The National Institute of Allergy and Infectious Diseases (NIAID), a joint venture of the National Institutes of Health, has launched an early-stage clinical investigation to evaluate an investigational preventative vaccine for the Epstein-Barr virus (EBV). EBV is the primary 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
EBV is a member of the herpes virus family and is spread through bodily fluids, mostly saliva. Each year, an estimated 125,000 instances of infectious mononucleosis are reported in the United States, with approximately 10% of those diagnosed with fatigue lasting six months or longer. EBV is also associated with several malignancies, including systemic lupus erythematosus and multiple sclerosis.
According to NIAID Director Anthony S. Fauci, a vaccine that might prevent or reduce the severity of infection with the Epstein-Barr virus might reduce the incidence of infectious mononucleosis, and may also reduce the incidence of EBV-associated malignancies and autoimmune diseases.
The study will investigate the safety and immune response of an EBV gp350-Ferritin nanoparticle vaccine with a saponin-based Matrix-M adjuvant, led by principal investigator Jessica Durkee-Shock, of the NIAIDs Laboratory of Infectious Diseases. Novavax, a biotechnology company with a headquarters in Gaithersburg, Maryland.
The vaccine is aimed at boosting immune responses induced by the investigational vaccine by targeting EBV glycoprotein gp350, which is found on the surface of the virus and virus-infected cells. EBV gp350, a natural iron storage protein found in all living organisms, is also considered a promising vaccine platform. Ferritin, a natural iron storage protein found on all living organisms, is considered a promising platform because it can display proteins from the targeted virus in a broad array on its
The study will target 40 healthy volunteer adults aged 18 to 29 years, half of whom have evidence of prior EBV infection, and half of whom do not have evidence of prior EBV infection. During the first week of the study, participants will receive three 50-microgram injections in the upper arm muscle, followed by 30 to 60 minutes of observation after each dose. The second and third doses will be administered 30 days and 180 days after the initial dose, according to the identifierNCT04645147.