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Virus Therapy
A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters
Phase 2
Waitlist Available
Research Sponsored by ModernaTX, Inc.
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 up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests different COVID-19 booster vaccines on people who have already received previous doses. The goal is to see if these boosters can improve immunity against the virus and its variants. Booster doses of COVID-19 vaccines are a strategy to improve effectiveness as immunity decreases and new variants emerge.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Part B: mRNA-1283.529 Dose Level 2Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1283.529 as a second booster at Dose Level 2 on Day 1.
Group II: Part B: mRNA-1283.529 Dose Level 1Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1283.529 as a second booster at Dose Level 1 on Day 1.
Group III: Part A: mRNA-1283.211 Dose Level 2Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1283.211 at Dose Level 2 on Day 1.
Group IV: Part A: mRNA-1283.211 Dose Level 1Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1283.211 at Dose Level 1 on Day 1.
Group V: Part A: mRNA-1283 Dose Level 3Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1283 at Dose Level 3 on Day 1.
Group VI: Part A: mRNA-1283 Dose Level 2Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1283 at Dose Level 2 on Day 1.
Group VII: Part A: mRNA-1283 Dose Level 1Experimental Treatment1 Intervention
Participants will receive single intramuscular (IM) injection of mRNA-1283 at Dose Level 1 on Day 1.
Group VIII: Part A: mRNA-1273Active Control1 Intervention
Participants will receive single IM injection of mRNA-1273 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1283
2021
Completed Phase 2
~650
mRNA-1283.529
2021
Completed Phase 2
~540
mRNA-1283.211
2021
Completed Phase 2
~540
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
120 Previous Clinical Trials
61,587,669 Total Patients Enrolled
41 Trials studying COVID-19
61,383,765 Patients Enrolled for COVID-19