A clinical trial of an Epstein-Barr virus (EBV) vaccine for teens

Trial ID: NCT05164094 (Part B)

The Eclipse Trial is a Phase 1 clinical trial conducted by Moderna to evaluate the safety of and immune response to an investigational vaccine, called mRNA-1189, that aims to protect teens ages 12–17 against Epstein-Barr virus (EBV) and infectious mononucleosis (mono).

Trial Details

The Eclipse Trial is evaluating the safety and immune response of an investigational vaccine, called mRNA-1189, which aims to protect against Epstein-Barr virus (EBV) and infectious mononucleosis (mono). An investigational vaccine is a vaccine that has not been approved by a country’s regulatory agency, like the U.S. Food and Drug Administration (FDA).

Mono can cause fever, tiredness (fatigue), sore throat, and swollen lymph nodes. It can also cause prolonged fatigue and sometimes an enlarged spleen, which can limit activity and, rarely, may require hospitalization. Mono is most often associated with EBV infection, which results in lifelong infection and the possibility of developing other diseases. Currently, there is no approved vaccine for EBV.

Mono is easily transmissible and causes those who are infected a lot of hardship and inconveniences. People can spend up to two weeks in bed, which means missed appointments, missed work or school, and missing out on life in general.

Estimated Enrollment

150 Participants

Phase

1

Eligibility Criteria

Participants must:

Be 12 to 17 years of age
Be in generally good health
Be willing and able to comply with trial requirements

Participants must not:

Have been exposed to someone with COVID-19 within 14 days before screening
Be pregnant or breastfeeding

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 Eclipse Trial will last approximately 19 months and includes 15 visits to a clinical trial site and 10 phone calls with the clinical trial team.

Participants will be given a total of 3 injections in the upper arm, each during separate visits.

Participants will be randomly assigned to receive 1 of 4 different dose amounts of the investigational mRNA-1189 vaccine or a placebo. A placebo is a solution that contains no active ingredients and is used as a comparison to understand whether the investigational vaccine works and is safe. All clinical trial participants will get the same level of trial-related care regardless of which injection or dose they receive.

Participation in the Eclipse Trial includes 3 parts:

Screening: During this period, which lasts up to 28 days, the trial team performs tests and procedures to make sure the clinical trial is a good match for the potential participant.
Dosing period: During this period, the participant has 3 injection visits to receive the investigational vaccine or the placebo. This period lasts approximately 6 months.
Follow-up observation period: This period lasts up to 11 months after the last dose of the investigational vaccine or placebo. During this period, the participant monitors their health for side effects and mono symptoms.

Participants will be asked to use an eDiary app on their smartphone (or a provided device) to report any side effects they might experience every day for 7 days after receiving each of the injections.

Insurance is not needed 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 are Epstein-Barr Virus and Infectious Mononucleosis?

Infectious mononucleosis (IM), commonly known as mono, is an infection that presents with fever, fatigue, sore throat, and enlarged lymph nodes, and can result in prolonged symptoms as well as hospitalization. Approximately 90% of mono infections are caused by Epstein-Barr virus (EBV), which is one of the most common human viruses.

What is a clinical trial?

Clinical trials are carefully controlled scientific studies that evaluate if investigational 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 of the condition?

A clinical trial follows a protocol that has been approved by regulatory agencies, such as the U.S. Food and Drug Administration, 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-1189 investigational vaccine contain a live virus?

Often vaccines are made from a weakened or inactive (not live) viruses, but the mRNA-1189 investigational vaccine is different. It is made from an instructional molecule called mRNA. mRNA makes specific proteins inside your cells, triggering the body’s immune system to create antibodies against them. Through this natural process, it is hoped that the immune system can create the antibodies it needs to defend against EBV in case you later come into contact with the real virus. You cannot get EBV or mono from the mRNA-1189 investigational vaccine because it does not contain the actual virus.

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 completely 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.