A clinical trial of an investigational norovirus vaccine for adults

Trial ID: mRNA-1403-P301

The Nova 301 Trial is a Phase 3 clinical trial being conducted by Moderna to evaluate the safety, effectiveness, and immune response of an investigational vaccine, called mRNA-1403, aimed at preventing norovirus disease in adults.

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Trial Details

The purpose of the Nova 301 Trial is to evaluate the safety, effectiveness, and immune response of an investigational vaccine, called mRNA-1403, which aims to protect adults against norovirus disease.

Norovirus, often called “food poisoning” or the “stomach bug”, can cause major disruptions to your daily life. Symptoms can include sudden nausea, vomiting, diarrhea, stomach pain, feeling tired or weak, muscle pains, and fever. These symptoms, often known as acute gastroenteritis (AGE), generally last for 1 to 3 days. In severe cases, these symptoms can lead to dehydration, which may require hospitalization or IV fluids.

Norovirus spreads quickly through interactions in places like day care centers, retirement communities, cruise ships, and restaurants. Children under age 5, adults over age 60, and people with underlying health conditions are at greater risk of serious symptoms of norovirus.

mRNA-1403 is a messenger RNA (mRNA)- based vaccine. mRNA vaccines aim to teach the body how to make a specific protein that may potentially help your immune system prevent or treat certain diseases. The hope is that the vaccine trains your immune system cells to “remember” these proteins and help your body quickly protect against the strain of infection if exposed in the future. You cannot get norovirus from the investigational vaccine.

Estimated Enrolment

Approximately 25,000 Participants

Phase

3

Eligibility Criteria

Participants must:

Be 18 years of age or older
Be in generally good health, including well-controlled chronic medical conditions

Participants must not:

Be pregnant or planning on becoming pregnant for at least 3 months following the injection visit

Site Locations

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

What to Expect

Participation in the Nova 301 Trial will last approximately 2 years and includes at least 6 in-person visits to a trial site and 6 safety phone calls.

You will be randomly assigned, like flipping a coin, to receive either the investigational vaccine, called mRNA-1403, or a placebo. A placebo does not include any active ingredients and is compared to the investigational vaccine to understand whether the investigational vaccine works and is safe. All participants will receive the same level of trial-related care regardless of which injection they receive.

Each participant will be given 1 injection in the upper arm. Participants will be asked to regularly use an eDiary app on their smartphone (or a provided device) to report any side effects or acute gastroenteritis (AGE) symptoms they might experience every day for 7 days, starting on the day of injection, and at least weekly thereafter. If you have any AGE symptoms such as vomiting or diarrhea, you will also be asked to complete an eDiary entry as soon as your symptoms begin and fill out additional questionnaires for 7 days afterwards. If you have AGE symptoms, you may be asked to provide a stool sample.

Insurance is not needed to participate, and qualified participants will receive payment for their trial-related time and travel.

Frequently Asked Questions (FAQs)

What is norovirus?

Norovirus, sometimes called ‘food poisoning’ or the ‘stomach bug’, is an extremely contagious virus that can spread quickly through everyday social interactions causing a quick onset of symptoms like nausea, vomiting and diarrhoea. These symptoms, often known as acute gastroenteritis (AGE), usually last 1 to 3 days. In severe cases these symptoms can lead to dehydration which may require hospitalisation or IV fluids. While norovirus can infect people of all ages, vulnerable people such as children under age 5, adults over age 60, and people with underlying health conditions are at greater risk of serious symptoms. Norovirus is the leading cause of acute gastroenteritis.

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 analysed.

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, medicine 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, medicine 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, medicine 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 medicine or treatment to be used safely. - In Phase 4 trials, post marketing studies delineate additional information including the medicine’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-1403 investigational vaccine contain a live virus?

No, the mRNA-1403 investigational vaccine does not contain a live virus. Unlike vaccines that are made from weakened or killed viruses, mRNA-1403 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 investigational vaccine is that the protein will trigger the body’s immune system to create the antibodies it needs to fight the real norovirus, should it later enter your body. You cannot get norovirus from the mRNA-1403 investigational vaccine.

How can I check to see if I am eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

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.