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

90% of people in the US get infected with Epstein-Barr virus (EBV) by age 25. 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.

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.

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

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.

Qualified participants will receive payment for their trial-related time and travel.

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.

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 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.