COVID-19Phase 1NCT04334980
Evaluating the Safety, Tolerability and Immunogenicity of bacTRL-Spike Vaccine for Prevention of COVID-19
A Phase 1 study testing bacTRL-Spike in people with COVID-19, run by Symvivo Corporation at 1 site in Australia.
Trial summary
Protocol bacTRL-Spike-1 will be the first-in-human study of bacTRL-Spike, and the first-in-human use of orally delivered bacTRL. Each oral dose of bacTRL-Spike contains bacterial medium with either 1 billion (Group 1A), 3 billion (Group 2A) or 10 billion (Group 3A) colony-forming-units of live Bifidobacterium longum… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- bacTRL-Spike
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Nov 2020to 31 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years inclusive at time of enrollment and older;
- Capable to and does provide written informed consent;
- Able to understand and agrees to comply with planned study procedures and be available for all study visits;
- Body Mass Index 18-32 kg/square meter, inclusive, at screening;
- Male or non-pregnant, non-breastfeeding females who agree to comply with applicable contraceptive requirements of the protocol (see Table 1: Acceptable Contraceptive Methods.) Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to initiation of vaccination;
- Pulse no greater than 100 beats per minute;
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- Systolic blood pressure (BP) is 85 to 150 mmHg, inclusive;
- Clinical screening laboratory evaluations:
- Absolute neutrophil count (ANC) ≥1500 cells/mm3
- Hemoglobin ≥12.0 g/dL for men and ≥11.0 g/dL for women
- Platelet count ≥120,000/mm3
- Creatinine clearance (CrCl) >80 mL/min ); Refer to the calculator located on the Frontier Science and Technology Research Foundation (FSTRF) website (at https://www.frontierscience.org/): Calculated Creatinine Clearance - Cockcroft-Gault Equation (Adult).
- Aspartate aminotransferase (AST) <1.25 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) <1.25 x ULN
- Alkaline phosphatase <2.0 x ULN
- Total bilirubin <1.1 x ULN
- Lipase <1.1 x ULN
- Prothrombin time (PT) <1.1 x ULN
- Partial thromboplastin time (PTT) <1.1 x ULN
- CRP < 2.0 x ULN
- Agree to have samples stored for secondary research related to coronaviruses.
Who cannot join
- Positive pregnancy test either at screening or just prior to vaccine administration.
- Female participant who is breastfeeding or plans to breastfeed from the time of the study vaccination through 3 months after the study vaccination.
- Has acute or chronic inflammatory condition of the gastrointestinal tract including, but not limited to, Crohn's disease, ulcerative colitis, gastritis, proctitis, or any other inflammatory bowel disorder.
- Has any medical disease, history, or behavior that may predispose to more severe COVID-19 infection, including hypertension, diabetes, current vaping and/or smoking, history of chronic smoking within the prior year (average of at least one cigarette per day or more), or body mass index of greater than 32; stable hypertension controlled with a stable dose of medication is permitted.
- Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation (including but not limited to acute, subacute, intermittent or chronic medical disease or condition that would place the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the participant's successful completion of this trial.)
- Presence of self-reported or medically documented significant medical or psychiatric condition(s).
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- Significant medical or psychiatric conditions include but are not limited to:
- Respiratory disease (e.g., chronic obstructive pulmonary disease, asthma) requiring daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years.
- Excluded asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics.
- Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.
- Neurological or neurodevelopmental conditions (e.g., migraines, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
- An autoimmune disease, including hypothyroidism without a defined non-autoimmune cause, localized or history of psoriasis.
- An immunodeficiency of any cause or are immune-suppressed.
- Has an acute illness, as determined by the site PI or appropriate sub-investigator, with or without fever (oral temperature >38.0 degrees Celsius [100.4 degrees Fahrenheit]) within 72 hours prior to study vaccination administration.
- Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
- Has participated in another investigational study involving any investigational product (study drug, biologic or device) within 60 days, or 5 half-lives, whichever is longer, before study vaccine administration.
- Currently enrolled in or plans to participate in another clinical trial with an investigational agent (including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) that will be received during the trial period.
- Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
- Chronic use (more than 14 continuous days) or anticipated use within the next 6 months of any medications that may be associated with impaired immune responsiveness. Including, but not limited to the following excluded drugs: systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period prior to vaccine administration (Day 1). The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.
- Received immunoglobulins and/or any blood or blood products within the 4 months before study vaccine administration or at any time during the study.
- Has any blood dyscrasias or significant disorder of coagulation.
- Has any chronic liver disease, including fatty liver.
- Has a history of alcohol or drug abuse or tests positive for drugs of abuse at screening.
- Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination.
- Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination.
- Receipt of any other SARS-CoV-2/COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study.
- Known current or previous laboratory-confirmed SARS CoV-1 OR SARS-CoV-2/COVID-19 infection as documented by a positive PCR test from a nasal swab.
- Known close contact of anyone with laboratory-confirmed SARS-CoV-2/COVID-19 infection within 2 weeks prior to vaccine administration.
- Has traveled outside Australia for any duration within 30 days before study vaccination.
- Currently working in occupation with high risk of exposure to SARS-CoV-2 (e.g., health care worker, emergency response personnel).
- Allergy to BOTH amoxicillin (or any penicillin derivative) AND erythromycin
- Household contact, including neonates up to the age of 28 days, with any medical condition or taking medications that may result in immunosuppression.
- The participant must agree to refrain from donating blood or plasma during the study.
- Excluded medications (summarized): Excluded asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics; Excluded immunosuppressive drugs: systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period prior to vaccine administration (Day 1); Excluded other medications - current use of any antibiotics, probiotic supplements, H2 blockers or proton pump inhibitors within 7 days prior to vaccination and any anticipated use for 7 days post vaccination.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Nucleus Network Pty Ltd Brisbane (QPharm)
Brisbane, Queensland, 3004
About this study
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
Protocol bacTRL-Spike-1 will be the first-in-human study of bacTRL-Spike, and the first-in-human use of orally delivered bacTRL. Each oral dose of bacTRL-Spike contains bacterial medium with either 1 billion (Group 1A), 3 billion (Group 2A) or 10 billion (Group 3A) colony-forming-units of live Bifidobacterium longum, which has been engineered to deliver plasmids containing synthetic DNA encoding spike protein from SARS-CoV-2.
Read the detailed description
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.
- Conditions
- COVID-19
- Being tested
- bacTRL-Spike
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bacTRL-SpikeBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| bacTRL-Spike | Experimental | * 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. Receives: Biological: bacTRL-Spike |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Adverse events (specifically including incidence of gastrointestinal-associated events) following administration of oral bacTRL-Spike
Measured: Up to12 months post-vaccination
Secondary outcomes (4)
Immune response against SARS-CoV-2 Spike protein
Antibody against SARS-CoV-2 Spike protein
Measured: Baseline (pre-vaccination), and 1, 3 and 12 months post-vaccination
Incidence of COVID-19 infection
Incidence and clinical phenotype of confirmed and probable COVID-19 infection among vaccinated participants, based on current public health definitions
Measured: Up to 12 months post-vaccination
bacTRL-Spike in stool post-vaccination
Isolation of viable bacTRL-Spike from stool post-vaccination
Measured: Days 8, 15, 22, and 1 and 3 months post-vaccination
Immunity against SARS-CoV-2
Collection of biological samples for future studies to understand immunity against SARS-CoV-2.
Measured: Up to 12 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start2 Nov 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symvivo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric L Sievers, MD, Study director, Chief Medical OfficerPaul Griffin, FRACP FRCPA FACTM FIML AFACHSM, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334980
- Sponsor's protocol ID
- bacTRL-Spike-1
- Status last verified
- May 2022
- First submitted
- 31 Mar 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04334980
- Acronym / sponsor ID
- bacTRL-Spike-1
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Symvivo CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protocol bacTRL-Spike-1 will be the first-in-human study of bacTRL-Spike, and the first-in-human use of orally delivered bacTRL. Each oral dose of bacTRL-Spike contains bacterial medium with either 1 billion (Group 1A), 3 billion (Group 2A) or 10 billion (Group 3A) colony-forming-units of live Bifidobacterium longum, which has been engineered to deliver plasmids containing synthetic DNA encoding spike protein from SARS-CoV-2.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bacTRL-Spike | Experimental | Biological: bacTRL-Spike* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age 18 years inclusive at time of enrollment and older;
- Capable to and does provide written informed consent;
- Able to understand and agrees to comply with planned study procedures and be available for all study visits;
- Body Mass Index 18-32 kg/square meter, inclusive, at screening;
- Male or non-pregnant, non-breastfeeding females who agree to comply with applicable contraceptive requirements of the protocol (see Table 1: Acceptable Contraceptive Methods.) Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to initiation of vaccination;
Key exclusion criteria (34 listed)
- Positive pregnancy test either at screening or just prior to vaccine administration.
- Female participant who is breastfeeding or plans to breastfeed from the time of the study vaccination through 3 months after the study vaccination.
- Has acute or chronic inflammatory condition of the gastrointestinal tract including, but not limited to, Crohn's disease, ulcerative colitis, gastritis, proctitis, or any other inflammatory bowel disorder.
- Has any medical disease, history, or behavior that may predispose to more severe COVID-19 infection, including hypertension, diabetes, current vaping and/or smoking, history of chronic smoking within the prior year (average of at least one cigarette per day or more), or body mass index of greater than 32; stable hypertension controlled with a stable dose of medication is permitted.
- Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation (including but not limited to acute, subacute, intermittent or chronic medical disease or condition that would place the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the participant's successful completion of this trial.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bacTRL-SpikeEach 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. | Biological | bacTRL-Spike |
Primary outcome
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
4 secondary outcomes
Immune response against SARS-CoV-2 Spike protein
Time frame: Baseline (pre-vaccination), and 1, 3 and 12 months post-vaccination
Incidence of COVID-19 infection
Time frame: Up to 12 months post-vaccination
bacTRL-Spike in stool post-vaccination
Time frame: Days 8, 15, 22, and 1 and 3 months post-vaccination
Immunity against SARS-CoV-2
Time frame: Up to 12 months post-vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric L Sievers, MD study director
Chief Medical Officer
Paul Griffin, FRACP FRCPA FACTM FIML AFACHSM principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bacTRL-Spike in people with COVID-19, run by Symvivo Corporation at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (time frame: Up to12 months post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.