CMV Vaccines and Clinical Trials
Currently, there is no CMV vaccine available to prevent congenital cytomegalovirus (CMV). CMV vaccines are still in the research and development stage, with the hope and expectation that it will be available in the next 5 to 10 years.
Many experts believe that a CMV vaccine preventing the transmission of CMV to the baby after maternal infection, would greatly reduce long-term disabilities in infants. The rubella vaccine is an example of a comparable vaccine given in childhood to eliminate maternal to child transmission of the virus. The rubella vaccine has eliminated congenital rubella syndrome as a cause of birth defects in countries where the vaccine is administered (eradicated in the United States in 2015), and there is similar hope for a CMV vaccine.
What's critical to moving this forward? Public health demand and financial support from the general population, the pharmaceutical industry, and the federal government.
Potential target populations for the CMV vaccine include women of childbearing age, immunocompromised patients, and children. Due to the high incidence of congenital CMV transmission, CMV vaccines are usually designed for adolescent girls or women of childbearing age to prevent the vertical transmission (passage of a disease-causing agent or pathogen from mother to baby across the placenta, in breast milk, or through direct contact during or after birth) of CMV. In addition, immunocompromised patients, including organ transplant recipients, are a target population since they are at-risk of CMV-related disease.
In the future and to comprehensively prevent the spread of CMV infection, it is highly recommended that the CMV vaccine should be incorporated in the routine childhood vaccination schedule.
CMV Vaccine Trials
Vaccine clinical trials include the following:
- Phase I trials - costs less than $1 million
- Phase II trial - costs $5-$10 million
- Phase III trial - costs $10-$750 million
Multiple global pharmaceutical companies, clinical research organizations, clinical trial companies, and academic research centers are dedicated to the launch of an effective CMV vaccine. For a congenital CMV vaccine specifically, there have been approximately 10 phase I trials, 2 phase II trials, and no phase III trials to date.
In 1999, the National Institute of Medicine (IOM) reviewed 26 conditions with the potential for vaccine prevention and ranked different candidate vaccines from Levels I-IV (highest to lowest) based on cost impact and Quality of Life Adjusted Year (QALY) saved. A congenital CMV vaccine, given to 12-year-olds, was ranked the first priority in the Level I group as a first priority because of cost savings as well as the human suffering that would be alleviated by stopping CMV.
In the early 1990s, the annual cost for caring for children born with congenital CMV was estimated at $1-$2 billion for the U.S. alone. Because children born with congenital CMV often require long-term care and extensive medical and surgical interventions, the average cost per child was estimated at $300,000.
There have been no recent studies to re-evaluate the cost impact of congenital CMV.
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