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Moderna today announced that the RSV Program’s Data and Safety Monitoring Board (DSMB) has approved the initiation of a pivotal Phase 3 clinical study (ConquerRSV) of mRNA-1345 in the elderly population 60 years and older
.
mRNA-1345 is an investigational respiratory syncytial virus (RSV) vaccine
The approval of the DSMB follows an independent review of preliminary Phase 2 clinical trial data
.
These data demonstrate that, at selected doses, mRNA-1345 has an acceptable safety profile in the elderly population
RSV is a common respiratory virus that usually causes cold-like symptoms
.
While most people infected with RSV recover in about 1-2 weeks, the virus can be serious in young children and the elderly
The burden of disease caused by RSV is enormous; each year in the United States, RSV causes approximately 177,000 hospitalizations, 14,000 deaths in adults 65 and older, and an estimated $3 billion in annual healthcare costs
.
RSV is generally a seasonal disease, with infection primarily occurring in the fall, winter, and spring in the United States and countries with similar climates
.
However, in 2021, the COVID-19 pandemic has affected the normal transmission pattern of RSV, resulting in unusual infection levels
mRNA-1345, a vaccine against RSV, encodes a prefusion F glycoprotein that induces higher neutralizing antibody responses compared to the postfusion state
.
mRNA-1345 uses the same lipid nanoparticles (LNPs) as Moderna's COVID-19 mRNA vaccine and contains optimized protein and codon sequences
The primary objective of the pivotal Phase 3 clinical study ConquerRSV is to determine the safety and efficacy of the mRNA-1345 vaccine in adults over the age of 60 to support the marketing application
.
Moderna expects to enroll 34,000 participants