Evaluating the Safety, Tolerability and Immunogenicity of bacTRL-Spike Vaccine for Prevention of COVID-19

NCT04334980 | Completed Phase 1 DMC

• 1 other identifier: bacTRL-Spike-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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, which has been engineered to deliver plasmids containing synthetic DNA encoding spike protein from SARS-CoV-2.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Events

  Adverse events (specifically including incidence of gastrointestinal-associated events) following administration of oral bacTRL-Spike

  Up to12 months post-vaccination

Secondary Outcomes (4)

• Immune response against SARS-CoV-2 Spike protein

  Baseline (pre-vaccination), and 1, 3 and 12 months post-vaccination

• Incidence of COVID-19 infection

  Up to 12 months post-vaccination

• bacTRL-Spike in stool post-vaccination

  Days 8, 15, 22, and 1 and 3 months post-vaccination

• Immunity against SARS-CoV-2

  Up to 12 months post-vaccination

Study Arms (1)

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.

Biological: bacTRL-Spike

Interventions

bacTRL-Spike BIOLOGICAL

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.

bacTRL-Spike

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Symvivo Corporation: lead

Study Sites (1)

Nucleus Network Pty Ltd Brisbane (QPharm)

Brisbane, Queensland, 3004, Australia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eric L Sievers, MD

  Chief Medical Officer

  STUDY DIRECTOR

• Paul Griffin, FRACP FRCPA FACTM FIML AFACHSM

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 6, 2020
• Study Start: November 2, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-05

Locations

AU (1)