RSV

Respiratory Syncytial Virus (RSV) has a high prevalence in developed countries, causes respiratory tract infections in patients of all ages, especially in patients with weak immune systems. It is a major cause of lower respiratory tract infection during infancy, and the main cause of pneumonia and bronchiolitis in children under the age of 1, responsible for up to 10% of their intensive care hospitalizations. Infections have also increasingly been found among elderly patients, causing life-threatening pulmonary disease in the elderly, killing half as many or as many elderly and high-risk adults as much as influenza does.

RSV is highly contagious and can be spread through droplets containing the virus when someone coughs or sneezes. It also can live on surfaces (such as countertops or doorknobs) and on hands and clothing, so can be easily spread when a person touches something contaminated

Mymetics’ RSV vaccine approach

There is no vaccine for RSV. In the past, attenuated infectious virus vaccine candidates were found to be either over- or under-attenuated, and the immune response induced by inactivated virus or subunit vaccineswas associated with serious safety risks, sometimes leading to more serious disease in people that were vaccinated and later infected by the virus, than non-vaccinated people (“enhanced disease”). Mymetics has developed an RSV vaccine for the elderly population, representing a target population in the Western world of about 150 million. It is a virosome based RSV vaccine which has gone through extensive pre-clinical testing.

Latest Results and Next Steps

The safety in animal models was proven and Mymetics showed that the vaccine did not induce enhanced disease, while mice and cotton rats were completely protected against a live virus challenge.

The next stage for Mymetics will be the production and preparation for a human clinical phase I trial, in which the safety and tolerance will be tested in human patients. If the vaccine is found to be safe and well tolerated, a larger Phase II clinical trial will follow to assess efficacy. Criteria for efficacy will be set based on elevation of the levels of circulating neutralizing antibody in a group of elderly people. If the vaccine successfully passes this test, a Phase III trial will follow in which a large group of elderly people will be vaccinated, and their protection against seasonal RSV infection will be assessed.