A clinical trial of an investigational COVID-19 vaccine for adults and teens 12 years of age or older

Trial ID: NCT05815498 NextCOVE Pt.3

The NextCOVE Study is a Phase 3 clinical trial being conducted by Moderna to evaluate an investigational vaccine, mRNA-1283, to see if it can protect adults and teens 12 years of age or older from COVID-19.

Trial Details

The purpose of the NextCOVE Study is to evaluate an investigational COVID-19 vaccine that may protect adults and teens 12 years of age or older from getting sick if they come into contact with the virus that causes COVID-19, including the Omicron (XBB.1.5) variant.

Part 3 of the NextCOVE Study is evaluating the safety and immune response of the investigational COVID-19 vaccine mRNA-1283.815, when compared to the COVID-19 vaccine mRNA-1273.815. By comparing the investigational vaccine mRNA-1283 to the approved vaccine mRNA-1273, medical researchers may be able to understand if it is effective in potentially preventing illness from COVID-19.

mRNA-1283 is a messenger (mRNA)-based investigational vaccine. It is made from messenger RNA (mRNA), an instructional molecule that naturally occurs in the body and tells cells how to make protein. The goal of this vaccine is for the protein to trigger the body’s immune system to create the antibodies it needs to potentially fight the real SARS-CoV-2 virus, which causes COVID-19.

Estimated Enrollment

Approximately 13,600 Participants

Phase

3

Eligibility Criteria

Participants must:

Be 12 years of age or older
Provide proof of vaccination if you or your teen has been previously vaccinated

For some participants, no prior vaccination is required

Participants must not:

Have had a positive COVID-19 test within 90 days prior to the screening visit
Have received a COVID-19 vaccine within 90 days prior to the screening visit

Site Locations

Participants will need to go to one of the clinics taking part in this clinical trial.

Sites are located in the cities/states identified with the red pin:

What to Expect

Participation in the NextCOVE Study will last approximately 7 months and includes up to at least 5 in-person visits to a trial site and up to 2 safety phone calls.

You or your teen will be chosen at random to receive either the original COVID-19 vaccine, mRNA-1273, or the investigational COVID-19 vaccine, mRNA-1283.

Each participant will be given 1 injection in the upper arm or thigh.

After receiving the injection, you or your teen will be asked to complete electronic diary (eDiary) entries for 7 days, starting on and including the day of injection, to report any COVID-19 symptoms that may occur.

Insurance is not required to participate, and all trial-related procedures and exams will be covered at no cost. Qualified participants will receive payment for their trial-related time and travel.

Frequently Asked Questions (FAQs)

What is COVID-19?

COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. Common symptoms are similar to the flu and include fever, cough, and tiredness. More serious symptoms include difficulty breathing and loss of speech or mobility. COVID-19 was first identified in December 2019. Since that time until early 2024, according to the World Health Organization, there have been more than 700 million cases and 7 million deaths worldwide.

What is a clinical trial?

Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. Clinical trials are conducted to answer questions such as:

Is the investigational treatment or vaccine safe enough to outweigh the risks?
What is the best dose needed for the investigational treatment or vaccine to work?
How often should the investigational treatment or vaccine be given?
How effective is the investigational treatment or vaccine at treating or preventing symptoms or the condition?

A clinical trial follows a protocol that has been approved by regulatory agencies to ensure patients’ and trial participants’ safety. The protocol outlines the types of trial participants to include, the schedule of visits and procedures, safety precautions, and what and how data will be analyzed.

What are the phases of clinical trials?

Clinical trials are conducted in phases. Each phase of the trial has a different purpose and helps scientists answer different questions:

In Phase 1 trials, researchers test an investigational 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 investigational 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 investigational 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 trials and trial volunteers are vital to advancing research of an investigational vaccine that may potentially protect people of all ages and from all backgrounds.

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

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

Qualified participants will receive payment for their trial-related time and travel.

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

The investigational vaccine being evaluated in this clinical trial is called mRNA-1283. Unlike vaccines that are made from weakened or killed viruses, mRNA-1283 is made from messenger RNA (mRNA), an instructional molecule that naturally occurs in the body and tells cells how to make specific protein. The goal of this vaccine is that the protein will trigger the body’s immune system to create the antibodies it needs to fight the real virus that causes COVID-19, should it ever enter your body. You cannot get COVID-19 from the mRNA-1283 investigational vaccine.

Can I remove myself from the trial at any time?

Participation is voluntary. You have the right to end your participation in the clinical trial at any time for any reason, or no reason at all. The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements.

This trial is not actively recruiting.