Pfizer recently announced the initiation of RENOIR (RSV vaccine Efficacy study iNOlder adults Immunised against RSV disease), a phase-III 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 aged 60 years or older.
Speaking in this regard, Kathrin U Jansen, PhD, Senior Vice President and Head, Vaccine Research and Development, Pfizer, said, “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. The start of this phase-III study is an important step forward towards our goal of comprehensive immunisation 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 immunisation, subject to regulatory approval of the candidate vaccine.”
The phase-III RENOIR trial of RSVpreF is a global, randomised, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants aged 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, added the statement.