A Cytomegalovirus vaccine is a
vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifi ...
to prevent
cytomegalovirus
''Cytomegalovirus'' (CMV) (from ''cyto-'' 'cell' via Greek - 'container' + 'big, megalo-' + -''virus'' via Latin 'poison') is a genus of viruses in the order '' Herpesvirales'', in the family '' Herpesviridae'', in the subfamily '' Betaherp ...
(CMV) infection or curb virus re-activation (symptomatic flare-ups) in persons 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
Organ transplantation is a medical procedure in which an organ is removed from one body and placed in the body of a recipient, to replace a damaged or missing organ. The donor and recipient may be at the same location, or organs may be trans ...
recipients, causes significant
mortality and
morbidity
A disease is a particular abnormal condition that adversely affects the structure or function of all or part of an organism and is not immediately due to any external injury. Diseases are often known to be medical conditions that are asso ...
. Additionally, CMV is implicated in the pathogenesis of various chronic conditions including
atherosclerosis
Atherosclerosis is a pattern of the disease arteriosclerosis, characterized by development of abnormalities called lesions in walls of arteries. This is a chronic inflammatory disease involving many different cell types and is driven by eleva ...
and
coronary artery disease
Coronary artery disease (CAD), also called coronary heart disease (CHD), or ischemic heart disease (IHD), is a type of cardiovascular disease, heart disease involving Ischemia, the reduction of blood flow to the cardiac muscle due to a build-up ...
with recent studies indicating a potential link to increased risk of Alzheimer's disease. Therefore naturally there has been considerable effort made towards the development of a CMV vaccine, with particular emphasis on protection of pregnant women.
Development of such a vaccine has been emphasized as a priority by the
National Vaccine Program Office The National Vaccine Program Office (NVPO) is an office of the United States Department of Health and Human Services
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the US fed ...
in the United States.
Since vaccination of the immunocompromised persons introduces additional challenges, members of this population are less likely to be candidates for such a vaccine.
Recombinant gB subunit vaccine
A
phase 2 study of a recombinant
gB protein subunit CMV-vaccine "gB/MF59" was published in 2009 and 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
Kidney transplant or renal transplant is the organ transplant of a kidney into a patient with end-stage kidney disease (ESRD). Kidney transplant is typically classified as deceased-donor (formerly known as cadaveric) or living-donor transplantat ...
. The vaccine significantly boosted the antibody levels and reduced the duration of post-transplantation viremia.
Further research
In 2013, Astellas Pharma has started on individuals who received a hematopoietic stem cell
Hematopoietic stem cells (HSCs) are the stem cells that give rise to other blood cells. This process is called haematopoiesis. In vertebrates, the first definitive HSCs arise from the ventral endothelial wall of the embryonic aorta within the ...
transplant a Phase III trial with its CMV deoxyribonucleic acid DNA
Deoxyribonucleic acid (; DNA) is a polymer composed of two polynucleotide chains that coil around each other to form a double helix. The polymer carries genetic instructions for the development, functioning, growth and reproduction of al ...
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).
Other cytomegalovirus vaccines candidates are the CMV-MVA Triplex vaccine and the CMVpp65-A*0201 peptide vaccine. Both vaccine candidates are sponsored by the City of Hope National Medical Center
City of Hope is a private, non-profit clinical research center, hospital and graduate school located in Duarte, California, United States. The center's main campus resides on of land adjacent to the boundaries of Duarte and Irwindale, California ...
. As of 2016, the development is in clinical phase 2 trial stage.
In March 2019, Helocyte and City of Hope National Medical Center announced positive phase two results for Triplex. They are working on finding funding for Phase III research and then FDA approval.
Moderna Moderna, Inc. ( ) is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts, that focuses on RNA therapeutics, primarily mRNA vaccines. These vaccines use a copy of a molecule called messenger RNA (mRNA) to carry inst ...
is working on mRNA-1647, a mRNA CMV vaccine. It was the first mRNA vaccine to enter phase 2 clinical trials.
References
{{Vaccines
Vaccines