Clinical trials: BCG
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
Immunity, Cellular, Hypersensitivity, Delayed Type
Immune Responses to BCG Vaccination in Malawi and the UK
BCG vaccination has been found to provide greater protection against TB in the UK than in Malawi. This study compares immune responses in BCG-vaccinated and unvaccinated teenagers and young adults in Malawi and in the UK.
- Trial name
- NCT00241657
- Testing
- BCG
- Where
- 2 sites in Malawi, United Kingdom
- Volunteers
- healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
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.
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
Covid19, Morbidity
BCG to Reduce Absenteeism Among Health Care Workers During the COVID-19 Pandemic
The COVID-19 pandemic challenges available hospital capacity. Strategies to protect health care workers (HCW) are desperately needed.
- Conditions
- Covid19, Morbidity, Absenteeism
- Trial name
- EDCTP (NCT04641858)
- Testing
- BCG-Denmark, Saline
- Where
- 2 sites in Guinea-Bissau, Mozambique
- Volunteers
- 668 people, healthy volunteers welcome
- Sponsor
- University of Southern Denmark
Tuberculosis
ID93/GLA-SE Vaccination + BCG Challenge
The purpose of this study is to: 1. Demonstrate the safety of a novel TB vaccine (ID93/GLA-SE) when given to both BCG-vaccinated and BCG-naïve volunteers. 2.
- Trial name
- NCT06670755
- Testing
- ID93/GLA-SE, BCG Danish
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
The purpose of this study is to demonstrate the efficacy of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus…
- Trial name
- NCT04152161
- Testing
- BCG vaccine SSI
- Where
- 5 sites in South Africa
- Volunteers
- 1,836 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
HIV Exposure, HIV Infection
Early Versus Delayed BCG Vaccination of HIV-exposed Infants
In sub-Saharan Africa (SSA), more than 300,000 babies with HIV die each year. HIV-infected children develop AIDS and die faster in SSA than those in developed countries.
- Trial name
- NCT02062580
- Testing
- BCG
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- University of Cape Town
Tuberculosis
Phase 2a Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Healthcare Workers
The purpose of this study is to evaluate the experimental tuberculosis (TB) vaccine called ID93+GLA-SE. The safety, immunogenicity, and efficacy of ID93+GLA-SE will be compared to placebo, after three intramuscular (IM)…
- Trial name
- NCT03806686
- Testing
- ID93+GLA-SE
- Where
- 3 sites in South Korea
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
Vitamin A Deficiency
Efficacy of Newborn Vitamin A Supplementation in Improving Immune Function
Vitamin A supplementation at birth may increase survival of infants through one year of age by reducing mortality from infectious diseases, though current studies are not conclusive on this point.
- Trial name
- NCT01583972
- Testing
- retinyl palmitate
- Where
- Bangladesh
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- USDA, Western Human Nutrition Research Center
Tuberculosis
Safety of Tuberculosis Vaccine, MVA85A, Administered by the Aerosol Route and the Intradermal Route
This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intradermal route in healthy BCG-vaccinated adult subjects.
- Trial name
- NCT01497769
- Testing
- Aerosol inhaled MVA85A, Intradermal MVA85A
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis, Healthy
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation in inducing protection against tuberculosis…
- Trial name
- MTBVAC (NCT02013245)
- Testing
- MTBVAC live vaccine, Commercially available BCG live vaccine
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
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
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
Tuberculosis
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
The purpose of the study is to develop a BCG challenge model for use in short term Phase I human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune responses to impact in vivo mycobacterial…
- Trial name
- NCT05592223
- Testing
- BCG Vaccine USP, Isoniazid, Rifampin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer 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
TB
A Study of the Immunogenicity of BCG, Delivered Intradermally in Healthy Volunteers
To assess the immunogenicity of M. bovis BCG (SSI strain), given intrademally in the standard dose used in clinical practice and to measure the development of the immune response in the first six months after administration. M.
- Trial name
- NCT00480714
- Testing
- BCG (SSI Strain)
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Death; Neonatal, Death, Infant
Trial to Compare BCG-Bulgaria and BCG-Denmark
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 vaccination with Bacillus Calmette-Guérin (BCG) Danish strain (AJ Vaccines…
- Conditions
- Death; Neonatal, Death, Infant, Morbidity;Newborn, Morbidity;Infant
- Trial name
- BCGSTRAIN IV (NCT05397678)
- Testing
- BCG-Denmark, BCG-Bulgaria
- Where
- Guinea-Bissau
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Tuberculosis
A Leukapheresis Study for Immune Responses in Healthy US Adults Who Receive BCG Vaccination Followed by Boosting With AERAS-402
Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on Study Days 0 and 28.
- Trial name
- C-021-402 (NCT02375256)
- Testing
- AERAS-402, BCG (1-8 x105 cfu ID)
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Aeras
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