The National Institute of Allergy and Infectious Diseases (NIAID) has launched a clinical trial to evaluate an investigational preventative vaccine for Epstein-Barr virus (EBV). Part of the National Institutes of Health, NIAID will conduct a Phase 1 study at the NIH Clinical Center in Bethesda, Maryland to evaluate the safety and immune response of the investigational vaccine gp350-Ferritin.
The trial is one of only two studies to test an investigational EBV vaccine in more than a decade.
EBV is the primary cause of infectious mononucleosis and is associated with certain cancers and autoimmune diseases. It is a member of the herpes virus family and one of the most common human viruses. It is spread through bodily fluids, primarily saliva. An estimated 125,000 cases of infectious mononucleosis occur each year in the United States; roughly 10% of those persons develop fatigue lasting six months or longer.
Approximately 1% of all EBV-infected individuals develop serious complications, including hepatitis, neurologic problems, or severe blood abnormalities. EBV also is associated with several malignancies, including stomach and nasopharyngeal cancers and Hodgkin and Burkitt lymphomas, as well as autoimmune diseases, such as systemic lupus erythematosus and multiple sclerosis.
The clinical trial will enrol 40 healthy volunteers, half of whom will have been expected to have had a prior EBV infection. Participants will be given three 50- microgram injections of the experimental vaccine, 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 gp350-Ferritin nanoparticle vaccine will be delivered using a saponin-based Matrix-M adjuvant developed by the biotechnology company Novavax.
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 targeted virus in a dense array on its surface. The adjuvant is intended to enhance the immune response induced by the investigational vaccine.
“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 NIAID Director Anthony S. Fauci.