Cytomegalovirus vaccine

A Cytomegalovirus vaccine is a vaccine to prevent cytomegalovirus (CMV) infection or to prevent it re-activation in those who are already infected. Challenges in developing a vaccine include adeptness of CMV in evading the immune system and limited animal models. As of 2018 no such vaccine exists, although a number of vaccine candidates are under investigation. They include recombinant protein, live attenuated, DNA and other vaccines. A Cytomegalovirus vaccine is a vaccine to prevent cytomegalovirus (CMV) infection or to prevent it re-activation in those who are already infected. Challenges in developing a vaccine include adeptness of CMV in evading the immune system and limited animal models. As of 2018 no such vaccine exists, although a number of vaccine candidates are under investigation. They include recombinant protein, live attenuated, DNA and other vaccines. As a member of the TORCH complex, cytomegalovirus can cause congenital infection, which can lead to neurological problems, vision and hearing loss. Infection/re-activation of CMV in immuno-compromised persons, including organ transplantation recipients, causes significant mortality and morbidity. Additionally, CMV has strong associations with plaques found in atherosclerosis progression. Because of all these, there has been considerable effort made towards the development of a vaccine, with particular emphasis on protection of pregnant women. Since vaccination of the immunocompromised persons introduces additional challenges, members of this population are less likely to be candidates for such a vaccine. Additionally, there are additional health risks for individuals who are already not infected with CMV. For instance, CMV infection is strongly associated with development of Alzheimer's Disease. Development of such a vaccine has been emphasized as a priority by the National Vaccine Program Office in the United States. A phase 2 study of a recombinant gB subunit CMV-vaccine published in 2009 indicated an efficacy of 50% in seronegative women of childbearing age—thus the protection provided was limited and a number of subjects contracted CMV infection despite the vaccination. In one case congenital CMV was encountered. Another phase 2 study of the same vaccine was done in patients awaiting kidney transplantation. The vaccine significantly boosted the antibody levels and reduced the duration of post-transplantation viremia. In 2013, Astellas Pharma has started on individuals who received a hematopoietic stem cell transplant a Phase III trial with its CMV deoxyribonucleic acid DNA cytomegalovirus vaccine ASP0113. In 2015, Astellas Pharma has commenced on healthy volunteers a Phase I trial with its cytomegalovirus vaccine ASP0113. In 2016, VBI Vaccines commenced a Phase I preventative cytomegalovirus vaccine study (VBI-1501).