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Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection

NCT06908096 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • EBV
  • Epstein-Barr Virus Infection
  • Infectious Mononucleosis
  • Mono

Interventions

BIOLOGICAL

EBV gp350-ferritin vaccine with ALFQ adjuvant

The adjuvanted gH/gL/gp42-ferritin nanoparticle vaccine is given with gp350-ferritin intramuscularly into the deltoid muscle at 0, 1, and 4 months.

BIOLOGICAL

EBV gH/gL/gp42-ferritin nanoparticle vaccine with ALFQ adjuvant

The adjuvanted gH/gL/gp42-ferritin nanoparticle vaccine is given with gp350-ferritin intramuscularly into the deltoid muscle at 0, 1, and 4 months.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jessica R Durkee-Shock, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2027-10-01
Completion
2028-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06908096 on ClinicalTrials.gov