NIH launches clinical trial of Epstein-Barr virus vaccine

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has launched an early-stage clinical trial to evaluate an investigational preventative vaccine for Epstein-Barr virus (EBV), the primary cause of infectious mononucleosis that is associated with certain cancers and autoimmune diseases. The phase-I study, which will be conducted at the NIH Clinical Centre in Bethesda, Maryland, is one of only two studies to test an investigational EBV vaccine in more than a decade, NIH said in a statement.

The vaccine works by targeting EBV glycoprotein gp350, which is found on the surface of the virus and virus-infected cells. EBV gp350 is also the primary target for neutralising antibodies found 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 proteins from the targetted virus in a dense array on its surface. The adjuvant is intended to enhance the immune response induced by the investigational vaccine, the statement mentioned.

“A vaccine that could prevent or reduce the severity of infection with the Epstein-Barr virus could reduce the incidence of infectious mononucleosis and might also reduce the incidence of EBV-associated malignancies and autoimmune diseases,” said Anthony S Fauci, MD, Director, NIAID, in the statement.

Led by principal investigator Jessica Durkee-Shock, MD, Laboratory of Infectious Diseases, NIAID, 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 Laboratory of Infectious Diseases in collaboration with NIAID’s Vaccine Research Centre. The Matrix-M adjuvant was developed by the biotechnology company Novavax, based in Gaithersburg, Maryland, added the statement.

The study will enroll 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. Participants will be given a series of three 50-microgram injections of the experimental vaccine 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, with follow-up visits between each vaccination and phone calls between visits. Participation is expected to be required for 18 to 30 months, and the trial is expected to last four years, the statement concluded.