Evaluating the Safety, Tolerability and Immunogenicity of bacTRL-Spike Vaccine for Prevention of COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04334980|
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : September 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: bacTRL-Spike||Phase 1|
Protocol bacTRL-Spike-1 will be the first-in-human study of bacTRL-Spike, and the first-in-human use of orally delivered bacTRL. The trial is designed to evaluate the safety and tolerability of orally delivered bacTRL-Spike vaccine in healthy adults.
Total anticipated enrollment is n=12. The distribution of the sample size will be as follows:
- Group 1 (n=3; Sentinel +2): Single dose of bacTRL-Spike, equivalent to 1 billion colony forming units (cfu) of Bifidobacterium longum (B. longum);
- Group 2 (n=3; Sentinel +2): Single dose of bacTRL-Spike, equivalent to 3 billion cfu of B. longum;
- Group 3 (n=3; Sentinel +2): Single dose of bacTRL-Spike, equivalent to 10 billion cfu of B. longum;
- Group 4 (n=3): Single Data and Safety Monitoring Board (DSMB)-defined dose of bacTRL-Spike among subjects 56 years of age and older.
The planned trial duration is 18 months.
Each participant will remain in the trial for 12-13 months, including a screening phase of up to 28 days, intervention phase of 1 day and follow-up phase of 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Immunogenicity of the bacTRL-Spike Oral Candidate Vaccine for the Prevention of COVID-19 in Healthy Adults|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||February 28, 2022|
Each oral dose of bacTRL-Spike contains bacterial medium with either 1 billion (Group 1), 3 billion (Group 2) or 10 billion (Group 3) colony-forming-units of live Bifidobacterium longum, which has been engineered to deliver plasmids containing synthetic DNA encoding spike protein from SARS-CoV-2.
- Frequency of Adverse Events [ Time Frame: Up to12 months post-vaccination ]Adverse events (specifically including incidence of gastrointestinal-associated events) following administration of oral bacTRL-Spike
- Immune response against SARS-CoV-2 Spike protein [ Time Frame: Baseline (pre-vaccination), and 1, 3 and 12 months post-vaccination ]Antibody against SARS-CoV-2 Spike protein
- Incidence of COVID-19 infection [ Time Frame: Up to 12 months post-vaccination ]Incidence and clinical phenotype of confirmed and probable COVID-19 infection among vaccinated participants, based on current public health definitions
- bacTRL-Spike in stool post-vaccination [ Time Frame: Days 8, 15, 22, and 1 and 3 months post-vaccination ]Isolation of viable bacTRL-Spike from stool post-vaccination
- Immunity against SARS-CoV-2 [ Time Frame: Up to 12 months post-vaccination ]Collection of biological samples for future studies to understand immunity against SARS-CoV-2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334980
|Contact: Alexander Graves, PhD, MBA||(604) email@example.com|
|Contact: Michelle Jones, RN, M.Sc., MBAfirstname.lastname@example.org|
|Nucleus Network Pty Ltd (Trading as Centre for Clinical Studies)|
|Melbourne, Victoria, Australia, 3004|
|Contact: Paul Griffin, MD email@example.com|
|Principal Investigator: Paul Griffin, MD|
|Study Director:||Eric L Sievers, MD||Chief Medical Officer|
|Principal Investigator:||Paul Griffin, FRACP FRCPA FACTM FIML AFACHSM||Principal Investigator|