Pfizer Inc. today announced the initiation of RENOIR, a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) bivalent prefusion F subunit investigational vaccine candidate (RSVpreF) in adults ages 60 years or older.
“RSV is a significant cause of severe respiratory disease in older adults, and it can cause disability and death. There is an important unmet medical need for an effective vaccine that can help protect older adults against this highly-contagious disease,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc. “The start of this Phase 3 study is an important step forward towards our goal of comprehensive immunization against RSV disease, which includes developing a potential first vaccine to help prevent RSV disease in adults as well as the ongoing efforts to help protect infants through maternal immunization, subject to regulatory approval of the candidate vaccine.”
The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. The primary objectives of the study will assess safety and efficacy for the prevention of moderate to severe lower respiratory tract illness (msLRTI-RSV) during the first RSV season.
RSV is a seasonal illness that commonly starts in the fall months, peaking in the winter, when colds and other respiratory illnesses are more common.
Burden of RSV
Respiratory syncytial virus (RSV) is a common and pervasive cause of acute respiratory illness. The virus is highly contagious and affects the lungs and airways. Infections occur in people of all ages and can feel like the common cold for most young adults, but for infants, the immunocompromized, and older adults, it can be potentially life-threatening.
The risk of serious infection increases in older adults and for those with chronic heart or lung disease or a weakened immune system. In the U.S., it is estimated that more than 177,000 older adults ≥65 years of age are hospitalized and 14,000 of them die each year due to RSV. There is no vaccine to prevent RSV and the medical community is limited to offering only supportive care for those with the illness.