CompletedPhase 3

A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants

United States234 participantsStarted 2021-04-16

Plain-language summary

This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT) and in healthy adult participants. The primary goal of the study is to evaluate the safety of mRNA-1273 and the serum antibody (Ab) responses obtained 28 days after the last dose of mRNA-1273.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. prior or planned administration of a coronavirus vaccine and current treatment with investigational agents for either prophylaxis against COVID-19.
. known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration or any known history of SARS-CoV-2 infection or positive SARSCoV-2 test will apply only to new SOT participants who will be enrolled in Part B.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Parts A and B: Number of SOT Participants With Unsolicited Adverse Events (AEs)

Timeframe: Up to 28 days post-vaccination

Parts A and B: Number of Healthy Participants With Unsolicited AEs

Timeframe: Up to 28 days post-vaccination

Parts A and B: Number of SOT Participants With Medically-Attended Adverse Events (MAAEs)

Timeframe: Throughout the study period (up to Day 450)

Parts A and B: Number of Healthy Participants With MAAEs

Timeframe: Throughout the study period (up to Day 394)

Parts A and B: Number of SOT Participants With Serious Adverse Events (SAEs)

Timeframe: Throughout the study period (up to Day 450)

Parts A and B: Number of Healthy Participants With SAEs

Timeframe: Throughout the study period (up to Day 394)

Parts A and B: Number of SOT Participants With Adverse Event of Special Interests (AESIs), Including Myocarditis/Pericarditis

Trial details

NCT IDNCT04860297

SponsorModernaTX, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-22

Results submitted2024-05-22

View on ClinicalTrials.gov More SARS-CoV-2 trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. prior or planned administration of a coronavirus vaccine and current treatment with investigational agents for either prophylaxis against COVID-19.
. known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration or any known history of SARS-CoV-2 infection or positive SARSCoV-2 test will apply only to new SOT participants who will be enrolled in Part B.

What they're measuring

Parts A and B: Number of SOT Participants With Unsolicited Adverse Events (AEs)

Timeframe: Up to 28 days post-vaccination

Parts A and B: Number of Healthy Participants With Unsolicited AEs

Timeframe: Up to 28 days post-vaccination

Parts A and B: Number of SOT Participants With Medically-Attended Adverse Events (MAAEs)

Timeframe: Throughout the study period (up to Day 450)

Parts A and B: Number of Healthy Participants With MAAEs

Timeframe: Throughout the study period (up to Day 394)

Parts A and B: Number of SOT Participants With Serious Adverse Events (SAEs)

Timeframe: Throughout the study period (up to Day 450)

Parts A and B: Number of Healthy Participants With SAEs

Timeframe: Throughout the study period (up to Day 394)

Parts A and B: Number of SOT Participants With Adverse Event of Special Interests (AESIs), Including Myocarditis/Pericarditis