The phase 1 trial is expected to last four years and enroll 40 participants
TUESDAY, May 10, 2022 (HealthDay News) — The U.S. National Institutes of Health are launching an early-stage clinical trial to evaluate a potential vaccine for Epstein-Barr virus (EBV).
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 Laboratory of Infectious Diseases in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center developed the vaccine, while the Matrix-M adjuvant was developed by the biotechnology company Novavax.
The study plans to enroll 40 healthy adults (aged 18 to 29 years), half with evidence of prior EBV infection and half without evidence of prior EBV infection. In total, participants will receive 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. Follow-up visits will occur between each vaccination and phone calls between visits. The trial will last four years with participation lasting 18 to 30 months.
“A vaccine that could prevent or reduce the severity of infection with the EBV could reduce the incidence of infectious mononucleosis and might also reduce the incidence of EBV-associated malignancies and autoimmune diseases,” Anthony S. Fauci, M.D., director of the NIAID, said in a statement.
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