Evaluating the Safety, Tolerability and Immunogenicity of bacTRL-Spike Vaccine for Prevention of COVID-19
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|ClinicalTrials.gov Identifier: NCT04334980|
Recruitment Status : Active, not recruiting
First Posted : April 6, 2020
Last Update Posted : March 4, 2021
|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=24. 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.
- Group 5 (n=12): DSMB-defined prime and boost doses of bacTRL-Spike delivered with a 28-day intervening interval.
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 :||24 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|
|Actual Study Start Date :||November 2, 2020|
|Estimated Primary Completion Date :||February 8, 2022|
|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
|Nucleus Network Pty Ltd (Trading as Centre for Clinical Studies)|
|Melbourne, Victoria, Australia, 3004|
|Study Director:||Eric L Sievers, MD||Chief Medical Officer|
|Principal Investigator:||Paul Griffin, FRACP FRCPA FACTM FIML AFACHSM||Principal Investigator|