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Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-seronegative Persons

NCT05683834 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-22

No results posted yet for this study

Summary

Background:

Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Mono can cause fatigue that lasts more than 6 months, and some people can have severe complications. EBV infection may also contribute to some cancers and autoimmune diseases. Currently, there are no approved therapies or vaccines for EBV infection.

Objective:

To test a vaccine against EBV.

Eligibility:

Healthy people aged 18 to 25 years.

Design:

Participants will be screened in 2 parts. They will have a blood test. If that test shows they have never had an EBV infection, they will have a second clinic visit. They will have a physical exam, with blood and urine tests. A cotton swab will be rubbed on their gums to collect saliva.

Participants will receive 2 injections into a shoulder muscle. Some will receive the EBV vaccine. Others will receive a placebo; this contains harmless salt water with no vaccine. Participants will not know which one they are getting. The 2 injections will be 30 days apart.

Participants will be asked to record any side effects or symptoms they have between visits. They can do this on paper or online.

Participants will return for a follow-up visit 60 days after the first injection. They will have follow-up visits by phone or telehealth after 5 and 8 months. They will return for a physical exam after 13 months. They may come back for an optional physical exam after 2 years.

Participants will come to the clinic if they become ill with an EBV infection during the study.

Conditions

  • Epstein-Barr Virus Infection
  • Infectious Mononucleosis
  • Herpesvirus

Interventions

DRUG

Matrix-M1 Adjuvant

Matrix-M1 is composed of 2 types of 40 nm-sized particles each with a different saponin fraction (fraction A and fraction B) combined with cholesterol and phospholipid.

DRUG

EBV gp350-Ferritin Vaccine

The EBV gp350-Ferritin vaccine is composed of Helicobacter pylori non-heme ferritin fused to EBV gp350 which self-assembles to form a nanoparticle. The vaccine is supplied in single-use vials at a concentration of 250 micrograms/mL in 1.7 mM KH2PO4, 5 mM Na2HPO4, 150 mM NaCl, 5% sucrose, pH 7.4 (diluent).

OTHER

Placebo Comparator

Normal Saline

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
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2026-04-01
Completion
2026-04-20
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 NCT05683834 on ClinicalTrials.gov