Clinical trials: BCG
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
Phase I Clinical Protocol for Pre-evaluation of the Safety of BCG-PPD in Tuberculosis Patients
A total of 60 TB patients aged 65 years and below who are randomly assigned to the experimental group and the control group. The experimental group is injected with BCG-PPD test drug once, and the control group is injected with…
- Trial name
- NCT04538911
- Testing
- BCG-PPD
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
BCG Vaccination Reaction, Tuberculosis
A Study of GC3107(BCG Vaccine) in Healthy Infants
The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants
- Trial name
- NCT03947138
- Testing
- GC3107, Intradermal BCG SSI inj.
- Where
- 2 sites in South Korea
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Non Muscle Invasive Bladder Cancer
Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)
The purpose of this clinical trial is to obtain long-term follow-up information and status of bladder cancer for patients who received study treatment in the QUILT-2.005 study.
- Trial name
- NCT05981131
- Testing
- N803 plus Bacillus Calmette-Guerin (BCG)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- ImmunityBio, Inc.
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
Tuberculosis
Study to Evaluate the Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-exposed/-Unexposed Newborn Infants in South Africa
Goal of Serum Institute of India Limited (SIIL) is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis…
- Trial name
- NCT02391415
- Testing
- VPM1002, BCG, VPM1002(Hyg+)
- Where
- 4 sites in South Africa
- Volunteers
- 416 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Healthy
A Study of Comparing Safety and Reactogenicity, of Lyophilized BCG Vaccine IP of Green Signal Bio Pharma Private Limited, India With BCG Vaccine of Serum Institute of India Limited in 120 Healthy Children.
To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited India with BCG vaccine of serum institute of India limited (SIIL), India in 120 healthy children.
- Trial name
- NCT01250249
- Testing
- BCG Vaccine IP - Serum Institute of India
- Where
- India
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Green Signal Biopharma Private Limited
Tuberculosis (TB)
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and…
- Trial name
- MTBVACph2 (NCT06997367)
- Testing
- MTBVAC, BCG Sii
- Where
- 2 sites in India
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
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
Tuberculosis
Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in Newborn Infants in South Africa
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 tuberculosis (TB) for residents in endemic areas…
- Trial name
- NCT01479972
- Testing
- VPM1002, BCG
- Where
- South Africa
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
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.
Tuberculosis
Phase I Clinical Protocol of BCG-PPD in Healthy People
A total of 80 healthy people aged 65 years and below who are randomly assigned to the experimental group and the control group. The experimental group is injected with BCG-PPD test drug once, and the control group is injected…
- Trial name
- NCT04593771
- Testing
- BCG-PPD
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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.
Mycobacterium Tuberculosis Infection
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation)…
- Trial name
- VPM1002 (NCT04351685)
- Testing
- VPM1002, BCG SII
- Where
- 12 sites in Gabon, Kenya and 3 more
- Volunteers
- 6,940 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.