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Janssen announces adult respiratory syncytial virus (RSV) vaccine candidate retains significant efficacy regardless of severity of lower respiratory tract disease

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Janssen announces adult respiratory syncytial virus (RSV) vaccine candidate retains significant efficacy regardless of severity of lower respiratory tract disease

First RSV vaccine candidate to show significant efficacy – up to 80% 1

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

“Data from our Phase 2b CYPRESS study brings us one step closer to delivering a potentially first-in-class vaccine to help protect older adults against RSV,” said Penny Heaton, MD, Global Therapeutic Area Head , Vaccines, Janssen Research & Development, LLC. “In the absence of an approved vaccine or widely indicated antiviral available, older people are at high risk of developing serious, life-threatening illness from RSV. We have now shown significant efficacy and believe that our vaccine has the potential to prevent the significant morbidity and mortality caused by RSV each year. “

“RSV activity was unusually high last summer, indicating that seasonal respiratory viruses will definitely be back as the COVID-19 pandemic slows,” said Ann R Falsey, MD, professor of medicine at the faculty of Medicine from the University of Rochester and presenting author. “RSV is increasingly becoming a major global public health problem. These latest data from the CYPRESS Phase 2b study give us all additional hope that this candidate vaccine against RSV has the potential to play a central role in protecting vulnerable populations around the world.

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

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

CYPRESS Phase 2b Study Met All Endpoints

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

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

Janssen’s adult RSV vaccine candidate has been shown to be generally well tolerated

Solicited adverse events (AEs; fatigue, headache, nausea, myalgia, fever, injection site reactions) and unsolicited AEs were assessed from the 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 from all participants until the end of the RSV (primary endpoint) or six months after vaccination, whichever is later.6 In the group vaccine, the most common solicited systemic AEs were fatigue, myalgia and headache, and local AE most frequently called upon was pain / tenderness.6 Rates of unsolicited AEs were similar in the two 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 vaccine-related.6

Janssen’s Adult RSV Vaccine Candidate EVERGREEN Phase 3 Study Already Underway

Based on the positive results of 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 years and over with United States1,2 Janssen initiated the global phase 3 study EVERGREEN .7 The phase 3 study will evaluate the efficacy, safety and immunogenicity of Janssen’s adult vaccine candidate against RSV-induced LRTD compared to placebo in approximately 23,000 adults aged 60 and over in North America and selected countries in Europe, Asia and the Southern Hemisphere.7

In September 2019, the U.S. Food and Drug Administration granted the breakthrough therapy designation to Janssen’s adult RSV vaccine candidate for the prevention of RSV-caused LRTD in adults 60 years of age or older. 8 This was based on clinical data indicating the potential for substantial improvement over the standard of care available on one or more clinically significant endpoints. 8 In November 2020, the Agency’s Committee for Medicinal Products for Human Use European Medicines Agency has designated Janssen’s adult RSV vaccine candidate as eligible for the Priority Medicines Program (PRIME) .9

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