PRIME-2-CoV_Beta for Coronavirus Disease 2019 (COVID‑19)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cedar Crosse Research Center, Chicago, IL
Coronavirus Disease 2019 (COVID‑19)+3 More
PRIME-2-CoV_Beta - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

PRIME-2-CoV_Beta is the first clinical candidate based on the attenuated 2nd generation Orf virus (ORFV) vaccine platform which encodes for the structural spike (S)- and nucleocapsid (N) protein of SARS-CoV-2. The aim of the multivalent vaccine is to broaden the specific immune response against SARS-CoV-2 and to increase the probability of cross-protection against emerging variants.

Eligible Conditions

  • Coronavirus Disease 2019 (COVID‑19)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Coronavirus Disease 2019 (COVID‑19)

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Up to 12 months

Day 57
Number of participants who experience at least one unsolicited Treatment-emergent Adverse Event (TEAE)
Up to 12 months
Recommended Phase 2 Dose (RP2D) of PRIME-2-CoV_Beta
Up to 6 months
Geometric Mean Concentration (GMC) of SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Geometric Mean-fold Rise (GMFR) of SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains from baseline to each subsequent timepoint
Geometric Mean-fold Rise (GMFR) of SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Geometric mean of SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains at each time point
Number of participants who achieve ≥ 4-fold rise from baseline in SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains from baseline to each subsequent timepoint
Number of participants who achieve ≥ 4-fold rise in SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Safety and tolerability assessed as incidence of changes from baseline in clinical laboratory values, vital Signs, and Electrocardiograms (ECGs)
Up to Day 15
Number of participants with solicited local reactions at the injection site
Number of participants with solicited systemic reactions

Trial Safety

Safety Progress

1 of 3

Other trials for Coronavirus Disease 2019 (COVID‑19)

Trial Design

3 Treatment Groups

Cohort A: Pre-vaccinated
1 of 3
Cohort A: SARS-CoV-2 Vaccine-naïve
1 of 3
Cohort B: 2 Pre-vaccinated elderly
1 of 3
Experimental Treatment

144 Total Participants · 3 Treatment Groups

Primary Treatment: PRIME-2-CoV_Beta · No Placebo Group · Phase 1

Cohort A: Pre-vaccinated
Drug
Experimental Group · 1 Intervention: PRIME-2-CoV_Beta · Intervention Types: Drug
Cohort A: SARS-CoV-2 Vaccine-naïve
Drug
Experimental Group · 1 Intervention: PRIME-2-CoV_Beta · Intervention Types: Drug
Cohort B: 2 Pre-vaccinated elderly
Drug
Experimental Group · 1 Intervention: PRIME-2-CoV_Beta · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
Closest Location: Cedar Crosse Research Center · Chicago, IL
Photo of Chicago 1Photo of Chicago 2Photo of Chicago 3
2008First Recorded Clinical Trial
1 TrialsResearching Coronavirus Disease 2019 (COVID‑19)
26 CompletedClinical Trials

Who is running the clinical trial?

Speransa TherapeuticsLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible for inclusion in the study if you are healthy.
You are able to give personal signed informed consent and willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
You must not have received any SARS-CoV-2 vaccine, starting after Visit 0 and continuously until 6 months after receiving the first study immunization.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.