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

Eligibility Criteria

• 1. 18 to 29 years old.
• 2. Able to provide informed consent.
• 3. Willingness to allow storage of blood and saliva for future research.
• 4. In good general health as evidenced by medical history, physical examination, and laboratory screening results.
• 5. Participant is willing to forgo receipt of a licensed, live vaccine in the 30 days preceding each dose of vaccine or in the 30 days following each dose of vaccine. Any FDA-approved inactivated, subunit, or replication-defective vaccine (such as COVID-19, influenza, tetanus, etc.) can be used \>=14 days before or \>=14 days after administration of the study vaccine.
• 6. Participants of reproductive potential who are sexually active with a partner who can impregnate them: use of highly effective continuous contraception for at least 30 days prior to Day 0 and agreement to continue use until 60 days after the last dose of vaccine.
• * Intrauterine device (IUD) or equivalent.
• * Hormonal contraceptive (eg, consistent, timely, and continuous use of contraceptive pill, patch, ring, implant, or injection that has reached full efficacy prior to dosing). If the participant uses a contraceptive pill, patch, or ring, then a barrier method (eg, internal/external condom, cap, or diaphragm plus spermicide) must also be used at the time of potentially reproductive sexual activity.
• * A stable, long-term monogamous relationship with a partner who does not pose any potential pregnancy risk, eg, has undergone a vasectomy at least 6 months prior to the first dose of vaccine or is of the same sex as the participant.
• * A hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy.
• * External condom plus spermicide, used during sexual intercourse, even if the partner uses a contraceptive pill, patch, or ring.
• * A vasectomy completed at least 6 months before the first dose of vaccine.
• * Continuously and completely abstaining from sexual intercourse with a partner of childbearing potential from the first dose of vaccine until 30 days after the last dose.
• * IUD or equivalent.
• * Hormonal contraceptive (eg, pill, patch, ring, implant, or an injection used consistently and that has reached full effect prior to the first dose of vaccine).
• * Hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy.
• 1. Hemoglobin within institutional normal limits or if not, then assessed and deemed not clinically significant by PI or designee
• 2. White blood cell count and differential either within institutional normal reference range or if not then assessed and deemed not clinically significant by PI or designee
• 3. Total lymphocyte count (lymphocyte absolute) \> 800 cells/microL
• 4. Platelet count equal to 125,000-500,000/microL
• 5. Alanine aminotransferase \<1.25 x upper limit of normal (ULN)
• 6. Serum IgG \>600 mg/dL
• 1. Pregnant, breastfeeding, or planning to become pregnant while participating through 60 days after the last dose of vaccine.
• 2. Participant has received any of the following:
• 1. 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.
• 2. Blood products, including immunoglobulin products, within 120 days prior to first dose of vaccine.
• 3. Investigational research agents within 30 days prior to first dose or planning to receive investigational products while on study.
• 4. Allergy treatment with antigen injections, unless on a maintenance schedule of shots no more frequently than once per month.
• 5. Prior participant in an EBV vaccine clinical trial.
• 3. Participant has any of the following:
• 1. Febrile illness within 14 days of the first dose of vaccine.
• 2. Body habitus such that it is difficult to confirm location of the deltoid muscle for safe intramuscular injection.
• 3. History of serious reactions to vaccines.
• 4. Hereditary, acquired, or idiopathic forms of angioedema.
• 5. Idiopathic urticaria within the past year.
• 6. 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.
• 7. Diabetes mellitus type 1 or type 2, excluding a history of gestational diabetes.
• 8. Clinically significant autoimmune disease or immunodeficiency.
• 9. Hypertension that is not well-controlled.
• 10. Thyroid disease that is not well-controlled.
• 11. Bleeding disorder diagnosed by doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
• 12. Significant bruising or bleeding difficulties with intramuscular injections or blood draws.
• 13. 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.
• 14. 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.
• 15. Asplenia, functional asplenia, or any condition resulting in absence or removal of the spleen.
• 16. History of Guillain-Barre Syndrome.
• 17. Alcohol or drug abuse or addiction.
• 18. HIV infection.
• 4. Any medical, psychiatric, or social condition that, in the judgement of the investigator, is a contraindication to protocol participation or impairs the participant s ability to give informed consent.