Epstein-barr virus vaccines.
Jeffrey I Cohen
https://pubmed.ncbi.nlm.nih.gov/25671130Actively Recruiting
Phase 1
Age: 18Years - 29Years
All Genders
Healthy Volunteers
ID06908096
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-18
750
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a vaccine targeting the Epstein-Barr virus (EBV), the main cause of infectious mononucleosis (mono), which affects over 90% of the global population. The study aims to test two EBV vaccines, EBV gH/gL/gp42-ferritin and EBV gp350-ferritin, in healthy adults aged 18 to 29, whether they have had EBV before or not. The goal is to evaluate the safety and immune response generated by these vaccines to prevent EBV infection and related diseases. The study begins with a dose escalation phase involving 9 EBV-positive participants receiving varying doses and combinations of the vaccines, followed by a randomized phase where 54 participants are assigned to receive either one vaccine alone or both vaccines combined. Each participant will receive three doses of the vaccine injected into the shoulder muscle at the start, after one month, and then after four months. The vaccination is open-label, meaning participants and researchers know which vaccine they receive. Participants will attend six in-person visits over about 17 months, with additional optional visits and seven telehealth or phone check-ins to monitor health and record any symptoms or side effects. Blood and saliva samples will be collected, and participants will use a memory aid to track symptoms between visits. Researchers will measure reactions to the vaccine, antibody responses against EBV, and check for antibodies related to other bacteria and proteins. Participants may also choose to continue follow-up for an additional year after the study's main period.
CONDITIONS
Brief Title
Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection
Who Can Participate
Age: 18Years - 29Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 18 to 29 years old
- Able to provide informed consent
- Willing to allow storage of blood and saliva samples for future research
- In good general health based on medical history, physical exam, and lab results
- Agree to avoid licensed live vaccines 30 days before and after each study vaccine dose
- Use highly effective contraception if sexually active and able to impregnate or become pregnant
- Negative pregnancy test before each vaccine dose if of childbearing potential
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study and 60 days after last vaccine dose
- Use of systemic immunosuppressive or cytotoxic medications recently or immunomodulating therapy within 180 days
- Recent blood or immunoglobulin product transfusions
- Use of investigational agents recently or planned during the study
- Receiving allergy shots more frequently than once per month
- Prior participation in an EBV vaccine clinical trial
- Febrile illness within 14 days before first vaccine dose
- Body habitus preventing safe vaccine injection
- History of serious vaccine reactions
- Various immune, autoimmune, or blood disorders
- Uncontrolled asthma, diabetes, hypertension, or thyroid disease
- Active or recently treated cancer without assurance of cure
- Seizure disorders except specific exceptions
- Asplenia or absence of spleen
- History of Guillain-Barre Syndrome
- Alcohol or drug abuse
- HIV infection
- Any condition impairing ability to consent or participate as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 months
Participants receive three doses of the EBV gH/gL/gp42-ferritin nanoparticle vaccine with or without gp350-ferritin vaccine administered intramuscularly at 0, 1, and 4 months.
3 vaccination visits and weekly follow-up visits for 7 days after each vaccination
Follow-up
Duration - At least 12 months after the last dose
Participants are monitored for safety and immune response for at least 12 months after the third vaccine dose, with an option for an additional year of follow-up.
Visits at Day 30, Day 60, Day 150, and additional visits for up to 12 months or longer
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
J
Jessica R Durkee-Shock, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Rational Design of an Epstein-Barr Virus Vaccine Targeting the Receptor-Binding Site.
Masaru Kanekiyo, Wei Bu, M Gordon Joyce...
https://pubmed.ncbi.nlm.nih.gov/26279189A bivalent Epstein-Barr virus vaccine induces neutralizing antibodies that block infection and confer immunity in humanized mice.
Chih-Jen Wei, Wei Bu, Laura A Nguyen...
https://pubmed.ncbi.nlm.nih.gov/35507671