Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults

Completed · Phase 1

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

In brief

Background: Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Up to 1 in 10 people who get mono can have fatigue that lasts more than 6 months. One out of 100 people can have severe complications. EBV is also associated with several types of cancer. Researchers want to test an EBV vaccine. Objective: To test the safety of and immune response to a new vaccine against EBV. Eligibility: Healthy adults ages 18-29 Design: Participants will be screened with a medical history and physical exam. They will give a blood sample. Screening tests will be repeated during the study. Participants will get a dose of the study vaccine as an injection in a muscle in the upper arm. They will be observed for 30 to 60 minutes. Blood pressure, heart rate, breathing rate, and temperature will be checked. The injection site will be examined. Participants will get a diary card. They will write down any side effects they have after the vaccine dose, or they may use an electronic diary card. Participants will be asked to write down or enter any important medical events that may occur at any time during the study. Participants will get a vaccine dose at 2 more study visits. They will have 4 follow-up visits at different times after a vaccine dose. Participants will have 6 telephone calls in between the in-person visits. They will also have 1 telephone call 1 year after the third dose of vaccine. If possible, this visit can occur in person. Participation will last about 18 months. There is an optional in-person visit or telephone call 2 years after the third dose of vaccine.

Key facts

Study ID

NCT04645147

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

83

Starts

2022-03-29

Expected to finish

2026-04-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 29. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Women who are 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
• Any live attenuated vaccination within 30 days prior to first dose of vaccine
• Medically indicated subunit inactivated or replication-defective vaccines, e.g. influenza, pneumococcal, COVID-19 within 14 days of the 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.
• Participant has any of the following:
• Febrile illness within 14 days of the first dose of vaccine
• Obesity, in which any of the following are true:
• The deltoid muscle cannot be clearly identified
• Intramuscular (IM) vaccine administration/dosing may be compromised
• Presence of medical comorbidities such that enrollment is not in the best interests of the participant
• 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 (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
• Significant bruising or bleeding difficulties with IM injections or blood draws

Where it is running

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

Full record on ClinicalTrials.gov

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