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Virus Therapy

mRNA-1283.211 for COVID-19

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 days 1, 15, 29, 90, 181, and 366
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of two possible vaccines for COVID-19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 15, 29, 90, 181, and 366
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 15, 29, 90, 181, and 366 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29
Part A: GMT of SARS-CoV-2 Specific Binding Antibody (bAb) Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29
+10 more
Secondary outcome measures
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Days 1, 15, 29, 181, and 366
Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Days 1, 15, 29, 181, and 366
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Days 1, 15, 29, 181, and 366
+7 more

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-1283.211
2021
Completed Phase 2
~550
mRNA-1283.529
2021
Completed Phase 2
~550

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
105 Previous Clinical Trials
61,372,701 Total Patients Enrolled
35 Trials studying COVID-19
61,255,182 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.

What other research has been conducted using mRNA-1283.211?

"The original research on mRNA-1283.211 was conducted in 2020 by the Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases. So far, 8 studies have been completed with 28 more currently underway; a large portion of these are based in Phoenix, Arizona."

Answered by AI

What other similar research projects exist for comparison?

"Since 2020, mRNA-1283.211 has undergone extensive clinical trials. The first of these was sponsored by ModernaTX, Inc and took place in that same year. It involved 120 people and resulted in Phase 1 approval for the drug. Currently, there are 28 active studies being conducted in 219 cities across 22 nations."

Answered by AI

Are there any remaining slots available for participants in this research?

"According to the latest information available on clinicaltrials.gov, this particular trial is not currently looking for patients. This study was originally posted December 6th, 2021 and has had recent activity on September 22nd, 2022. Although this one isn't enrolling right now, there are 1,151 other trials that are searching for participants at this time."

Answered by AI

How does mRNA-1283.211 compare to other treatments in terms of safety?

"mRNA-1283.211 is still in Phase 2 clinical trials, so there is not yet data supporting its efficacy. However, there is some evidence that it may be safe, which gives it a score of 2."

Answered by AI

In how many different medical facilities is this research project being conducted currently?

"This trial is recruiting patients at 17 different locations, including MedPharmics, LLC in Phoenix, Rochester Clinical Research, Inc. in Rochester, and MedPharmics in Metairie."

Answered by AI

Could you please give the total number of people signing up for this clinical trial?

"No, this research project is not looking for volunteers at the moment. The trial was first advertised on December 6th 2021 and was last updated September 22nd 2022. If you are interested in other studies, please note that there are 1123 trials actively recruiting participants with covid-19 and 28 mRNA-1283.211 trials also seeking volunteers."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Texas
How old are they?
18 - 65
What site did they apply to?
MedPharmics, LLC
ACRC Trials
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
~167 spots leftby Mar 2025