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

The Eclipse Trial Part C is a Phase 2 clinical trial conducted by Moderna to evaluate the safety of and immune response to an investigational vaccine, called mRNA-1189, that aims to protect young adults ages 18-21 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, 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 spread, and people infected with mono experience a lot of challenges. They can spend up to two weeks in bed, which means missed appointments, missed work or school, and missing out on life in general.

Eligibility Criteria

Participants must:

  • Be 18 to 21 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
  • Have previously received an investigational EBV vaccine (e.g. mRNA-1189 or mRNA-1195)

Check Your Eligibility

We’ll check to see if you or your child may qualify for this clinical trial by asking you some questions.

Get Started

What to Expect

Participation in the Eclipse Trial will last approximately 19 months and includes 15 visits to a clinical trial site and 11 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 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, along with additional site visits and phone calls for health checks. This period lasts approximately 6 months.
  • Follow-up observation period: This period lasts up to 12 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 6 days after receiving each of the injections. During the Follow-up period, they will also answer general health questions in the app monthly.

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.

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

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.

We work with pharmaceutical and device companies to help bring new and more effective medications to those who need them. We conduct studies with deliberate concentration on knowledge, skills and integrity.

Here at Tekton, our staff ensures that every potential and current study participant is accurately qualified for the most appropriate study based on criteria.