A clinical trial of an investigational Epstein-Barr virus (EBV) vaccine for adults ages 18 – 55 with multiple sclerosis

Trial ID: mRNA-1195-P201

The Horizon Trial is a Phase 2 clinical trial being conducted by Moderna to evaluate the safety and effectiveness of an investigational vaccine, called mRNA-1195, aimed at preventing Epstein-Barr virus (EBV) in adults ages 18 – 55 with multiple sclerosis (MS) to see if it can stop or slow MS symptoms from progressing.

Trial Details

The purpose of the Horizon Trial is to evaluate the safety and effectiveness of an investigational vaccine, called mRNA-1195, aimed at preventing EBV in adults ages 18 – 55 with MS to see if it can stop or slow MS symptoms from progressing.

EBV can trigger multiple sclerosis or make your symptoms worse. Most people with MS have EBV, and research shows that EBV is a contributing cause of MS. Researchers are working to better understand the relationship between EBV and MS. There is currently no vaccine to prevent EBV infection.

mRNA-1195 is an investigational messenger RNA (mRNA)- based vaccine. An mRNA vaccine aims to teach the body how to make a specific protein that may potentially help your immune system prevent or treat certain diseases and illnesses. The hope is that the investigational vaccine trains your immune system cells to “remember” these proteins and helps your body prevent EBV from activating and spreading to other cells in your body.

Estimated Enrollment

180 Participants

Phase

2

Eligibility Criteria

Participants must:

Be 18 to 55 years of age
Have been diagnosed with MS, clinically isolated syndrome (CIS)*, or radiologically isolated syndrome (RIS) † within the last 2 years

*CIS is when you have had 1 episode of MS symptoms with brain or spinal cord images typical to MS.

† RIS is when you have no MS symptoms yet, but your brain or spinal cord images are typical to MS.

Participants must not:

Be pregnant or planning on becoming pregnant until after the final injection visit

Site Locations

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

What to Expect

Participation in the Horizon Trial will last approximately 30 months (2 ½ years) and includes at least 14 in-person visits to a trial site and 21 safety phone calls.

You will be randomly assigned, like flipping a coin, to receive either the investigational vaccine, called mRNA-1195, or placebo. To understand whether the investigational vaccine works and is safe, it will be compared with a placebo. A placebo looks like the investigational vaccine but has no active ingredients.

Each participant will be given a total of 3 injections in the upper arm, each during a separate visit.

Participants will be asked to use an eDiary app on their smartphone (or a provided device) to enter information about reactions and how they are feeling every day for 7 days after each injection. Participants will have 12 MRI scans throughout the clinical trial.

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 Epstein-Barr virus (EBV)?

Epstein-Barr virus (EBV) is a common virus that infects up to 95% of adults worldwide, and research shows EBV is a contributing cause of multiple sclerosis (MS). EBV is the most common cause of mononucleosis, or ‘mono’, which can cause fever, tiredness, sore throat, and swollen lymph nodes. However, an EBV infection often has no symptoms and once you are infected, the virus remains “hidden” in your body for life. At times, it can become active again. There is currently no vaccine to prevent EBV infection.

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 efficacy, 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-1195 investigational vaccine contain a live virus?

The investigational vaccine being evaluated in this clinical trial is called mRNA-1195, which does not contain a live virus. Unlike vaccines that are made from weakened or killed viruses, mRNA-1195 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 Epstein-Barr virus (EBV), should it later enter your body. You cannot get EBV from the mRNA-1195 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.