NIH Starts Clinical Trial of Epstein-Barr Vaccine

NIAID launched an early-stage clinical trial to evaluate an investigational preventative vaccine for 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 Clinical Center, is 1 of only 2 studies to test an investigational 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 is spread through bodily fluids, primarily saliva. Of those who contract infectious mononucleosis, roughly 10 percent develop fatigue lasting 6 months or longer. 

Approximately 1 percent 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 study will evaluate the safety and immune response of an experimental vaccine developed by NIAID’s Laboratory of Infectious Diseases in collaboration with its Vaccine Research Center. The adjuvant—intended to enhance the immune response induced by the investigational vaccine—was developed by the biotechnology company Novavax, based in Gaithersburg, Md.

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 neutralizing antibodies found in the blood of people naturally infected with EBV. 

The study will enroll 40 healthy volunteers ages 18 to 29, half of whom have evidence of prior EBV infection. More information about the study is available at: www.clinicaltrials.gov/. Use the identifier NCT04645147.