NCT04645147

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

Active, enrolled Phase 1 Last updated 17 July 2025

What this trial tests

Phase 1 trial testing EBV gp350-Ferritin Vaccine in EBV in 83 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

29 March 2022

Primary endpoint
1 July 2025

1 July 2026

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	parallel
Masking	none
Primary purpose	other
Enrollment	83
Start date	29 March 2022
Primary completion	1 July 2025
Estimated completion	1 July 2026
Sites	1 location across United States

Drugs / interventions tested

• EBV gp350-Ferritin Vaccine — full drug profile →
• Matrix-M1 — full drug profile →

Conditions studied

• EBV — all drugs for EBV →
• Epstein-Barr Virus Infection — all drugs for Epstein-Barr Virus Infection →
• Infectious Mononucleosis — all drugs for Infectious Mononucleosis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 29, any sex, with EBV or Epstein-Barr Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vaccine adjuvants: mechanisms and platforms.
   Zhao T, Cai Y, Jiang Y, He X, et al · · 2023 · cited 519× · PMID 37468460 · DOI 10.1038/s41392-023-01557-7
2. Epstein-Barr virus: Biology and clinical disease.
   Damania B, Kenney SC, Raab-Traub N. · · 2022 · cited 395× · PMID 36113467 · DOI 10.1016/j.cell.2022.08.026
3. Nanotechnology's frontier in combatting infectious and inflammatory diseases: prevention and treatment.
   Huang Y, Guo X, Wu Y, Chen X, et al · · 2024 · cited 188× · PMID 38378653 · DOI 10.1038/s41392-024-01745-z
4. SARS-CoV-2 ferritin nanoparticle vaccines elicit broad SARS coronavirus immunogenicity.
   Joyce MG, Chen WH, Sankhala RS, Hajduczki A, et al · · 2021 · cited 169× · PMID 34919799 · DOI 10.1016/j.celrep.2021.110143
5. Functionalizing Ferritin Nanoparticles for Vaccine Development.
   Rodrigues MQ, Alves PM, Roldão A. · · 2021 · cited 81× · PMID 34683914 · DOI 10.3390/pharmaceutics13101621
6. An influenza hemagglutinin stem nanoparticle vaccine induces cross-group 1 neutralizing antibodies in healthy adults.
   Widge AT, Hofstetter AR, Houser KV, Awan SF, et al · · 2023 · cited 80× · PMID 37075129 · DOI 10.1126/scitranslmed.ade4790
7. A bivalent Epstein-Barr virus vaccine induces neutralizing antibodies that block infection and confer immunity in humanized mice.
   Wei CJ, Bu W, Nguyen LA, Batchelor JD, et al · · 2022 · cited 77× · PMID 35507671 · DOI 10.1126/scitranslmed.abf3685
8. Ferritin - a multifaceted protein scaffold for biotherapeutics.
   Lee NK, Cho S, Kim IS. · · 2022 · cited 66× · PMID 36192487 · DOI 10.1038/s12276-022-00859-0