Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-seronegative Persons

• INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all the following criteria:

• Aged 18 to 25 years.

• Able to provide informed consent.

• Willing to allow samples and data to be stored for future secondary research.

• Stated willingness to comply with all study procedures and availability for theduration of the active phase of the study (approximately 18 months).

• In good general health as evidenced by medical history, physical examination, andlaboratory screening results.

• Willing to forgo receipt of a licensed, live vaccine in the 30 days before and 30days after each dose of the study vaccine. Any FDA-approved or authorizedinactivated and/or protein subunit, RNA, or DNA vaccine can be used >=14 days beforeor >=14 days after administration of the study vaccine.

• Hemoglobin within institutional normal limits, or if not, then assessed and deemednot clinically significant by PI or designee.

• White blood cell count and differential within institutional normal reference range,or if not, then deemed not clinically significant by PI or designee.

• Total lymphocyte count (lymphocyte absolute) >800 cells/microliters.

• Platelet count of 125,000 to 500,000/microliters.

• Alanine aminotransferase <1.25 x upper limit of normal.

• Participants who can get pregnant must agree to abstain from sexual activities thatcan result in pregnancy or use one of the following effective methods ofcontraception, starting 30 days before the first dose of study vaccine through 60days after the third dose:

• Intrauterine device (IUD) or equivalent.

• Hormonal contraceptive (eg, consistent, timely, and continuous use ofcontraceptive pill, patch, ring, implant, or injection that has reached fullefficacy before the first dose of study agent). If the participant uses acontraceptive pill, patch, or ring, then a barrier method (eg,internal/external condom, cervical cap, or diaphragm plus spermicide) must alsobe used at the time of potentially reproductive sexual activity.

• A hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy.

• Barrier method (eg, internal/external condom, cervical cap, or diaphragm) plusspermicide used correctly during sexual intercourse.

• A vasectomy in their monogamous sexual partner completed at least 6 monthsbefore the first dose of study vaccine.

• Continuous abstinence.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

• Pregnant or breastfeeding, or planning to become pregnant while participatingthrough 60 days after the third dose of study vaccine.

• Has received any of the following:

• More than 10 days of systemic glucocorticoids (>=10 mg of prednisone orequivalent) within the 30 days prior to first dose of study agent.

• More than 10 days of systemic immunosuppressive medications, cytotoxicmedications, or immunomodulating therapy within 180 days prior to first dose ofstudy agent.

• Blood products, including immunoglobulins, within 120 days prior to first doseof study agent.

• Any live attenuated vaccination within 30 days prior to first dose of studyagent.

• Investigational research agents within 30 days prior to first dose or planningto receive investigational products while on study.

• Allergy treatment with antigen injections, unless on a maintenance schedule ofshots no more frequently than once per month.

• Has any of the following:

• Febrile illness within 14 days of the first dose of study agent.

• Body habitus such that identification of the deltoid muscle and/oradministration of vaccine into the deltoid would be compromised or if bodyhabitus would make study inclusion not in the best interest of the participant.

• 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 that required emergency care, urgentcare, hospitalization, or intubation during the past 2 years, or that requiresthe use of oral or intravenous steroids.

• Diabetes mellitus type 1 or type 2, excluding a history of gestationaldiabetes.

• Clinically significant autoimmune disease or immunodeficiency.

• Bleeding disorder diagnosed by doctor (eg, factor deficiency, coagulopathy, orplatelet disorder requiring special precautions).

• Significant bruising or bleeding difficulties with intramuscular injections orblood draws.

• Malignancy that is active or treated malignancy for which there is noreasonable assurance of sustained cure or malignancy that is likely to recurduring the study period.

• Seizure disorder other than a history of 1) febrile seizures, 2) seizuressecondary to alcohol withdrawal more than 3 years ago, or 3) seizures that havenot required treatment within the past 3 years.

• Asplenia, functional asplenia, or any condition resulting in absence or removalof the spleen.

• History of Guillain-Barre Syndrome.

• Alcohol or drug abuse or addiction.

• HIV infection.

• Active hepatitis B or C infection.

• Documented EBV infection.

• Prior enrollment in an EBV vaccine clinical trial.

• Any medical, psychiatric, or social condition that, in the judgement of theinvestigator, is a contraindication to protocol participation or impairs theparticipant s ability to give informed consent.

Co-enrollment guidelines:

Co-enrollment in other studies is restricted, other than enrollment on observational studies. Consideration for co-enrollment in trials evaluating the use of a licensed medication will require the approval of the PI or sponsor medical monitor (SMM). Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the PI or SMM.