Epstein-Barr Virus Vaccine May Soon Enter Phase 3 Trial

Lara C. Pullen, PhD

November 07, 2011

November 7, 2011 — An Epstein-Barr virus (EBV) vaccine in the early phases of development may prove able to prevent infectious mononucleosis and EBV-associated cancers, without necessarily preventing the EBV infection itself. The vaccine targets the EBV glycoprotein gp350, which is the most abundant glycoprotein on the virus and on virus-infected cells.

Success in the phase 2 gp350 vaccine trial has led to the recommendation that a phase 3 trial of the EBV vaccine be designed and conducted. Other vaccines are also under development to treat EBV-associated malignancies.

This recommendation is described in an article from the National Institutes of Health, published in the November issue of Science Translational Medicine. In the article, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), and Harold Varmus, MD, director of the National Cancer Institute, join Gary Nabel, MD, PhD, director of NIAID's Vaccine Research Center, and Jeffrey Cohen, MD, chief of NIAID's Laboratory of Infectious Diseases, to summarize a recent meeting of experts who gathered to map directions toward an EBV vaccine. The meeting was held at the National Institutes of Health on February 1, 2011, and included scientists from government, academia, and industry.

The scientists noted that EBV infects only humans, and that the lack of a convenient animal model has challenged EBV vaccine research. They therefore called for the identification of surrogate markers that predict the development of EBV-related malignancies and biomarkers that can be used for screening for early-stage EBV-related malignancies. The identification of these biological "surrogate" markers would facilitate EBV vaccine development. The experts also called for further research to determine which immune system response to vaccination best correlated with protection from infection or disease.

EBV infects more than 90% of the human population and is associated with several human cancers including Burkitt lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, and nasopharyngeal carcinoma. Infections in early childhood often cause no disease symptoms, but people infected during adolescence or young adulthood may develop infectious mononucleosis, which is characterized by swollen lymph nodes, fever, and severe fatigue. EBV-associated lymphomas occur in 1% to 20% of recipients of bone marrow and organ transplants. Prevention of these diseases through EBV vaccination would have a substantial public health and economic effect.

The National Institutes of Health meeting held in February 2011 was sponsored by the National Cancer Institute and by the Vaccine Research Center, an intramural research program of the National Institute of Allergy and Infectious Diseases.

Sci Transl Med. 2011;3:107fs7. Abstract

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