The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has initiated an early-stage clinical trial to evaluate an experimental preventive Epstein-Barr virus (EBV) vaccine. EBV is the leading cause of infectious mononucleosis and is associated with certain types of cancer and autoimmune diseases. The Phase 1 trial, being conducted at the NIH Clinical Center in Bethesda, Maryland, is one of only two trials that have tested an experimental EBV vaccine in more than a decade.
EBV is a member of the herpesvirus family and one of the most common human viruses. It is transmitted through body fluids, mainly saliva. An estimated 125,000 cases of infectious mononucleosis occur in the United States each year; 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 cancer and Hodgkin and Burkitt lymphoma, 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-related malignancies and autoimmune diseases. »
Anthony S. Fauci, MD, Director of NIAID
Led by study leader Jessica Durkee-Shock, MD, of the NIAID Infectious Diseases Laboratory, the study will evaluate the safety and immune response of an investigational EBV-gp350 ferritin nanoparticle vaccine with a saponin-based Matrix-M adjuvant. The experimental vaccine was developed by the Infectious Diseases Laboratory in collaboration with NIAID’s Vaccine Research Center. Matrix-M adjuvant was developed by 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 primary 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 of its ability to present the proteins of the target virus in a dense network on its surface. The adjuvant is intended to enhance the immune response induced by the experimental vaccine.
The study will enroll 40 healthy adult volunteers between the ages of 18 and 29, half of whom will have evidence of previous EBV infection and half will not. Participants will receive a series of three injections of 50 micrograms of the experimental vaccine into the muscle of the upper arm, followed by observation for 30 to 60 minutes after each dose. The second and third doses are 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 study should last four years. Additional information on the study is available at ClinicalTrials.gov under identifier NCT04645147.
NIH/National Institute of Allergy and Infectious Diseases