Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection

Recruiting now · Phase 1

Conditions studied: EBV, Epstein-Barr Virus Infection, Infectious Mononucleosis, Mono

In brief

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.

Key facts

Study ID

NCT06908096

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

750

Starts

2025-05-29

Expected to finish

2028-10-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older, up to 29. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Pregnant, breastfeeding, or planning to become pregnant while participating through 60 days after the last dose of vaccine.
• Participant has received any of the following:
• More than 10 days of systemic immunosuppressive medications (>=10 mg prednisone dose or its equivalent) or cytotoxic medication within the 30 days prior to first dose of vaccine or immunomodulating therapy within 180 days prior to first dose of vaccine.
• Blood products, including immunoglobulin products, within 120 days prior to first dose of vaccine.
• Investigational research agents within 30 days prior to first dose or planning to receive investigational products while on study.
• Allergy treatment with antigen injections, unless on a maintenance schedule of shots no more frequently than once per month.
• Prior participant in an EBV vaccine clinical trial.
• Participant has any of the following:
• Febrile illness within 14 days of the first dose of vaccine.
• Body habitus such that it is difficult to confirm location of the deltoid muscle for safe intramuscular injection.
• History of serious reactions to vaccines.
• Hereditary, acquired, or idiopathic forms of angioedema.
• Idiopathic urticaria within the past year.
• Asthma that is not well-controlled or required emergent care, urgent care, hospitalization, or intubation during the past 2 years or that requires the use of oral or intravenous steroids.
• Diabetes mellitus type 1 or type 2, excluding a history of gestational diabetes.
• Clinically significant autoimmune disease or immunodeficiency.
• Hypertension that is not well-controlled.
• Thyroid disease that is not well-controlled.
• Bleeding disorder diagnosed by doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
• Significant bruising or bleeding difficulties with intramuscular injections or blood draws.
• Malignancy that is active or treated malignancy for which there is no reasonable assurance of sustained cure or malignancy that is likely to recur during the study period.
• Seizure disorder other than a history of 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the past 3 years.
• Asplenia, functional asplenia, or any condition resulting in absence or removal of the spleen.
• History of Guillain-Barre Syndrome.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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