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 early-stage clinical trial to evaluate a preventive vaccine in research for Epstein-Barr virus (EBV). VEB is the leading cause of infectious mononucleosis and is associated with certain cancers and autoimmune diseases. The Phase 1 study, which will be conducted at the NIH Clinical Center in Bethesda, Maryland, is one of only two studies to test a research vaccine against EBV in more than a decade.
EBV is a member of the herpes virus family and one of the most common human viruses. It is transmitted through body fluids, mainly saliva. It is estimated that 125,000 cases of infectious mononucleosis occur each year in the United States; about 10% of these people develop fatigue that lasts six months or more. Approximately 1% of all EBV-infected individuals develop serious complications, such as hepatitis, neurological problems, or severe blood abnormalities. EBV is also associated with several malignancies, such as stomach and nasopharyngeal cancers and Hodgkin’s and Burkitt’s lymphomas, as well as autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis.
“A vaccine that could prevent or reduce the severity of Epstein-Barr virus infection could reduce the incidence of infectious mononucleosis and could also reduce the incidence of EBV-associated malignancies and autoimmune diseases,” said the director. of NIAID Anthony S. Fauci, MD.
Led by lead researcher Jessica Durkee-Shock, MD, of NIAID’s Infectious Diseases Laboratory, the study will evaluate the safety and immune response of an EBV gp350-Ferritin nanoparticle vaccine in research with a Matrix-M-based adjuvant. saponin. 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 Gaithersburg, Maryland.
The vaccine works by targeting the EBV gp350 glycoprotein, which is found on the surface of the virus and in cells infected with the virus. EBV gp350 is also the primary target for neutralizing antibodies found in the blood of people naturally infected with EBV. Ferritin, a naturally occurring iron storage protein found in the cells of all living species, is considered a promising vaccine platform because it can display target virus proteins in a dense matrix on its surface. The adjuvant aims to enhance the vaccine-induced immune response under investigation.
The study will include 40 healthy adult volunteers between the ages of 18 and 29, half of whom have evidence of previous EBV infection and half of whom have no evidence of previous EBV infection.. Participants will receive a series of three 50-microgram injections of the experimental vaccine into the upper arm muscle, followed by 30 to 60 minutes of observation after each dose. The second and third doses will be given 30 days and 180 days after the initial dose, with follow-up visits between each vaccination and phone calls between visits. Participation is expected to take between 18 and 30 months and the trial is expected to last four years. More information about the study is available at https://www.clinicaltrials.gov/ using ID NCT04645147.
NIAID conducts and supports research — at the NIH, in the United States, and around the world — to study the causes of infectious and immunomediated diseases and to develop better ways to prevent, diagnose, and treat these diseases. News releases, fact sheets, and other NIAID-related materials are available on the NIAID website.
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