Clinical Connection

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A COVID-19 vaccine research study for adults

A research study conducted by Moderna is testing an investigational vaccine that may protect adults aged 18-55 years from getting sick if they come into contact with SARS-COV-2, which causes COVID-19; also known as coronavirus.

Trial ID: NCT04813796

Trial Details

Researchers in the mRNA-1283-P101 study are testing if the mRNA-1283 investigational vaccine may be effective in preventing COVID-19.

The study is enrolling individuals who are 18-55 years old and are in good health. Participants in the study will receive either the mRNA-1283 study vaccine or the mRNA-1273 vaccine. mRNA-1283 is not currently authorized for preventing COVID-19.

Estimated Enrollment

125 Participants

Phase

Eligibility Criteria

Participants must:

Be at least 18 years old and no older than 55 years

Participants must not:

Be pregnant or breastfeeding
Have tested positive for COVID-19 or been in contact with anyone diagnosed with COVID-19 within 30 days prior to study vaccine administration
Have travelled outside of the United States within the last 28 days prior to screening for the study
Be receiving treatment with investigational agents for prevention of COVID-19 or treatment of COVID-19
Have received a COVID-19 vaccine
Have participated in another trial in the past month

What to Expect

Participation in the mRNA-1283-P101 study lasts approximately 14 months and includes phone calls with the study team and eight visits to the study site.

Participants will have two injection visits, which will be 28 days apart. Participants will receive either mRNA-1283 study vaccine or mRNA-1273 vaccine.
Participants will be asked to return to the study site one week, one month, six months and twelve months after the second shot.
Participants will be contacted by the study team once per month during the months that you do not have a study site visit to check how you are feeling and ask for updates on your health.
Participants will also be asked to complete monthly eDiary entries reporting any COVID-19 symptoms starting 6 weeks after the second dose of vaccine is received for the duration of the study.

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Actively Recruiting

Austin, Texas, United States
Chandler, Arizona, United States
Melbourne, Florida, United States
Peoria, Illinois, United States
San Diego, California, United States

Frequently Asked Questions (FAQs)

What is a clinical research study?

Clinical research studies include scientifically evaluated plans, or protocols, that outline how to test if a potential new medication or vaccine is safe and/or effective in people. All investigational medications and vaccines must be tested in clinical research studies before they can be submitted for approval by regulatory authorities. A clinical research study is conducted by doctors and researchers who follow strict guidelines to ensure the safety and wellbeing of the study volunteers who participate. Although side effects can occur in any clinical trial, the study is designed to minimize the risk and you will be monitored closely.

What are the phases of clinical research?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase 1 trials, researchers test a new vaccine, drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 trials, the study vaccine, drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the study vaccine, drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

Reference: https://www.ciscrp.org/education-center/important-information/#faq

Why is diversity important in clinical trials?

Clinical research studies and study volunteers are vital to creating a vaccine that will protect people of all ages and from all backgrounds against this devastating disease.

Given that certain populations and ages can respond differently to medical therapies, it is extremely important that this clinical research study include people of all ages, genders, races and ethnicities to ensure the vaccine is safe and effective for everyone to use.

Will compensation for time be available as part of this clinical trial?

Yes, compensation for your time will be available. We realize it takes time to come for study visits, so we want to make sure this is not too much of a burden for you. The study site will review these details with you.

Does the mRNA-1283 study vaccine contain a live virus?

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1283 study vaccine is different. It is made from an instructional molecule called mRNA that tells your cells how to make protein. In this case, the protein is a small part of the virus that is thought to help the body’s immune system protect itself if you ever come in contact with the coronavirus.

What happens if I am diagnosed with COVID-19 while in this trial?

You will be closely monitored by the study doctor and medical staff for symptoms of COVID-19 while in this study. If you are diagnosed with COVID-19 during the trial, the study team will notify your primary care physician and the study team will continue to monitor your well-being closely.

Can I get COVID-19 from the study vaccine being researched?

You cannot get infected with SARS-CoV-2 or get COVID-19 illness from the mRNA-1283 study vaccine.

Can I quit the trial at any time?

You have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the volunteer’s safety, or if the study volunteer no longer meets the study requirements.