NIH launches clinical trial of Epstein-Barr virus vaccine
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NIH launches clinical trial of Epstein-Barr virus vaccine
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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 preventive vaccine against Epstein-Barr virus (EBV).
Epstein-Barr virus is the leading cause of infectious mononucleosis (“mono”) and is associated with certain cancers and autoimmune diseases.
The Phase 1 study is one of only two in more than a decade to test an investigational Epstein-Barr virus vaccine. It will take place at the NIH Clinical Center in Bethesda, Maryland.
EBV is a member of the herpesvirus family and is one of the most common human viruses. It is spread through bodily fluids, most notably saliva.
In the United States, there are an estimated 125,000 cases of infectious mononucleosis each year; about 10% of them experience fatigue lasting 6 months or longer.
About 1 percent of people infected with EBV develop serious complications, including hepatitis, neurological problems, or serious blood abnormalities.
EBV is also associated with several malignancies, including gastric and nasopharyngeal cancers, Hodgkin and Burkitt lymphomas, and autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis.
“A vaccine that can prevent or reduce the severity of Epstein-Barr virus infection could reduce the incidence of infectious mononucleosis and possibly Epstein-Barr virus-related malignancies,” said NIAID Director Anthony S. Fauci, MD. and the incidence of autoimmune diseases.”
Led by Jessica Durkee-Shock, MD, principal investigator in the NIAID Infectious Disease Laboratory, the study will evaluate the safety and immune response of an investigational EBV gp350-Ferritin nanoparticle vaccine using a saponin-based Matrix- M adjuvant.
The experimental vaccine was developed by the Infectious Disease Laboratory in collaboration with NIAID’s Center for Vaccine Research. Matrix-M adjuvant was developed by Novavax, a biotechnology company based in Gaithersburg, Maryland.
The vaccine works by targeting the EBV glycoprotein gp350, which is present on the surface of the virus and virus-infected cells. EBV gp350 is also a major target of neutralizing antibodies found in the blood of people naturally infected with EBV.
Ferritin, a natural iron storage protein found in cells of all biological species, is considered a promising vaccine platform because it can display proteins from target viruses densely packed on its surface. Adjuvants are designed to enhance the immune response induced by the investigational vaccine.
The study will enroll 40 healthy adult volunteers between the ages of 18 and 29, half of whom have evidence of prior EBV infection and half without evidence of prior EBV infection.
Participants will be given three injections of 50 micrograms of the experimental vaccine into the muscles of their upper arms, followed by observation for 30 to 60 minutes after each injection.
The second and third doses will be given 30 and 180 days after the initial dose, with follow-up visits between each vaccination and telephone contact between visits. Participation is expected to take 18 to 30 months, and the trial is expected to last four years.
More information about this study is available through the identifier NCT04645147 on ClinicalTrials.gov.
NIH launches clinical trial of Epstein-Barr virus vaccine
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