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bacTRL-SpikeWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug727 Saline containing 1% Human serum albumin（solution of MSC） Wiki 1.00
drug486 MSCs Wiki 0.71
drug616 Placebo Wiki 0.10

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D014777 Virus Diseases NIH 0.11
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 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. Placebo will consist of bacterial medium without bacteria.

NCT04334980 COVID-19 Biological: bacTRL-Spike Other: Placebo

Primary Outcomes

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

Measure: Frequency of Adverse Events

Time: Up to12 months post-vaccination

Secondary Outcomes

Description: Antibody against SARS-CoV-2 Spike protein

Measure: SARS-CoV-2 antibodies

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

Description: Incidence and clinical phenotype of confirmed and probable COVID-19 infection among vaccinated participants, based on current public health definitions

Measure: Incidence of COVID-19 infection

Time: Up to 12 months post-vaccination

Description: Isolation of viable bacTRL-Spike from stool post-vaccination

Measure: bacTRL-Spike in stool post-vaccination

Time: Days 7, 14, 21, and 1 and 3 months post-vaccination

Description: Collection of biological samples for future studies to understand immunity against SARS-CoV-2.

Measure: Seroconversion of circulating anti-Spike IgG antibodies & stability of serum IgG titers

Time: Up to 12 months post-vaccination

Description: Collection of biological samples for future studies to understand immunity against SARS-CoV-2.

Measure: Effectiveness of intestinal colonization of the probiotic-based bacTRL-Spike oral vaccine

Time: Up to 12 months post-vaccination

No related HPO nodes (Using clinical trials)