Moderna CMVictory phase 3 vaccine trial

CMV is the most common congenital (present at birth) viral infection in the United States and one of the most common infectious causes of birth defects globally. Children born with congenital CMV infection are at risk of developing lifelong complications in the nervous system, such as hearing loss and developmental delays. There is an unmet need for safe and effective CMV prevention. 

• This Phase 3 clinical trial is designed to evaluate an investigational vaccine (mRNA-1647) for its safety and effectiveness in preventing CMV in healthy adult females. 
• This vaccine uses a new technology called messenger ribonucleic acid (mRNA). Traditionally, vaccines against viruses were administered by injecting certain antigens into the body to create an immune system response as if someone was naturally exposed to the virus. Now we can use the information molecule mRNA in vaccines. mRNA vaccines can tell the body to produce the antigen to create the same immune system response against the virus. The investigational vaccine will be given in the usual manner, as an injection into the upper arm. 
• For this Phase 3 trial, healthy women (ages 16-40) will be randomly assigned 50% to 50% (like flipping a coin) to receive either the investigational vaccine or a placebo 3 times over a 6-month period: at Day 1, Month 2, and Month 6. They then will be monitored over the following 24 months. 
• Participation is expected to last for approximately 30 months.

For more information on CMV please visit the CMV Action website or Contact Lakeside Research

Published: May 10, 2023