Part A: CV0501 Dose Cohort 2 (25 μg) for Coronavirus Disease 2019 (COVID‑19)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Meridian Clinical Research (Savannah Georgia), Savannah, GA
Coronavirus Disease 2019 (COVID‑19)+1 More
CV0501 (50 μg) - Biological
Eligibility
18+
All Sexes
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Study Summary

Prevention of COVID-19 caused by SARS-CoV-2.

Eligible Conditions

  • Coronavirus Disease 2019 (COVID‑19)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Coronavirus Disease 2019 (COVID‑19)

Study Objectives

7 Primary · 3 Secondary · Reporting Duration: Days 1, 8, 15, 29, 91, and 181

Day 180
Percentage of participants with adverse events of special interest (AESIs) from study vaccination through the end of the study
Percentage of participants with medically attended adverse events (MAAEs) from study vaccination through the end of the study
Percentage of participants with serious adverse events (SAEs) from study vaccination through the end of the study
Day 28
Percentage of participants with unsolicited AEs for 28 days after study vaccination
Day 8
Percentage of participants with each abnormal clinical safety laboratory finding for 8 days after study vaccination
At day 29
Seroresponse rate 28 days after the booster dose, based on neutralizing Ab titers against pseudoviruses bearing S protein from SARS-CoV-2 WT, Omicron, and Delta variants at each collection timepoint
Days 1 through 7
Percentage of participants with solicited local adverse events (AE) during 7 days after vaccination
Percentage of participants with solicited systemic AE during 7 days after vaccination
Day 1
Geometric Mean Increase (GMI) from baseline of neutralizing Ab titers against pseudovirus bearing S protein from SARS-CoV-2 WT, Omicron, and Delta variants at each collection time point
Geometric Mean Titers (GMTs) of neutralizing Ab against pseudovirus bearing S protein from SARS-CoV-2 WT, Omicron, and Delta variants at each collection timepoint

Trial Safety

Safety Progress

1 of 3

Other trials for Coronavirus Disease 2019 (COVID‑19)

Trial Design

7 Treatment Groups

Part A: CV0501 Dose Cohort 2 (25 μg)
1 of 7
Part A: CV0501 Dose Cohort 3 (50 μg)
1 of 7
Part B: CV0501 Dose Cohort 6 (3 μg)
1 of 7
Part A: CV0501 Dose Cohort 4 (75 μg or 100 μg)
1 of 7
Part B: CV0501 Dose Cohort 7 (6 μg)
1 of 7
Part A: CV0501 Dose Cohort 5 (100 μg, 150 μg or 200 μg)
1 of 7
Part A: CV0501 Dose Cohort 1 (12 μg)
1 of 7
Experimental Treatment

180 Total Participants · 7 Treatment Groups

Primary Treatment: Part A: CV0501 Dose Cohort 2 (25 μg) · No Placebo Group · Phase 1

Part A: CV0501 Dose Cohort 2 (25 μg)
Biological
Experimental Group · 1 Intervention: CV0501 (25 μg) · Intervention Types: Biological
Part A: CV0501 Dose Cohort 3 (50 μg)
Biological
Experimental Group · 1 Intervention: CV0501 (50 μg) · Intervention Types: Biological
Part B: CV0501 Dose Cohort 6 (3 μg)
Biological
Experimental Group · 1 Intervention: CV0501 (6 μg) · Intervention Types: Biological
Part A: CV0501 Dose Cohort 4 (75 μg or 100 μg)Experimental Group · 2 Interventions: CV0501 (75 μg), CV0501 (100 μg) · Intervention Types: Biological, Biological
Part B: CV0501 Dose Cohort 7 (6 μg)
Biological
Experimental Group · 1 Intervention: CV0501 (3 μg) · Intervention Types: Biological
Part A: CV0501 Dose Cohort 5 (100 μg, 150 μg or 200 μg)Experimental Group · 3 Interventions: CV0501 (150 μg), CV0501 (100 μg), CV0501 (200 μg) · Intervention Types: Biological, Biological, Biological
Part A: CV0501 Dose Cohort 1 (12 μg)
Biological
Experimental Group · 1 Intervention: CV0501 (12 μg) · Intervention Types: Biological

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: days 1, 8, 15, 29, 91, and 181
Closest Location: Meridian Clinical Research (Savannah Georgia) · Savannah, GA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Coronavirus Disease 2019 (COVID‑19)
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are capable of understanding and agrees to comply with study procedures and to be available for all study visits.
You have received at least 2 doses of Comirnaty or Moderna COVID-19 Vaccine (Spikevax®), with the last dose of vaccine received at least 6 months prior to screening.
You agree to refrain from blood or plasma donation from the first study vaccination through end of study.

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.