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mRNA Vaccine

CV0501 (6 μg) for COVID-19

Q: Are medical professionals currently enrolling participants for this trial?

Confirming the information available on clinicaltrials.gov, this medical experiment is actively recruiting participants and was posted on August 12th 2022 with a recent update occurring November 22nd 2022.

Q: How many medical establishments are currently hosting this clinical research?

This trial is occurring at Meridian Clinical Research (Savannah <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>) in Savannah, GA, Sundance Clinical Research in Saint Louis, MO, and Research Centers of America - CenExcel in Hollywood, FL with additional sites scattered across the United States.

Q: Has the 6 μg dosage of CV0501 been approved by the FDA?

A score of 1 has been assigned to the safety of CV0501 (6 μg) due to it being in the preliminary Phase 1 trial stage. There is only limited clinical evidence that confirms its efficacy and safety profile.

Q: What is the scale of enrollment for this investigation?

This medical trial necessitates 180 qualified candidates. Participants can join at Meridian Clinical Research in Savannah, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a> or Sundance Clinical Research in Saint Louis, <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a>.

Phase 1

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 8, 15, 29, 91, and 181

Awards & highlights

Study Summary

This trial is testing an investigational vaccine to see if it can prevent COVID-19, caused by the SARS-CoV-2 virus.

Eligible Conditions

COVID-19
Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 8, 15, 29, 91, and 181

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 8, 15, 29, 91, and 181

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 8, 15, 29, 91, and 181 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants with adverse events of special interest (AESIs) from study vaccination through the end of the study

Percentage of participants with each abnormal clinical safety laboratory finding for 8 days after study vaccination

Percentage of participants with medically attended adverse events (MAAEs) from study vaccination through the end of the study

+4 more

Secondary outcome measures

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

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part B: CV0501 Dose Cohort 7 (6 μg)Experimental Treatment1 Intervention

Part B, designed to comprise 2 single age group cohorts, Group 7a (≥18 to <65 years old) will start based on the first interim analysis of safety and immunogenicity data, provided that the SRT assesses the 12 μg dose to be immunogenic and safe.

Group II: Part B: CV0501 Dose Cohort 6 (3 μg)Experimental Treatment1 Intervention

Part B, designed to comprise 2 single age group cohorts, Group 6a (≥18 to <65 years old) will start based on the first interim analysis of safety and immunogenicity data, provided that the SRT assesses the 12 μg dose to be immunogenic and safe.

Group III: Part A: CV0501 Dose Cohort 5 (100 μg, 150 μg or 200 μg)Experimental Treatment3 Interventions

For each of the groups in Cohort 5, Group 5a (younger) and Group 5b (older age), the SRT may recommend a dose specified by the dosing scenarios in the protocol, based on their review of all available safety data. The SRT will use the same approach, independently, to select the dose levels for older participants (Group 5b) and younger participants (Group 5a).

Group IV: Part A: CV0501 Dose Cohort 4 (75 μg or 100 μg)Experimental Treatment2 Interventions

For each of the groups in Cohort 4, Group 4a (younger) and Group 4b (older age),the SRT may recommend a dose specified by the dosing scenarios in the protocol, based on their review of all available safety data. The SRT will use the same approach, independently, to select the dose levels for older participants (Group 4b) and younger participants (Group 4a).

Group V: Part A: CV0501 Dose Cohort 3 (50 μg)Experimental Treatment1 Intervention

For both Group 3a (younger) and Group 3b (older age), initiation of enrollment in the subsequent group at the next dose level for Cohorts 2-5 will depend on SRT review of safety data up to Day 8 from a minimum of 10 participants, from the previous dose level in the same age group.

Group VI: Part A: CV0501 Dose Cohort 2 (25 μg)Experimental Treatment1 Intervention

For both Group 2a (younger) and Group 2b (older age), initiation of enrollment in the subsequent group at the next dose level for Cohorts 2-5 will depend on SRT review of safety data up to Day 8 from a minimum of 10 participants, from the previous dose level in the same age group.

Group VII: Part A: CV0501 Dose Cohort 1 (12 μg)Experimental Treatment1 Intervention

Enrollment will be staggered, beginning with Group 1a (12 μg, younger adults). Initiation of enrollment in Group 1b (12 μg, older adults) will depend on Safety Review Team (SRT) review of safety data up to Day 8 from a minimum of 10 participants in Group 1a.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CV0501 (3 μg)

2022

Completed Phase 1

~180

CV0501 (6 μg)

2022

Completed Phase 1

~180

CV0501 (12 μg)

2022

Completed Phase 1

~180

CV0501 (25 μg)

2022

Completed Phase 1

~180

CV0501 (50 μg)

2022

Completed Phase 1

~180

CV0501 (75 μg)

2022

Completed Phase 1

~180

CV0501 (100 μg)

2022

Completed Phase 1

~180

CV0501 (150 μg)

2022

Completed Phase 1

~180

CV0501 (200 μg)

2022

Completed Phase 1

~180

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,748 Previous Clinical Trials

8,067,187 Total Patients Enrolled

22 Trials studying COVID-19

24,589 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are medical professionals currently enrolling participants for this trial?

"Confirming the information available on clinicaltrials.gov, this medical experiment is actively recruiting participants and was posted on August 12th 2022 with a recent update occurring November 22nd 2022."

Answered by AI

How many medical establishments are currently hosting this clinical research?

"This trial is occurring at Meridian Clinical Research (Savannah Georgia) in Savannah, GA, Sundance Clinical Research in Saint Louis, MO, and Research Centers of America - CenExcel in Hollywood, FL with additional sites scattered across the United States."

Answered by AI

Has the 6 μg dosage of CV0501 been approved by the FDA?

"A score of 1 has been assigned to the safety of CV0501 (6 μg) due to it being in the preliminary Phase 1 trial stage. There is only limited clinical evidence that confirms its efficacy and safety profile."

Answered by AI

What is the scale of enrollment for this investigation?

"This medical trial necessitates 180 qualified candidates. Participants can join at Meridian Clinical Research in Savannah, Georgia or Sundance Clinical Research in Saint Louis, Missouri."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old

2022. "Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05477186.