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Virus Therapy

mRNA-1273.351 for COVID-19

Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
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 day 1 pre-dose, day 15, day 29, day 43, day 57, day 71, day 85, day 147, day 237, day 422
Awards & highlights

Study Summary

Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults

Eligible Conditions
  • COVID-19
  • Coronavirus
  • COVID-19 Vaccination

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 pre-dose, day 15, day 29, day 43, day 57, day 71, day 85, day 147, day 237, day 422
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 pre-dose, day 15, day 29, day 43, day 57, day 71, day 85, day 147, day 237, day 422 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)
Frequency of Any Serious Adverse Events (SAEs)
+5 more
Secondary outcome measures
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1B
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2B
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-H
+21 more

Side effects data

From 2021 Phase 2 trial • 660 Patients • NCT04405076
15%
Myalgia
10%
Hypertension
10%
Intervertebral disc protrusion
10%
Arthralgia
5%
Arrhythmia
5%
Depression
5%
Sinusitis bacterial
5%
Nasal polyps
5%
Staphylococcal infection
5%
Labyrinthitis
5%
Herpes zoster
5%
Lymphadenopathy
5%
Headache
5%
Bursitis
5%
Fatigue
5%
Blood pressure increased
5%
Animal bite
5%
Cystitis
5%
Thyroid disorder
5%
Extrasystoles
5%
Nasal septum deviation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Part A: Placebo
Part A: 50 ug mRNA-1273
Part A: 100 ug mRNA-1273
Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273
Part C: 20 ug mRNA-1273.351
Part B: Placebo Then 100 ug mRNA-1273
Part C: 50 ug mRNA-1273.351

Trial Design

10Treatment groups
Experimental Treatment
Group I: Arm 2HExperimental Treatment2 Interventions
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Group II: Arm 2GExperimental Treatment2 Interventions
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Group III: Arm 2FExperimental Treatment2 Interventions
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29 in COVID-19 naïve participants. N=20
Group IV: Arm 2EExperimental Treatment2 Interventions
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29 in COVID-19 naïve participants. N=20
Group V: Arm 2DExperimental Treatment1 Intervention
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Group VI: Arm 2CExperimental Treatment1 Intervention
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Group VII: Arm 2BExperimental Treatment2 Interventions
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57 in COVID-19 naïve participants. N=15
Group VIII: Arm 2AExperimental Treatment2 Interventions
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57 in COVID-19 naïve participants. N=15
Group IX: Arm 1BExperimental Treatment2 Interventions
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273 in DMID Protocol 20-0003 (NCT04283461). N=30.
Group X: Arm 1AExperimental Treatment1 Intervention
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273 in DMID Protocol 20-0003 (NCT04283461). N=30.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1273
2021
Completed Phase 4
~58700
mRNA-1273.351
2020
Completed Phase 2
~2070

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,565 Total Patients Enrolled
78 Trials studying COVID-19
292,073 Patients Enrolled for COVID-19
ModernaTX, Inc.Industry Sponsor
106 Previous Clinical Trials
61,376,851 Total Patients Enrolled
36 Trials studying COVID-19
61,259,302 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.
Recent research and studies
[]Journal
Safety and Immunogenicity of a Third Dose of Sars-cov-2 Mrna Vaccine — an Interim Analysis
Anderson, Evan, Lisa Jackson, Nadine Rouphael, Alicia Widge, David Montefiori, Nicole Doria-Rose, Mehul Suthar, et al.. 2022. “Safety and Immunogenicity of a Third Dose of Sars-cov-2 Mrna Vaccine — an Interim Analysis”. []. Research Square Platform LLC. doi:10.21203/rs.3.rs-1222037/v1.
clinicaltrials.govStudy
Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults
2021. "Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04785144.
~34 spots leftby Apr 2025
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