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

NCT04334980 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-10-25

No results posted yet for this study

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

Interventions

BIOLOGICAL

bacTRL-Spike

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.

Sponsors & Collaborators

  • Symvivo Corporation

    lead INDUSTRY

Principal Investigators

  • Eric L Sievers, MD · Chief Medical Officer

  • Paul Griffin, FRACP FRCPA FACTM FIML AFACHSM · Principal Investigator

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04334980 on ClinicalTrials.gov