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mRNA Vaccine

CV0501 (6 μg) for COVID-19

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

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 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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,772 Previous Clinical Trials
8,106,723 Total Patients Enrolled
23 Trials studying COVID-19
25,439 Patients Enrolled for COVID-19
~62 spots leftby Jul 2025