An Epstein-Barr Virus (EBV) vaccine clinical trial

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.

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 the FDA and other regulatory agencies in order to ensure patients’ and trial volunteers’ 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.

All new treatments and vaccines must go through several stages of research (also called “phases”) in order to determine if the new treatment or vaccine is safe and effective in people. Clinical trials are usually conducted in four phases that build on one another, with each phase designed to answer certain questions.

• Preclinical Research: Before testing in people, investigational treatments undergo laboratory and animal testing to answer basic questions about safety.
• Phase 1: A trial of a small number of participants to evaluate the safety and dosage of an investigational treatment or vaccine and gather information on how it interacts with the body.
• Phase 2: A trial of a slightly larger group of participants to further evaluate how an investigational treatment or vaccine affects the body, gather additional safety data, and monitor side effects.
• Phase 3: A trial with the largest number of participants to determine efficacy of an investigational treatment or vaccine and compare it to existing treatments, vaccines, or placebo. A Phase 3 trial continues to monitor side effects and collect safety data. This is the final step before submitting an investigational product to a regulatory agency for market approval.
• Regulatory Agency Review: Regulatory agencies, such as the FDA in the United States, review data from the clinical trial and determine if the investigational treatment or vaccine is effective and safe for use in people. To get approved, the new treatment or vaccine must be determined to provide benefits that outweigh its known and potential risks for the intended population.
• Phase 4: After receiving approval, the treatment or vaccine is made available for use. Phase 4 trials are used for post-marketing observation. Sometimes, they may be used to study the medicine in a different group of people or in another illness or disease than was previously studied. Not all medications and treatments will require a Phase 4 trial.

Reference: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process

Clinical trials and study volunteers are vital to creating a vaccine that will protect people of all ages and from all backgrounds.

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

Yes, compensation for participants’ trial-related time spent will be available. The clinical research staff will review these details with participants.

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1189 investigational vaccine is different. It is made from an instructional molecule called mRNA that tells your cells how to make protein. In this case, the protein is a small part of the virus that is thought to help the body’s immune system protect itself if you ever come in contact with the Epstein-Barr Virus (EBV).

In order to better know if the investigational treatment or vaccine works, researchers may compare the investigational treatment or vaccine to an inactive drug called a placebo, which can be a sugar pill or saltwater solution. A placebo looks like the investigational treatment or vaccine being tested but does not contain an active ingredient.

All participants receive the same level of quality care regardless of whether they are assigned to the investigational treatment or vaccine, or the placebo.

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.

Participation in any clinical trial is completely voluntary. Participants have the right to drop out of the trial at any time and for any reason (and they do not need to give a reason). The clinical trial doctor or clinical research sponsor also has the right to discontinue a participant at any time for the participant’s safety or if the participant no longer meets the clinical trial requirements.