Clinical trials: BCG
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
Tuberculosis
PPD Size and Mycobacteria Tuberculosis ELISPOT in Children Who Have Received BCG in Neonate Period
To investigate the size of PPD and TB specific ELISPOT among children between 3m/o and 15 y/o . Calculate the normal range of age specific PPD size in children who recieved BCG at new-born period.
- Trial name
- NCT00172783
- Where
- Taiwan
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
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
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to…
- Trial name
- NCT02378207
- Testing
- H4:IC31, H56:IC31, BCG
- Where
- South Africa
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Aeras
Immunization Coverage
Mobile Nudges to Increase Early Vaccination Coverage in Rural Areas
Despite major progress made in vaccination coverage overall, timeliness of vaccines remains a key concern in many settings. At the same time, access to mobile phones has increased rapidly, offering new opportunities to track and…
- Trial name
- GEVaP (NCT03797950)
- Testing
- Voice Reminder (Group A), Cash Incentive (Group B)
- Where
- Ghana
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Swiss Tropical & Public Health Institute
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
DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed with BCG to determine if immunization reduces the risk of TB infection
- Trial name
- DAR-PIA (NCT02712424)
- Testing
- DAR-901
- Where
- Tanzania
- Volunteers
- 625 people, healthy volunteers welcome
- Sponsor
- Dartmouth-Hitchcock Medical Center
Tuberculosis
A Study of MVA85A in Healthy Infants
This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without tuberculosis or HIV infection.
- Trial name
- NCT00953927
- Testing
- MVA85A/AERAS-485, Candida Skin Test Antigen
- Where
- 3 sites in South Africa
- Volunteers
- 2,797 people, healthy volunteers welcome
- Sponsor
- Aeras
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
Trial to Investigate the Effect of Schistosoma Mansoni Infection on the Response to Vaccination With MVA85A in BCG-vaccinated African Adolescents
Mycobacterium tuberculosis (M. tb) is a pathogen with worldwide distribution which infects humans causing tuberculosis (TB), a transmissible disease resulting in very high mortality and morbidity; development of an effective…
- Trial name
- TB036 (NCT02178748)
- Testing
- MVA85A
- Where
- Uganda
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Heterologous Immunity, Infant Morbidity
Comparing Morbidity and Mortality Effects of Two Different Strains of BCG
Background: Investigators at Bandim Health Project (BHP, www.bandim.org) in Guinea-Bissau have shown in several randomized trials that the Bacille-Calmette-Guérin (BCG) vaccine against tuberculosis (TB) is associated with reduced…
- Conditions
- Heterologous Immunity, Infant Morbidity, Infant Mortality, Trained Immunity
- Trial name
- NCT03400878
- Testing
- BCG-Japan, BCG-Russia
- Where
- 2 sites in Guinea-Bissau
- Volunteers
- 17,505 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Infant Mortality, BCG
Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial
The purpose of this study is to determine whether BCG vaccination shortly after birth can reduce early infant mortality in a rural and an urban setting.
- Trial name
- BCGR (NCT02504203)
- Testing
- BCG-Denmark 1331 (Statens Serum Institute)
- Where
- Guinea-Bissau
- Volunteers
- 2,332 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
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
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
Tuberculosis
A Study of MVA85A in Healthy Children and Infants
This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and highly immunogenic in a wide range of subjects…
- Trial name
- NCT00679159
- Testing
- MVA85A, Prevenar
- Where
- South Africa
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Vaccine Preventable Disease, Measles
Measles and BCG Vaccines for Mother and Child
In Africa, the mortality from infectious diseases remains high. The investigators have discovered that live vaccines such as the BCG vaccine against tuberculosis and the measles vaccine can strengthen resistance to other…
- Conditions
- Vaccine Preventable Disease, Measles, Mother-Infant Interaction, BCG Vaccination Reaction
- Trial name
- MATVAC (NCT04899765)
- Testing
- BCG vaccine, Measles vaccine
- Where
- Guinea-Bissau
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Infant Mortality, BCG
Can BCG Vaccination at First Health-facility Contact Reduce Early Infant Mortality?
Bacillus Calmette-Guérin (BCG) vaccination is recommended at birth to protect against tuberculosis (TB) in countries with high TB burden. BCG is supplied in multidose vials with limited durability after reconstitution.
- Trial name
- CS-BCG (NCT04658680)
- Testing
- BCG vaccination at first health facility contact
- Where
- Guinea-Bissau
- Volunteers
- 22,800 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
BCG Infection, Reaction - Vaccine
A Study of the Interaction Between BCG And MenC Immunisation: BAM
The Bacille Calmette-Guérin (BCG) vaccine is the only vaccine licenced to prevent tuberculosis (TB). The stimulus it gives to the immune system allows it to respond more effectively to a subsequent infection with TB.
- Conditions
- BCG Infection, Reaction - Vaccine, Immune Response
- Trial name
- BAM (NCT02002156)
- Testing
- BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
Comparative Study of Bacille Calmette Guerin (BCG) Delivery Via Disposable Syringe Jet Injector and Needle & Syringe
The study is designed to test the hypothesis that BCG administration via jet injector will produce a comparable immune response and that there will be no significant differences in safety or reactogenicity between BCG…
- Trial name
- NCT01742364
- Testing
- Bioject ID Pen, Needle and syringe
- Where
- South Africa
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- PATH
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