Janssen Announces Respiratory Syncytial Virus (RSV) Adult Vaccine Candidate Maintains Significant Efficacy Regardless of Lower Respiratory Tract Disease Severity

Janssen Announces Respiratory Syncytial Virus (RSV) Adult Vaccine Candidate Maintains Significant Efficacy Regardless of Lower Respiratory Tract Disease Severity

First RSV vaccine candidate to show significant efficacy – up to 80 percent1

NEW BRUNSWICK, N.J., 7 December 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced vaccine efficacy and safety data from its Phase 2b CYPRESS study of its respiratory syncytial virus (RSV) adult vaccine candidate.1,2 Results show that the vaccine candidate was effective in protecting against three clinical definitions of lower respiratory tract disease (LRTD) caused by RSV, demonstrating vaccine efficacy of 69.8 (CI, 43.7-84.7%) to 80 (CI, 52.2-92.9%) percent in adults aged 65 and older.1 These data were presented at the Eighth European Scientific Working Group on Influenza (ESWI) meeting, held virtually from 4–7 December 2021.

“Data from our Phase 2b CYPRESS study bring us another step closer to delivering a potentially first-in-class vaccine to help protect older adults from RSV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “With no approved vaccine or broadly indicated antiviral available, older adults are at high risk of developing serious, potentially life-threatening illness from RSV. We have now shown significant efficacy and believe our vaccine has the potential to prevent the significant morbidity and mortality caused by RSV every year.”

“RSV activity was unusually high this past summer, indicating that the seasonal respiratory viruses will definitely be back as the COVID-19 pandemic slows,” said Ann R Falsey, M.D., Professor of Medicine, University of Rochester School of Medicine and presenting author. “Increasingly, RSV is becoming a major global public health concern. These latest data from the Phase 2b CYPRESS study give us all further hope that this RSV vaccine candidate has the potential play a pivotal role in protecting vulnerable populations worldwide.”

Following an initial proof-of-concept study with Janssen’s RSV adult vaccine candidate (Ad26.RSV.preF component only) in a human challenge study,3 Janssen combined Ad26.RSV.preF with a prefusion F (preF) protein for induction of a more optimal immune response.4,5 This combination single-dose regimen4 was evaluated in the Phase 2b CYPRESS study, which enrolled 5,782 participants across 40 sites in the United States.

1,2 Participants were randomised to receive Ad26.RSV.preF or placebo (n=2891 in each group) and were followed through one RSV season.1,2

The Phase 2b CYPRESS study met all endpoints

The CYPRESS study primary endpoint was the first occurrence of LRTD (lower respiratory tract disease) caused by RSV, during the first RSV season following vaccination, according to any of three case definitions: (1) ≥3 symptoms of lower respiratory tract infection (LRTI), (2) ≥2 symptoms of LRTI, or (3) ≥2 symptoms of LRTI or ≥1 symptom of LRTI with ≥1 systemic symptom.1 Vaccine efficacy for LRTD case definitions 1, 2, and 3 were 80 percent (CI, 52.2-92.9%), 75 percent (CI, 50.1-88.5%), and 69.8 percent (CI, 43.7-84.7%), respectively.1 Efficacy was 69.8 percent (CI, 42.7-85.1%) for the first occurrence of any symptomatic RSV-associated acute respiratory infection (ARI).1

Similarly, RSV-specific patient-reported outcomes data from the CYPRESS trial found less severe RSV symptoms in participants with RSV-associated ARI in the vaccine group than in the placebo group. Vaccinated participants who experienced RSV-associated ARI had milder symptoms and a faster return to usual health than the participants in the placebo group.1

Janssen’s RSV adult vaccine candidate was shown to be generally well-tolerated

Solicited adverse events (AEs; fatigue, headache, nausea, myalgia, fever, injection site reactions) and unsolicited AEs were assessed from time of vaccination (Day 1) to Day 8 and Day 29, respectively, in a safety subset of 695 participants (vaccine, n=348; placebo, n=347).6 Serious AEs (SAEs) were collected in all participants until the end of the RSV season (primary endpoint) or six months post-vaccination, whichever occurred later.6 In the vaccine group, the most frequent solicited systemic AEs were fatigue, myalgia and headache, and the most frequent solicited local AE was pain/tenderness.6 The rates of unsolicited AEs were similar in both groups (vaccine, 16.7%; placebo, 14.4%); in the overall study population, the rate of SAEs was similar between groups (vaccine, 4.6%; placebo, 4.7%), and none were found to be related to the vaccine.6

Phase 3 EVERGREEN study of Janssen’s RSV adult vaccine candidate is already underway

Based on positive results from the Phase 2b CYPRESS study, which evaluated 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,1,2 Janssen initiated the global Phase 3 EVERGREEN study.7 The Phase 3 study will evaluate the efficacy, safety and immunogenicity of Janssen’s adult vaccine candidate against LRTD caused by 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.7

In September 2019, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for Janssen’s RSV adult vaccine candidate for the prevention of LRTD caused by RSV in adults aged 60 years or older.8 This was based on clinical data indicating the potential for substantial improvement compared to available standard of care on a clinically significant endpoint(s).8 In November 2020, the European Medicines Agency’s Committee for Medicinal Products for Human Use designated Janssen’s RSV adult vaccine candidate as eligible for the priority medicines (PRIME) scheme.9

For more information on Janssen’s commitment to battling infectious diseases, visit: https://www.janssen.com/emea/our-focus/infectious-diseases-vaccines.