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

NCT04645147 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-07-17

No results posted yet for this study

Summary

Background:

Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Up to 1 in 10 people who get mono can have fatigue that lasts more than 6 months. One out of 100 people can have severe complications. EBV is also associated with several types of cancer. Researchers want to test an EBV vaccine.

Objective:

To test the safety of and immune response to a new vaccine against EBV.

Eligibility:

Healthy adults ages 18-29

Design:

Participants will be screened with a medical history and physical exam. They will give a blood sample.

Screening tests will be repeated during the study.

Participants will get a dose of the study vaccine as an injection in a muscle in the upper arm. They will be observed for 30 to 60 minutes. Blood pressure, heart rate, breathing rate, and temperature will be checked. The injection site will be examined.

Participants will get a diary card. They will write down any side effects they have after the vaccine dose, or they may use an electronic diary card. Participants will be asked to write down or enter any important medical events that may occur at any time during the study.

Participants will get a vaccine dose at 2 more study visits. They will have 4 follow-up visits at different times after a vaccine dose.

Participants will have 6 telephone calls in between the in-person visits. They will also have 1 telephone call 1 year after the third dose of vaccine. If possible, this visit can occur in person.

Participation will last about 18 months. There is an optional in-person visit or telephone call 2 years after the third dose of vaccine.

Conditions

  • EBV
  • Epstein-Barr Virus Infection
  • Infectious Mononucleosis

Interventions

BIOLOGICAL

EBV gp350-Ferritin Vaccine

A 50 micrograms dose of EBV gp350-Ferritin vaccine will be administered intramuscularly for each vaccination at Days 0, 30, and 180 to all participants.

OTHER

Matrix-M1

Each vaccine dose will consist of 50 micrograms of EBV gp350-Ferritin combined with 49 micrograms of Matrix-M1.

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
NA
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2025-07-01
Completion
2026-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04645147 on ClinicalTrials.gov