CMVictory mRNA-1647 Phase 3

The mRNA-1647-P301 Phase 3 trial is a global, multi-center, randomized, observer-blind, placebo-controlled Phase 3 study to evaluate the efficacy, safety and immunogenicity of the mRNA-1647 cytomegalovirus vaccine in healthy female participants aged 16-40 years.

Cytomegalovirus (CMV) is a leading cause of birth defects worldwide. CMV is a common viral infection that usually goes unnoticed or causes only mild symptoms in most people. But if a woman becomes infected with CMV while pregnant, she can pass the infection to her unborn baby. This can result in long-term disability due to birth defects, including hearing loss, or even death in very severe cases. There is currently no licensed vaccine for CMV.

This vaccine trial, sponsored by ModernaTX, Inc.®, is being conducted at the Bernhard Nocht Centre for Clinical Trials ( BNCCT ) in collaboration with the Bernhard Nocht Institute for Tropical Medicine ( BNITM ).
The study will enroll a total of 7,300 participants at approximately 230 sites worldwide, including 6,900 CMV-seronegative female participants. The primary efficacy objective is to demonstrate vaccine efficacy of mRNA-1647 against primary CMV infection in female participants who are CMV seronegative at enrollment. Primary CMV infection is defined as seroconversion from negative to positive for serum immunoglobin G (IgG) to CMV, assessed beginning 28 days after the third injection.

CMVictory (Link to german website)

Clinical trial NCT05085366