Vaccine against Epstein-Barr virus may enter clinical trial next year

German startup plans to test EBV-001 in preventing mononucleosis, MS risk factor

Andrea Lobo, PhD avatar

by Andrea Lobo, PhD |

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EBViously announced that it has developed a candidate vaccine against the Epstein-Barr virus and plans to bring it into clinical trials starting in 2024.

The company is a spinoff of Helmholtz Munich, part of a German government research network. It is led by scientists with expertise in EBV research working toward a safe and effective vaccine against the virus and the various diseases associated with EBV infection, including multiple sclerosis (MS).

A first clinical trial of the potential vaccine, called EBV-001, will aim to prevent mononucleosis, or mono, and the chronic fatigue it can cause. Mononucleosis due to EBV infection has been linked with a higher risk of MS, and Epstein-Barr is strongly considered a potential factor in disease development.

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“As a primary indication, we are targeting the prevention of infectious mononucleosis, also known as kissing disease,” Wolfgang Hammerschmidt, chief scientific officer of EBViously, said in a press release from the German Center for Infection Research, which supported the EBV project.

“As infectious mononucleosis is a known risk factor for multiple sclerosis, there is great hope that our vaccine may also reduce the incidence of this chronic neurodegenerative autoimmune disease,” Hammerschmidt added.

Other possible trials of the EBV-001 vaccine are planned for people with post-transplant lymphoproliferative disease, a potentially life-threatening complication of organ transplants, and EBV-related cancers.

A member of the herpes virus family, EBV is estimated to infect up to 95% of the world’s population. Infections usually go unnoticed and without symptoms, particularly in children. But they can be serious in teenagers and adults who develop infectious mononucleosis, marked by fever, headache and swollen lymph nodes.

After infection, EBV remains dormant inside B-cells, part of the immune system. It is believed to make these cells overactive, raising the risk of diseases like MS and certain B-cell cancers, including various lymphomas.

A study following more than 10 million adults in the U.S. for 20 years showed that previous EBV infection increased a person’s risk of multiple sclerosis by 32 times. Their association may be related to similarities in given viral and brain proteins, meaning that an immune response targeting the virus may also attack brain tissue, a separate study reported.

The vaccine candidate is based on virus-like particles that are similar to the virus but do not cause an infection. Specifically, these particles are composed of the virus shell and do not contain any viral genetic material.

The shell contains more than 50 viral antigens, molecules that mimic EBV to trigger a highly specific immune response against the virus.

Preclinical testing showed that EBV-001 can elicit an immune response, EBViously reported. In animal models, the vaccine was able to induce a broad immune response reflecting human immunity against the virus.

“Based on our very favorable preclinical proof-of-concept data regarding the immunogenicity of the vaccine, we are confident that EBV-001 can effectively prevent the development of infectious mononucleosis and the often associated chronic fatigue syndrome,” said Axel Polack, MD, the company’s CEO.

Good manufacturing practices, which ensure that a treatment is consistently produced according to quality standards, are in place, Polack said. These practices are required to request a start of clinical testing.