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mRNA Vaccine

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

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 180 days from vaccination at day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a preventive treatment for COVID-19. It targets people who are at risk of getting infected. The treatment works by helping the body's immune system recognize and fight the virus.

Eligible Conditions

COVID-19
Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days from vaccination at day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days from vaccination at day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days from vaccination at day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 (50 μg)

2022

Completed Phase 1

~180

CV0501 (150 μg)

2022

Completed Phase 1

~180