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Virus Therapy

mRNA-1273 for COVID-19

Phase 1
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 29, day 36, day 57, day 209, and day 394
Awards & highlights

Study Summary

This trial is testing how safe and effective different doses of two vaccines are in healthy adults.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 29, day 36, day 57, day 209, and day 394
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 29, day 36, day 57, day 209, and day 394 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Medically-Attended AEs (MAAEs), AE of Special Interest (AESIs), and Serious Adverse Events (SAEs)
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Secondary outcome measures
GM of SARS-CoV-2-Specific Binding Antibody (bAb)
Geometric Mean (GM) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
Seroconversion as Measured by an Increase of SARS-CoV-2-Specific nAb Titer or bAb Titer

Trial Design

5Treatment groups
Experimental Treatment
Group I: mRNA-1283 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 2 IM injections of mRNA-1283 at Dose Level 3 on Day 1 and Day 29.
Group II: mRNA-1283 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 2 IM injections of mRNA-1283 at Dose Level 2 on Day 1 and Day 29.
Group III: mRNA-1283 Dose Level 1Experimental Treatment1 Intervention
Participants will receive 2 intramuscular (IM) injections of mRNA-1283 at Dose Level 1 on Day 1 and Day 29.
Group IV: mRNA-1273Experimental Treatment1 Intervention
Participants will receive 2 IM injections of mRNA-1273 at a pre-specified dose for this study on Day 1 and Day 29.
Group V: Placebo / mRNA-1283Experimental Treatment2 Interventions
Participants will receive 1 IM injection of study drug-matching placebo on Day 1 and 1 IM injection of mRNA-1283 at a pre-specified dose on Day 29. Participants may be offered an opportunity to receive an additional injection of mRNA-1273 at the pre-specified dose on Open-Label Day 1.
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
~58700
mRNA-1283
2021
Completed Phase 2
~650

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,379,213 Total Patients Enrolled
37 Trials studying COVID-19
61,260,462 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.

Could you outline the potential adverse effects of mRNA-1273?

"The safety of mRNA-1273 was assessed as a 1, due to the limited data available from Phase 1 trials attesting to its efficacy and security."

Answered by AI

Is this research novel in comparison to other similar studies?

"Since 2020, mRNA-1273 has been under scrutiny. Initially funded by ModernaTX Inc., the experimental drug underwent a Phase 3 trial of 30,000 patients in 2020 and was subsequently approved for use. Currently there are 25 studies running in 218 cities across 22 nations that examine this pharmaceutical further."

Answered by AI

Would I be eligible to join in this medical research project?

"This study calls for 104 participants, aged between 18-55 years old, afflicted with the pandemic virus. Eligible individuals must also possess a BMI of 18 to 35 kg/m^2 (inclusive), female patients of childbearing potential are expected to provide proof of contraception or abstinence from activities that could result in pregnancy at least 28 days prior to their first injection and 3 months after their second one; furthermore all applicants should be deemed healthy by the investigating physician and able to adhere to the trial's protocols."

Answered by AI

How many participants are involved in this clinical experiment?

"At this time, no further enrolment is being accepted for the trial initially posted on March 11th 2021 and last updated September 22nd 2022. However, there are currently 1022 clinical trials recruiting patients with Covid-19 and 25 studies actively seeking participants for mRNA-1273."

Answered by AI

Are elderly participants eligible for this trial?

"As stipulated by the enrollment prerequisites of this trial, participants must be between 18 and 55 in order to apply."

Answered by AI

Has there been prior research conducted with regards to mRNA-1273?

"mRNA-1273, initially examined in 2020 at Sundance Clinical Research, has since been tested extensively - 18334 completed trials to date. 25 of those are still active with multiple centres located in Peoria, Illinois."

Answered by AI

Is this research currently open to recruitment?

"Presently, this medical trial is not enrolling patients. The study was first released on March 11 2021 and last edited in September 22nd 2022. There are presently 1022 clinical trials involving Covid-19 that remain open for recruitment and an additional 25 studies focused around mRNA-1273 searching for participants."

Answered by AI

How widespread is the implementation of this research study?

"Presently, the trial is enrolling patients in 5 different regions. Optimal Research Illinois, LLC based in Peoria and Optimal Research Texas, LLC located in Austin are just a few of these areas. Additionally, there will be 3 more sites accepting participants."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Other
California
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Optimal Research San Diego, LLC
Optimal Research Illinois, LLC
Optimal Research Texas, LLC

Why did patients apply to this trial?

I think it is important to help with drug studies.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19
2021. "A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04813796.
~25 spots leftby Apr 2025
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