Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin … (NCT06908096) | Clinical Trial Compass
RecruitingPhase 1
Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection
United States750 participantsStarted 2025-05-29
Plain-language summary
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.
Who can participate
Age range
18 Years – 29 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Local and systemic reactogenicity signs and symptoms during the 7-day period after each vaccination. Unsolicited AEs up to 30 days after each vaccination and SAEs through Day 150.
Timeframe: Through Day 150
Trial details
NCT IDNCT06908096
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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
Exclusion criteria
. Pregnant, 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.
. 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.
. Prior participant in an EBV vaccine clinical trial.