Clinical trials: BCG Vaccine
Bladder Cancer
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients
In this study, the investigators would like to assess how intravesical BCG schedules after immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together with adjuvant AS15 (recMAGE-A3 + AS15 ASCI)…
- Trial name
- NCT01498172
- Testing
- MAGE-A3 ASCI, BCG
- Where
- Switzerland
- Volunteers
- 23 people
- Sponsor
- Patrice Jichlinski
Bladder Cancer
Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer
A significant number of patients with high risk superficial bladder cancer has progression to invasive disease. No consensus exists regarding the optimal treatment to decrease the recurrence and progression rate.
- Trial name
- NCT00696579
- Testing
- BCG, gemcitabine
- Where
- Italy
- Volunteers
- 64 people
- Sponsor
- University Of Perugia
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
High-risk NMIBC
A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC
The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316.
- Trial name
- NCT05410730
- Testing
- SHR-1501
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
- Conditions
- Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma, Urologic Cancer, Bladder Cancer
- Trial name
- NCT06443944
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 27 sites in United States
- Sponsor
- CG Oncology, Inc.
Non-muscular Invasive Bladder Cancer
BCG for Therapeutic Use Phase I Clinical Trial
This clinical study adopted a single-arm, open, single-centertrial design. The purpose of this study was to evaluate the safety and tolerability, PK characteristics, shedding and immune response characteristics of BCG for…
- Trial name
- NCT06100653
- Testing
- BCG for therapeutic use
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Carcinoma in Situ, Bladder Cancer
Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG)
This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus Calmette-Guerin (BCG) for CIS and in whom recurrence or…
- Trial name
- Bladder Cancer (NCT01316874)
- Testing
- Valrubicin, 800 mg
- Where
- 39 sites in United States
- Volunteers
- 90 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8
Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of…
- Conditions
- Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
- Trial name
- GAIN-BCG (NCT07000084)
- Testing
- BCG Solution, Biopsy of Bladder, Cystoscopy
- Where
- 60 sites in United States
- Volunteers
- 330 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Tuberculosis
Phase 1 Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Adolescent
The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent.
- Trial name
- NCT03806699
- Testing
- ID93+GLA-SE
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
Tuberculosis
Influence of Filarial Infections on Tuberculosis Disease and Tuberculosis Vaccination in Cameroon
Filarial nematodes modulate the host immune response to promote regulatory and T helper type 2 immune responses, which were shown to influence concomitant infections.
- Trial name
- MAP-TB (NCT04547738)
- Testing
- TB treatment according to national guidelines
- Where
- Cameroon
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bonn
Non-Muscle Invasive Bladder Cancer (NMIBC)
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment
A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.
- Trial name
- NMIBC (NCT03672240)
- Testing
- APL-1202
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Asieris Pharmaceutical Technologies Co., Ltd.
HIV Infections, Neonatal Infection
Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
Maternal infections affect the basal immune status of neonates. One of the possible mechanism is the fetomaternal microchimerism, in which some cells and active substances are exchanged bi-directionally between maternal and fetal…
- Conditions
- HIV Infections, Neonatal Infection, LTBI - Latent Tuberculosis Infection, Immune Tolerance
- Trial name
- IMMUNEO (NCT03383211)
- Testing
- RNAseq
- Where
- 2 sites in Moldova
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- George Washington University
Bladder Cancer, BCG
Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients
Studies in the literature are limited both throughout Turkey and in general. For this reason, as a result of the study that we will create, it will provide us with information for bladder protective treatments in patients who do…
- Conditions
- Bladder Cancer, BCG, Gemcitabine, Docetaxel
- Trial name
- NCT06374914
- Testing
- Intravesical Solution
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Dokuz Eylul University
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
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
Innate Immunity, Bacille Calmette-Guérin
Testing if BCG (Bacille Calmette-Guérin) Vaccination Can Induce Innate Immune Training in Adult People Above 50 Years of Age in Guinea-Bissau
The propose is to test innate immune training in a pilot study of 40 adults >50 years of age people in Guinea-Bissau. The hypothesis is that BCG vaccination will be associated with increased innate immune training measured as…
- Trial name
- NCT02953327
- Testing
- Bacille Calmette-Guerin, BCG solvent
- Where
- Guinea-Bissau
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Tuberculosis
Phase 2 Study of the ТВ/Flu-05Е Tuberculosis Vaccine
The aim of the study is to investigate immunogenicity and safety of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years
- Trial name
- NCT06873282
- Testing
- TB/Flu-05E
- Where
- 3 sites in Russia
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Research Institute of Influenza, Russia
Healthy
Safety/Efficacy Trial of Killed Leishmania Vaccine in Volunteers With no Response to Leishmanin
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
- NCT00429715
- Testing
- Alum-ALM + BCG
- Where
- Iran
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Tehran University of Medical Sciences
Bladder Cancer
Toripalimab Combined With BCG Perfusion for the Treatment of HR-NMIBC After TURBT Surgery Exploration
This is a single-center, prospective, open-label, non-randomized clinical study initiated and conducted by the Department of Urology, Shanghai Changhai Hospital.
- Trial name
- MARINE-01 (NCT07307456)
- Testing
- Treatment with toripalimab combined with BCG perfusion following transurethral resection of bladder tumor (TURBT)
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Changhai Hospital
Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC.
- Conditions
- Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT04752722
- Testing
- EG-70 (phase 1), EG-70 (phase 2) Master Protocol, Surfactant Bladder Pre-Rinse and EG-70 (Substudy)
- Where
- 102 sites in United States, Australia and 8 more
- Volunteers
- 350 people
- Sponsor
- enGene, Inc.