Clinical trials: BCG Vaccine
COVID-19
The Role of BCG Vaccine in the Clinical Evolution of COVID-19 and in the Efficacy of Anti-SARS-CoV-2 Vaccines
Clinical trial with randomized allocation in two arms (BCG vaccine versus placebo) of volunteers at risk but not yet infected nor vaccinated against SARS-CoV-2.
- Trial name
- SARS-CoV-2 (NCT05507671)
- Testing
- BCG (Bacillus Calmette-Guérin) vaccine
- Where
- 4 sites in Brazil
- Volunteers
- 556 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
Influenza Virus Infection, Trained Immunity
Effects of BCG on Influenza Induced Immune Response
In the present study, the investigators want to investigate whether prior BCG-vaccination improves the efficacy of influenza ("the flu") vaccination in young and/or old healthy volunteers and consequently could protect against…
- Trial name
- NCT02114255
- Testing
- BCG
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Safety, Immunogenicity
EMaBS TB Vaccine Study
The study will commence with a dose-escalation and age de-escalation study in healthy adults and adolescents from the previous Entebbe Mother and Baby Study (EMaBS) in Entebbe, Uganda, focusing on ChAdOx1 85A, to provide safety…
- Trial name
- NCT03681860
- Testing
- ChAdOx185A, MVA85A, BCG
- Where
- 2 sites in Uganda, United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of Oxford
BCG Vaccination
Trained Immunity in Fungal Infection and Its Mechanism
Investigator vaccinated 76 healthy BCG-naive participant with BCG, while 3 participants received. Half of BCG-vaccinated participants (n = 38) received an incremental dose of metformin for 6 days (up to 1,000 mg twice daily on…
- Trial name
- NCT06628544
- Testing
- BCG vaccination, Metformin is administered on the day 0, Metformin is administered on the day 9
- Where
- China
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Zhongnan Hospital
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
A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile females.
- Trial name
- NCT02066428
- Testing
- AERAS-404
- Where
- Sweden
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Aeras
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
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
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
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
Non-Muscle Invasive Bladder Cancer, HER2
RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression
This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing.
- Trial name
- NCT05957757
- Testing
- RC48, Tislelizumab
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- RenJi Hospital
Tuberculosis
A Clinical Challenge Study of BCG in Healthy Volunteers
TB031 is a challenge study comparing two different strains of the Bacille Calmette-Guérin (BCG) vaccine at standard and high dose.
- Trial name
- NCT02088892
- Testing
- BCG SSI, BCG Tice
- Where
- 2 sites in United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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
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
Tuberculosis Infection, Tuberculosis
BCG Revaccination in Children and Adolescents
Bacille Calmette Guerin (BCG) vaccine is one of the most used vaccines of the world, to reduce the risks of natural tuberculous infection.
- Trial name
- BRiC (NCT05330884)
- Testing
- BCG vaccine, Oral Chemoprophylaxis
- Where
- India
- Volunteers
- 9,200 people, healthy volunteers welcome
- Sponsor
- Tuberculosis Research Centre, India
Tuberculosis
Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A
This trial will investigate the administration of two new tuberculosis vaccines, called AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these vaccines are given one after the other.
- Trial name
- NCT01683773
- Testing
- AERAS-402, MVA85A
- Where
- 2 sites in United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Oxford