Epstein-Barr Virus Vaccine
History and Background
The University of Minnesota first began negotiations with the biotechnology company MedImmune in 2012 to obtain EBV vaccine. A clinical trial collaboration and licensing agreement was completed in January 2017 and materials to produce the vaccine were sent to us in May 2017. The Epstein-Barr virus vaccine in development has been in the works since the early 1990s. An EBV vaccine could potentially prevent infectious mononucleosis, EBV-associated cancers, and multiple sclerosis (MS). A vaccine could also potentially prevent severe illness or even death from EBV infection following transplantation, especially in pediatric patients who have not been exposed to the virus and have no immunity to it.
Glycoprotein 350 (gp350), an EBV surface sugar protein, is the basis for this vaccine. The prophylactic vaccine will prevent individuals from becoming infected with EBV. The vaccine will work by introducing this gp350 protein to an individual whose immune system will subsequently produce antibodies against gp350.
How Does the Vaccine Prevent Infection?
In an unimmunized individual, gp350 has the ability to bind to CD21 receptors on the surface of the B cell and cause viral entry and take over of the cell, leading to infection. Individuals who are vaccinated and have antibodies against gp350 will attack gp350 on the surface of EBV and prevent the virus from binding to the B cells, preventing infection.
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Our vaccine development program has reached a major milestone with the transfer of our gp350 material from Molecular Cellular Therapeutics Laboratory to C3 Cell Culture Company. The preparation of biologics is considered a two step process with the upstream portion in this case being the generation of cell culture supernatant that contains the desired product but is impure and the downstream process which is the purification of desired material so it is suitable for clinical trials.
We have made substantial progress in vaccine development in two areas. Mice vaccine experiments, which are on going, have shown that the vaccine produces good antibody responses and protects the mice from a challenge viral infection. We have also confirmed that gp350 raw material appears to be structurally correct and is ready to be sent to a commercial collaborator for purification.
Dr. Sara Hamilton Hart PhD has been immunizing mice with similar material that will be used in the EBV vaccine. Results from her experiments have indicated that gp350 in combination with adjuvant has been able to protect mice from challenge with a live EBV construct.
Researchers have obtained a library of gp350 monoclonal antibodies, which will help verify the structure and quantity of the gp350 antibody being produced in the Molecular and Cellular Therapeutics Laboratory at the University of Minnesota.
The University of Minnesota Molecular and Cellular Therapeutics Laboratory has begun production of the vaccine glycoprotein gp350. Our Clinical Virology Research Lab will start preclinical testing on the material the week of October 2, 2017.
Experiments initiated in mice using gp350 with GLA/SE, the immune adjuvant selected for the human trials. The mouse studies are designed to explore the best vaccination doses and schedules.
Conference call held to discuss details of gp350 (the EBV component of the vaccine) production by the MCB.
The master cell bank (MCB) that produces EBV vaccine arrives at the University of Minnesota.
Agreement signed by both parties.
Term Sheet advances to "Clinical Trial Collaboration and License Agreement."
University of Minnesota Clinical Virology lab begins development of antibody assays to measure the immune response to EBV vaccine.
The first Term Sheet outlining conditions for transfer of vaccine materials is written.
MedI finally agrees to negotiate with the University of Minnesota.
Astra-Zeneca (MedI's parent company) halts EBV vaccine development. Balfour begins discussions to bring EBV vaccine to the University of Minnesota.
MedI site visits University of Minnesota and chooses us to be a clinical site for Phase 1 EBV vaccine trial planned to begin in 2012.
MedI funds two University of Minnesota research projects focused on EBV vaccine epidemiology.
MedIummune, LLC (MedI), had worked intermittently on EBV vaccine since the 1990s. When they learned of our interest, Balfour was invited to present a seminar at MedI. Evidently, they liked what they heard and offered to collaborate with the University of Minnesota.
Drs. David McKenna and Henry Balfour meet periodically to discuss development of an EBV vaccine at the University of Minnesota.
Impact of EBV
280,000 cases of mono in U.S college freshmen annually
200,000 new cases of EBV-associated cancers annually worldwide
2.3 million cases of multiple sclerosis worldwide