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 an experimental preventative vaccine against the Epstein-Barr virus ( EBV). EBV 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 an experimental EBV vaccine in more than a decade.
EBV is a member of the herpes virus family and one of the most common human viruses. It spreads through bodily fluids, mainly saliva. An estimated 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. About 1% of all people infected with EBV develop serious complications, including hepatitis, neurological problems, or serious blood abnormalities. EBV is also associated with several malignancies, including gastric and nasopharyngeal cancers and Hodgkin’s and Burkitt’s lymphomas, as well as autoimmune diseases, such as systemic lupus erythematosus and multiple sclerosis. plates.
“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 malignancies and autoimmune diseases associated with ‘EBV,’ said Anthony S. Fauci, MD, director of NIAID.
Led by Principal Investigator Jessica Durkee-Shock, MD, of NIAID’s Infectious Diseases Laboratory, the study will assess the safety and immune response of an experimental EBV gp350-ferritin nanoparticle vaccine with a Matrix-M adjuvant. based on saponin. The experimental vaccine was developed by the Infectious Diseases Laboratory in collaboration with NIAID’s 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 glycoprotein gp350, which is found on the surface of the virus and virus-infected cells. EBV gp350 is also the main target of neutralizing antibodies present in the blood of people naturally infected with EBV. Ferritin, a natural iron storage protein found in cells of all living species, is considered a promising vaccine platform because it can display the proteins of the targeted virus in a dense network on its surface. The adjuvant is intended to reinforce the immune response induced by the experimental vaccine.
The study will recruit 40 healthy adult volunteers between the ages of 18 and 29, half of whom have evidence of prior EBV infection and the other half have no evidence of prior EBV infection.. Participants will receive a series of three injections of 50 micrograms of the experimental vaccine into the 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 should be required for 18 to 30 months and the trial should last four years. More information about the study is available at https://www.clinicaltrials.gov/ using the identifier NCT04645147.
NIAID conducts and supports research—at the NIH, in the United States, and around the world—to study the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose, and treat these diseases. Press releases, fact sheets, 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, comprises 27 institutes and centers and is part of the US Department of Health and Human Services. The NIH is the primary 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 the NIH and its programs, visit www.nih.gov.