Janssen Announces Start of Phase 3 Trial for Investigational Respiratory Syncytial Virus (RSV) Vaccine in Older Adults
RARITAN, N.J., September 29, 2021 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the initiation of its Phase 3 EVERGREEN study. The study will evaluate the efficacy, safety and immunogenicity of Janssen's investigational adult vaccine against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV), when compared with placebo in approximately 23,000 adults aged 60 years and older throughout North America and a selection of countries across Europe, Asia and the Southern Hemisphere.
The EVERGREEN study was initiated based on positive results from the Phase 2b CYPRESS study, the first large study evaluating the efficacy and safety of Janssen's investigational RSV vaccine against RSV-associated LRTD in vaccinated adults aged 65 and older in the United States.
Efficacy and immunogenicity data from the Phase 2b CYPRESS study will be presented at the virtual IDWeek 2021 taking place from September 29 - October 3 (Abstract #1106286).
"Positive data from our first RSV vaccine efficacy study and the initiation of the Phase 3 EVERGREEN study are crucial milestones in the clinical development of our investigational RSV adult vaccine, which has the potential to safely and effectively prevent lower respiratory tract disease caused by RSV in older adults," says Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. "With no vaccine or broadly-indicated antiviral treatment available, preventive solutions to address the significant morbidity and mortality in older adults caused by RSV have long been an unmet need."