non-Muscle Invasive Bladder Cancer (NMIBC)
Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC
The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional…
- Conditions
- Bladder Cancer, Non-Muscle Invasive Bladder Cancer (NMIBC), Urothelial Carcinoma, Carcinoma in Situ (CIS)
- Trial name
- NCT07322263
- Testing
- Intravesical Gemcitabine and Docetaxel
- Where
- United States
- Volunteers
- 174 people
- Sponsor
- Michael A. O'Donnell
COVID-19, BCG Vaccination
Outcome of COVID-19 Cases Based on Tuberculin Test: Can Previous BCG Alter the Prognosis?
There is no evidence that the Bacille Calmette-Guérin vaccine (BCG) protects people against infection with COVID-19 virus. Two clinical trials addressing this question are underway, and WHO will evaluate the evidence when it is…
- Trial name
- NCT04347876
- Testing
- Tuberculin test
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Assiut University
Tuberculosis
BCG Revaccination Study in Diabetic and Non-Diabetic Adults
The purpose of this study is to: 1. explore whether investigators can make BCG more effective by giving it in a different way. For this, aerosol inhaled BCG will be compared against the conventional BCG injection. 2.
- Trial name
- NCT06246851
- Testing
- BCG Danish
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Oxford
NMIBC
The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.
The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer. The main questions it aims to answer are: 1.
- Trial name
- NCT07445308
- Testing
- SPGL008
- Volunteers
- 120 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
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
Bladder Cancer
Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients
This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease.
- Trial name
- ALBAN (NCT03799835)
- Testing
- BCG, Atezolizumab
- Where
- 38 sites in Belgium, France and 1 more
- Volunteers
- 517 people
- Sponsor
- UNICANCER
Bladder Cancer, CIS
A Prospective Registry to Assess the Effectiveness and Local Tolerability of Intravesical Valrubicin in Subjects With Non-muscle Invasive Bladder Cancer (NMIBC)
The purpose of this study is to observe and describe the effectiveness and local tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a cohort of subjects treated under routine…
- Trial name
- NCT01314664
- Where
- 11 sites in United States
- Volunteers
- 15 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company