EBV Vaccine for EBV Infection
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have taken certain immunosuppressive or cytotoxic medications within 30 days before the first vaccine dose, and you should not receive investigational products while on the study.
What data supports the effectiveness of the EBV gH/gL/gp42-ferritin nanoparticle vaccine and EBV gp350-ferritin vaccine treatment?
How is the EBV nanoparticle vaccine treatment different from other treatments for EBV infection?
The EBV nanoparticle vaccine is unique because it combines multiple viral proteins (gp350 and gH/gL/gp42) into a self-assembling nanoparticle, which helps the body produce strong antibodies to block the virus from entering cells. Unlike previous vaccines that focused only on gp350, this approach targets multiple proteins to enhance protection against EBV infection and related cancers.12456
What is the purpose of this trial?
Background:Epstein-Barr virus (EBV) is the primary cause of infectious mononucleosis, commonly known as mono. EBV infects more than 90% of the world s population. Mono can be serious, and it can lead to severe illnesses like cancer and autoimmune diseases. Researchers want to test vaccines that may help prevent EBV and associated diseases.Objective:To test two EBV vaccines: EBV gH/gL/gp42-ferritin and EBV gp350-ferritin.Eligibility:Healthy EBV-negative or EBV-positive people aged 18 to 29.Design:Participants will be screened. They will have a physical examination. They will give blood and saliva samples.They will receive 3 doses of the study vaccine as an injection in the shoulder muscle. They will get either one vaccine or a combination of both vaccines.Participants will get their first dose of the vaccine at visit 1, the second dose about 30 days later, and the final dose about 90 days after that.Participants will be given a memory aid so they can record any symptoms and side effects between visits. This can be done either on paper or online through a link that is emailed to them.There are 6 required in-person visits. There are also 2 optional visits. In between the in-person visits are 7 telehealth visits or phone calls. Each visit may take up to 4 hours.The study will last for about 17 months. Participants will have the option of staying in the study for an additional year.
Research Team
Jessica R Durkee-Shock, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria
Healthy adults, both with and without prior Epstein-Barr Virus (EBV) infection, are eligible for this trial. The study is designed to assess the safety of a new EBV vaccine given in three doses over four months.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Initial phase where 9 EBV-seropositive individuals receive varying doses of the vaccine to assess safety
Randomization
Participants receive 3 doses of the vaccine at 0, 1, and 4 months
Follow-up
Participants are monitored for safety and effectiveness after the last dose of the vaccine
Open-label Extension (optional)
Participants may opt into continuation of monitoring for an additional year
Treatment Details
Interventions
- EBV gH/gL/gp42-ferritin nanoparticle vaccine
- EBV gp350-ferritin vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor