Phase 1 Study of the Safety of an Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection
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.
‣ To be eligible to participate in this study, an individual must meet all of the following criteria:
⁃ 18 to 29 years old.
⁃ Able to provide informed consent.
⁃ Willingness to allow storage of blood and saliva for future research.
⁃ In good general health as evidenced by medical history, physical examination, and laboratory screening results.
⁃ 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.
⁃ 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.
‣ Contraceptive requirements: Because the effects of EBV gH/gL/gp42-FNP and EBV gp350-ferritin vaccines on the developing human fetus are unknown, sexually active 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. Participants of childbearing potential must have a negative pregnancy test before receiving each dose of the EBV gH/gL/gp42-FNP 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 (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.
‣ Acceptable forms of contraception for participants who can impregnate a partner include one of the following:
• 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.
‣ Acceptable contraception for partners of childbearing potential of participants who can impregnate them include one of the following:
• 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.
‣ Laboratory Criteria within 30 days or less prior to enrollment:
⁃ Hemoglobin within institutional normal limits or if not, then assessed and deemed not clinically significant by PI or designee
⁃ 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
⁃ Total lymphocyte count (lymphocyte absolute) \> 800 cells/microL
⁃ Platelet count equal to 125,000-500,000/microL
⁃ Alanine aminotransferase \<1.25 x upper limit of normal (ULN)
⁃ Serum IgG \>600 mg/dL