News Release

Friday, May 6, 2022

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched an initial clinical trial to evaluate a prophylactic vaccine against Epstein-Barr virus (EBV). EBV is a major cause of infectious mononucleosis and is associated with some cancers and autoimmune diseases. The Phase 1 study, to be conducted at the NIH Clinical Center in Bethesda, Maryland, is one of only two studies to test the EBV vaccine over a decade.

EBV is a member of the herpes virus family and is one of the most common viruses in humans. It is spread through body fluids, primarily saliva. Approximately 125,000 cases of infectious mononucleosis occur each year in the United States; 10% of these people experience fatigue for about six months or more. Approximately 1% of all people infected with EBV develop serious complications, including hepatitis, neurological problems, or severe blood abnormalities. EBV is also associated with several malignancies, including gastric and nasopharyngeal cancers and autoimmune diseases such as Hodgkin’s and Burkitt’s lymphoma, as well as systemic lupus erythematosus and multiple sclerosis.

“A vaccine that prevents or reduces infection with Epstein-Barr virus can reduce the incidence of infectious mononucleosis, as well as reduce the incidence of EBV-associated infectious and autoimmune diseases,” said NIAID Director Anthony S. Fauki, MD.

The study, led by Jessica Durki-Shock, chief researcher at NIAID’s Infectious Diseases Laboratory, evaluates the safety and immune response of the EBV gp350-Ferritin nanoparticle vaccine to saponin-based Matrix-M adjuvant. The experimental vaccine was developed by the Infectious Diseases Laboratory in collaboration with the NIAID Vaccine Research Center. The Matrix-M adjuvant was developed by the biotechnology company Novavax, based in Heathersburg, Maryland.

The vaccine targets gp350 EBV glycoprotein found on the surface of the virus and infected cells. EBV gp350 is also a major target in neutralizing antibodies found in the blood of people who are naturally infected with EBV. Ferritin, a natural iron-storing protein found in the cells of all living species, is a promising vaccine platform because it can display a dense mass of target virus proteins on its surface. The adjuvant is designed to boost the immune response caused by the research vaccine.

The study involved 40 healthy volunteers between the ages of 18 and 29, half of whom had a history of EBV infection and half who had no evidence of previous EBV infection.. Participants are given 50 injections of the experimental vaccine into the upper arm muscles three times, followed by a 30-60 minute follow-up after each dose. The second and third doses are administered 30 days and 180 days after the initial dose, followed by phone calls between subsequent visits and visits between vaccinations. Participation is expected to take 18 to 30 months, and litigation is required over the last four years. More information about the study is available at https://www.clinicaltrials.gov/ using the NCT04645147 identifier.

NIAID also supports research in the NIH, the United States, and around the world to study the causes of infectious and immune diseases and to develop better tools for the prevention, diagnosis, and treatment of these diseases. Messages, newsletters and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):The NIH, the country’s medical research agency, includes 27 institutes and centers and is part of the U.S. Department of Health and Human Services. The NIH is a major federal agency that conducts and supports basic, clinical, and translational medical research and studies the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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