Today News: Phase 2b CYPRESS study met all primary and secondary endpoints

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that its investigational respiratory syncytial virus (RSV) vaccine candidate was highly effective in protecting against lower respiratory tract disease (LRTD) caused by RSV, demonstrating vaccine efficacy of 80 percent (CI, 52.2-92.9%) in adults aged 65 and older. The study results were presented as a late-breaking abstract at the virtual IDWeek 2021 conference on October 2.

“The findings from our CYPRESS study are very encouraging as we seek to deliver a long-awaited preventive vaccine to stave off the severe complications associated with RSV in adults,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “Respiratory syncytial virus is a leading cause of bronchitis and pneumonia and one of the most common infections in the world. As older adults are at high risk of developing serious, potentially life-threatening illness from RSV, there is an urgent need for a vaccine to prevent the significant morbidity and mortality caused by the virus.”

The CYPRESS study met its primary and secondary endpoints, with the investigational RSV adult vaccine demonstrating efficacy of 80 percent (CI, 52.2-92.9%) against confirmed RSV-associated LRTD. The investigational RSV adult vaccine also demonstrated efficacy of 70 percent (CI, 42.7-85.1%) against any symptomatic RSV-associated acute respiratory infection (ARI).

The investigational RSV adult vaccine candidate elicited robust humoral and cellular immune responses in adults aged 65 and older, with participants in the immunogenicity subset showing a substantial increase in RSV neutralizing antibodies 14 days after vaccination. The investigational RSV vaccine candidate was generally well-tolerated in all vaccinated participants.

“RSV remains a major global public health concern and a cause of serious respiratory illness in all age groups,” said Ann R. Falsey, M.D., Professor of Medicine, University of Rochester School of Medicine and presenting author*. “The positive efficacy results from the CYPRESS study reinforce the potential of this investigational RSV vaccine in preventing serious disease resulting from RSV in older adults.”

Following an initial proof-of-concept study with Janssen’s investigational RSV adult vaccine (Ad26.RSV.preF component only) in a human challenge study,1 Janssen combined Ad26.RSV.preF with a prefusion F (preF) protein for induction of a more optimal immune response. This combination single-dose regimen was evaluated in the Phase 2b CYPRESS study, which enrolled 5,782 participants across 40 sites in the United States followed through a single RSV season.

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