Actively Recruiting
Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-07
750
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 29 years old
- Able to provide informed consent
- Willing to allow storage of blood and saliva samples for future research
- In good general health based on medical history, physical exam, and lab tests
- Willing to avoid licensed live vaccines within 30 days before or after each study vaccine dose
- If sexually active and able to become pregnant, willing to use highly effective contraception 30 days before and until 60 days after last vaccine dose
- Negative pregnancy test before each vaccine dose for participants of childbearing potential
- Meet specific lab criteria within 30 days before enrollment: hemoglobin, white blood cell count, lymphocyte count, platelet count, liver enzyme, and serum IgG levels within required limits
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy through 60 days after last vaccine dose
- Use of systemic immunosuppressive or cytotoxic medications within 30 days before first vaccine dose
- Receipt of blood products or immunoglobulins within 120 days before first vaccine dose
- Participation in other investigational treatments within 30 days before or during study
- Allergy treatment with antigen injections more frequent than once per month
- Prior participation in an EBV vaccine clinical trial
- Febrile illness within 14 days before first vaccine dose
- Body habitus making safe intramuscular injection difficult
- History of serious vaccine reactions
- Certain immune, allergic, or autoimmune conditions including angioedema, urticaria, poorly controlled asthma, diabetes, immunodeficiency, or autoimmune diseases
- Poorly controlled hypertension or thyroid disease
- Bleeding disorders or significant bleeding problems with injections or blood draws
- Active malignancy or recent cancer without assured cure
- Specific seizure disorders
- Absence or removal of the spleen
- History of Guillain-Barre Syndrome
- Alcohol or drug abuse
- HIV infection
- Any other medical, psychiatric, or social condition that may prevent safe participation or informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
Jessica R Durkee-Shock, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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