Free breaking news alerts from StreetInsider.com!
Johnson & Johnson's Janssen Pharmaceuticals today announced additional vaccine efficacy and safety data from its Phase 2b study of the CYPRESS adult vaccine candidate for respiratory syncytial virus (RSV). The results show that the candidate vaccine is very effective in preventing the three clinical definitions of lower respiratory tract disease (LRTD) caused by RSV, proving that the vaccine is 70% to 80% effective in adults 65 years and older. These data have been announced at the 8th European Influenza Scientific Working Group (ESWI) meeting held on a virtual basis from December 4 to 7, 2021.
"Data from the CYPRESS Phase 2b study brings us closer to providing a potentially first-class vaccine to help protect the elderly from RSV infection," said Penny Heaton, MD, head of the global therapeutic area for vaccines developed by Janssen, LLC. "Because there are no approved vaccines or widely applicable antiviral drugs, the elderly are prone to serious and potentially life-threatening diseases due to RSV. We have now shown a powerful effect on a series of severe lower respiratory diseases, and We believe that our vaccine has the potential to prevent the significant morbidity and mortality caused by RSV every year."
"RSV activity was unusually high last summer, which shows that as the COVID-19 pandemic slows, seasonal respiratory viruses will definitely make a comeback," said Ann R. Falsey, MD, professor of medicine at the University of Rochester School of Medicine and report author*. “Increasingly, RSV is becoming a major global public health problem. These latest data from the CYPRESS Phase 2b study make us even more hopeful that this RSV vaccine candidate may play a key role in protecting vulnerable populations around the world.”
After conducting a preliminary proof-of-concept study on Janssen’s adult RSV vaccine candidate (Ad26.RSV.preF components only) in a human challenge study, 1 Janssen combined Ad26.RSV.preF with the pre-fusion F (preF) protein to induce more changes. Good immune response. This combined single-dose regimen was evaluated in the CYPRESS Phase 2b study, which enrolled 5,782 participants in 40 locations in the United States. Participants were randomized to receive Ad26.RSV.preF or placebo (n = 2891 per group), and were followed up in one RSV season.
The CYPRESS Phase 2b study meets all endpoints. The primary endpoint of the CYPRESS study is the first occurrence of LRTD caused by RSV during the first RSV season after vaccination, according to any of the following three case definitions: (1) ≥ 3 types Lower respiratory tract infection symptoms (LRTI); (2) ≥ 2 LRTI symptoms; (3) ≥ 2 LRTI symptoms or ≥ 1 LRTI symptom with ≥ 1 systemic symptom. The vaccine efficacy of LRTD case definitions 1, 2 and 3 are 80% (CI, 52.2-92.9%), 75% (CI, 50.1-88.5%) and 70% (CI, 43.7-84.7%), respectively. The effectiveness of the first appearance of any symptomatic RSV-related acute respiratory infection (ARI) is 70% (CI, 42.7-85.1%).
Similarly, RSV-specific patient-reported result data from the CYPRESS trial found that RSV-related ARI participants in the vaccine group had milder RSV symptoms compared to the placebo group. Compared with participants in the placebo group, participants who had experienced RSV-related ARI vaccination had milder symptoms and a faster return to normal.
Janssen’s adult RSV vaccine candidate proved to be generally well tolerated. Unsolicited adverse events (AE; fatigue, headache, nausea, myalgia, Fever, injection site reaction) and unsolicited AEs were 29 in the safe subset of 695 participants (vaccine, n=348; placebo, n=347). Severe AEs (SAEs) from all participants were collected before the end of the RSV season (primary endpoint) or 6 months after vaccination (whichever occurs later). In the vaccine group, the most common systemic AEs were fatigue, myalgia, and headache, and the most common local AEs were pain/tenderness. These events are usually mild to moderate in severity, short in duration, and subside within a few days after vaccination. The incidence of active AEs was similar in the two groups (vaccine, 16.7%; placebo, 14.4%); in the entire study population, the incidence of SAE between the groups was similar (vaccine, 4.6%; placebo, 4.7%), and there was no finding Related to vaccines.
Based on the positive results of the CYPRESS Phase 2b study, the Phase 3 EVERGREEN study of Janssen’s RSV adult vaccine candidate is already underway. This is the first large-scale study to evaluate Janssen’s RSV vaccine candidate at the age of 65 and in the United States, Janssen initiated The third global EVERGREEN study was published. The Phase 3 study will evaluate the effectiveness, safety and immunogenicity of the Janssen adult vaccine candidate against LRTD caused by RSV. Compared with placebo, approximately 23,000 60-year-old and The comparison was made among the above adults. Southern Hemisphere.
In September 2019, the US Food and Drug Administration granted Janssen a breakthrough therapy designation for RSV adult vaccine candidate for the prevention of LRTD caused by RSV in adults 60 years of age or older. This is based on clinical data that shows the potential for significant improvement in clinically meaningful endpoints compared to the available standards of care. In November 2020, the European Medicines Agency’s Committee for Medicinal Products for Human Use designated Janssen’s RSV adult vaccine candidates as eligible for the Priority Medicines (PRIME) program based on promising clinical data and unmet needs for the prevention of RSV in the elderly.
For more information about Janssen's commitment to fight infectious diseases, please visit www.janssen.com/infectious-diseases-and-vaccines/IDV-News/.
About Respiratory Syncytial Virus (RSV) Respiratory Syncytial Virus (RSV) is a popular and highly contagious respiratory virus. It is the main cause of bronchitis, bronchiolitis and pneumonia. It affects more than the world in a typical year. 64 million people. Because the symptoms of RSV are difficult to distinguish from influenza or other respiratory infections (such as COVID-19), many people infected with RSV are still undiagnosed. There are currently no vaccines or widely available antiviral drugs to prevent or treat RSV in the elderly.
The elderly, young children, and people with underlying health problems are most at risk. RSV disproportionately affects adults over 60 and high-risk adults over 18, who are more likely to develop upper and lower respiratory tract disease (LRTD). In a typical year, 3-7% of the elderly (60 years and older) and 4-10% of high-risk adults (18 years and older) experience RSV.
About CYPRESS (NCT03982199) CYPRESS is a randomized, double-blind, placebo-controlled Phase 2b trial to study the safety and effectiveness of adult vaccine candidates for Janssen Respiratory Syncytial Virus (RSV). The trial recruited 5,782 participants aged 65 years and older (2,891 per study group). Before the RSV season, participants randomly receive Janssen's adult RSV vaccine candidate or placebo at a ratio of 1:1. For more information, please refer to: https://clinicaltrials.gov/ct2/show/NCT03982199.
Get full access to all new and archived articles, unlimited portfolio tracking, email alerts, custom news lines and RSS feeds-and more!