Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults With or Without EBV Infection

Inclusion Criteria

• •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• •1. 18 to 29 years old
• •2. Screening procedures and evaluations performed no more than 30 days prior to scheduled administration of the first vaccine dose.
• •3. Ability of subject to understand and the willingness to sign a written informed consent document.
• •4. Stated willingness to comply with all study procedures and availability for the duration of the active phase of the study (approximately 18 months)
• •5. Willingness to allow storage of blood and saliva for future research.
• •6. In good general health as evidenced by medical history, physical examination, and laboratory screening result.
• •7. Subject 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. An FDA-approved inactivated, subunit or replication-defective vaccine (such as COVID-19, influenza,
• •tetanus etc.) and/or a COVID-19 vaccine approved under emergency use authorization can be used \>=14 days before or \>=14 days after administration of the study vaccine.
• •8. For females of reproductive potential who are sexually active with a male partner: 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.
• •9. For males who are sexually active with partners of child-bearing potential: use of highly effective continuous contraception from Day 0 and agreement to continue use until 30 days after the last dose of vaccine.
• •Contraceptive requirements: Because the effects of EBV gp350-Ferritin vaccine on the developing human fetus are unknown, sexually active female participants of childbearing potential must agree to use highly effective contraception as outlined below before study entry and until 60 days after the last dose of vaccine. Females of childbearing potential must have a negative pregnancy test before receiving each dose of the EBV gp350-Ferritin vaccine. During the course of the study, if a participant becomes pregnant or suspects they are pregnant, then they should inform the study staff and their primary care physician immediately. Acceptable forms of contraception are:
• •* Intrauterine device (IUD) or equivalent
• •* Hormonal contraceptive (e.g. 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, path, or ring, then a barrier method (e.g. male/female 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, e.g. 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
• •Acceptable forms of contraception for male participants include one of the following:
• •* Condom plus spermicide, used before or during sexual intercourse, even if the female 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 female with child-bearing potential from the first dose of vaccine until 30 days after the last dose.
• •Acceptable contraception for female partners with child-bearing potential of male study participants include one of the following:
• •* IUD or equivalent
• •* Hormonal contraceptive (e.g. 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
• •Laboratory Criteria within 30 days or less prior to enrollment:
• •10. Hemoglobin within institutional normal limits or if not, then assessed and deemed not clinically significant by PI or designee
• •11. White blood cell (WBC) count and differential either within institutional normal reference range or if not then assessed and deemed not clinically significant by PI or designee
• •12. Total lymphocyte count (lymphocyte absolute) \>= 800 cells/mm3 (0.8 K/mcL)
• •13. Platelet count equal to 125,000 - 500,000/Mm\^3 (125-500 K/mcL)
• •14. Alanine aminotransferase (ALT) \<= 1.25x upper limit of normal (ULN)
• •15. Serum IgG \> 600 mg/dL
• •16. Negative human immunodeficiency virus (HIV) test.