Phase 2: mRNA-1010 Plus mRNA-1273 for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
DM Clinical Research - CyFair, Houston, TX
COVID-19+3 More
mRNA-1073 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.

Eligible Conditions

  • COVID-19
  • Coronavirus Disease 2019 (COVID‑19)
  • Flu caused by Influenza

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for COVID-19

Study Objectives

6 Primary · 6 Secondary · Reporting Duration: Baseline (Day 1), Days 8, 29, and 181

Day 8
Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay)
Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay)
Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay
Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay
SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay)
Up to Day 181
Number of Participants with AEs Leading to Discontinuation
Number of Participants with Adverse Events of Special Interest (AESIs)
Number of Participants with Medically-Attended AEs (MAAEs)
Number of Participants with Serious Adverse Events (SAEs)
Day 29
Number of Participants with Unsolicited Adverse Events (AEs)
Day 8
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

Trial Safety

Safety Progress

1 of 3

Other trials for COVID-19

Trial Design

8 Treatment Groups

Phase 1: mRNA-1273 Plus Placebo
1 of 8
Phase 2: mRNA-1010 Plus mRNA-1273
1 of 8
Phase 2 Dose A: mRNA-1073 Plus Placebo
1 of 8
Phase 1 Dose B: mRNA-1073 Plus Placebo
1 of 8
Phase 1 Dose A: mRNA-1073 Plus Placebo
1 of 8
Phase 1: mRNA-1010 Plus Placebo
1 of 8
Phase 1 Dose C: mRNA-1073 Plus Placebo
1 of 8
Phase 1: mRNA-1010 Plus mRNA-1273
1 of 8
Experimental Treatment

1050 Total Participants · 8 Treatment Groups

Primary Treatment: Phase 2: mRNA-1010 Plus mRNA-1273 · Has Placebo Group · Phase 1 & 2

Phase 1: mRNA-1273 Plus PlaceboExperimental Group · 2 Interventions: Placebo, mRNA-1273 · Intervention Types: Biological, Biological
Phase 2: mRNA-1010 Plus mRNA-1273
Biological
Experimental Group · 1 Intervention: mRNA-1010 · Intervention Types: Biological
Phase 2 Dose A: mRNA-1073 Plus PlaceboExperimental Group · 2 Interventions: mRNA-1073, Placebo · Intervention Types: Biological, Biological
Phase 1 Dose B: mRNA-1073 Plus PlaceboExperimental Group · 2 Interventions: mRNA-1073, Placebo · Intervention Types: Biological, Biological
Phase 1 Dose A: mRNA-1073 Plus PlaceboExperimental Group · 2 Interventions: mRNA-1073, Placebo · Intervention Types: Biological, Biological
Phase 1: mRNA-1010 Plus PlaceboExperimental Group · 2 Interventions: mRNA-1010, Placebo · Intervention Types: Biological, Biological
Phase 1 Dose C: mRNA-1073 Plus PlaceboExperimental Group · 2 Interventions: mRNA-1073, Placebo · Intervention Types: Biological, Biological
Phase 1: mRNA-1010 Plus mRNA-1273
Biological
Experimental Group · 1 Intervention: mRNA-1010 · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
mRNA-1273
2021
Completed Phase 4
~340

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (day 1), days 8, 29, and 181
Closest Location: DM Clinical Research - CyFair · Houston, TX
Photo of Houston  1Photo of Houston  2Photo of Houston  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching COVID-19
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.