Bethesda, MD—The Epstein-Barr virus (EBV), in the herpes virus family, is one of the most common human viruses and is spread through bodily fluids, usually saliva. It is the cause of mononucleosis, dreaded by generations of youths as "the kissing disease."

In the United States, about 125,000 cases of infectious mononucleosis occur each year, with approximately 10% of those patients ending up with symptoms of fatigue lasting 6 months or longer. About 1% of those infected with EBV end up with even more serious complications such as hepatitis, neurologic problems, or severe blood abnormalities, according to the National Institutes of Health (NIH).

Also concerning are some malignancies, including stomach and nasopharyngeal cancers, and Hodgkin and Burkitt lymphomas, as well as autoimmune diseases (e.g., systemic lupus erythematosus and multiple sclerosis), that have been associated with EBV infections.

That is why the NIH's NIAID has launched an early-stage clinical trial to evaluate the possibility of a preventative vaccine for EBV. The phase I study, which will be conducted at the NIH Clinical Center in Bethesda, Maryland, is one of only two studies to test an investigational EBV vaccine in more than a decade.

"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," stated NIAID Director Anthony S. Fauci, MD.

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, and the Matrix-M adjuvant was developed by the Gaithersburg, Maryland–based biotechnology company Novavax.

The vaccine is designed to target EBV glycoprotein gp350 on the surface of the virus and virus-infected cells. That glycoprotein is also the primary target for neutralizing antibodies found in the blood of people naturally infected with EBV.

An NIAID press release noted that "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."

The study will include 40 healthy volunteer adults aged up to 29 years, half of whom have evidence of prior EBV infection and the remaining half that do not have evidence of prior EBV infection. They will receive a series of three 50-mcg 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 and phone calls between each vaccination and visits.

Their participation is expected to be required for 18 to 30 months, and the trial is expected to last 4 years. More information about the study can be found here.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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