A potential vaccine candidate for EBV and EBV-associated diseases like mono for adults

Trial ID: NCT05831111_PartB

The Equinox Trial is a Phase 1 clinical trial conducted by Moderna to evaluating the safety and immune response of an investigational vaccine aimed at protecting against Epstein-Barr Virus (EBV) and EBV-associated diseases like infectious mononucleosis (also known as mono).

Trial Details

The Equinox Trial is evaluating the safety and immune response of an investigational vaccine in protecting against EBV and mono.

Research is underway on an investigational vaccine to see if it can protect against EBV and EBV-associated diseases like mono or more serious conditions like post-transplant lymphoproliferative disorders (PTLDs). PTLDs are a group of diseases that resemble cancer and can occur following an organ or stem cell transplant. EBV may result in lifelong infection and the possibility of developing other diseases. Currently, there is no approved vaccine for EBV.

Estimated Enrollment

Approx. 120 Participants

Phase

1

Eligibility Criteria

Participants must:

Be 18 to 30 years of age
Be in generally good health
Be willing and able to comply with trial requirements

Participants must not:

Not be pregnant or chestfeeding

Site Locations

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

What to Expect

Participation in the Equinox Trial will last approximately 19 months and includes about 12 visits to a trial site and 11 safety phone calls.

Participants will be assigned at random to receive 1 of 3 variations of the investigational vaccine or a placebo, and they will receive 3 injections of their assigned treatment. In order to understand if the investigational vaccine works, medical researchers are comparing the mRNA-1195 investigational vaccine to a saltwater placebo (a solution that looks just like the investigational vaccine but contains no active vaccine).

All trial participants will receive the same level of quality care regardless of which investigational vaccine they receive.

Participants will be asked to use an electronic diary (eDiary) smartphone app to report any side effects on the day of each injection and for at least 6 days after. They will also use the eDiary to answer general questions about health events and symptoms of mono throughout the study.

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

Frequently Asked Questions (FAQs)

What are EBV and mono?

95% of people in the US get infected with Epstein-Barr virus (EBV) by age 35. Mono is most often associated with infection with EBV, which results in lifelong infection and the possibility of developing other diseases. can cause fever, tiredness (fatigue), sore throat, and swollen lymph nodes. EBV can also cause prolonged fatigue and sometimes an enlarged spleen, which can limit activity and, rarely, may require hospitalization. Currently, there is no approved vaccine for EBV.

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 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 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-1195 investigational vaccine contain a live virus?

The investigational vaccine being evaluated in this clinical trial is called mRNA-1195. 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 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, the most common cause of mono. You cannot get EBV or mono 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.