EVERGREEN (VAC18193RSV3001)

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older

• IRAS ID

  298870

• Contact name

  Andrew Peter Ustianowski

• Contact email

  Andrew.Ustianowski@mft.nhs.uk

• Sponsor organisation

  Janssen Vaccines & Prevention B.V.

• Eudract number

  2020-005458-97

• Duration of Study in the UK

  1 years, 8 months, 1 days

• Research summary

  This research study is being done to learn demonstrate efficacy of the Ad26.RSV.preF-based study vaccine in the prevention of RSV-mediated lower respiratory tract disease (LRTD) when compared to placebo in adults aged 60 years and above from the time of study vaccination until the end of the second RSV season.

  Respiratory syncytial virus (RSV) is a seasonal virus that infects the airways of the lungs. Healthy adults usually experience very mild cold-like symptoms and recover in a few days. In adults aged 60 years and older, in individuals with weakened immune systems, and in individuals with chronic heart and lung conditions, RSV is an important cause of serious infections and can lead to hospitalization and, in some cases, death.

  Up to 23,000 participants will be enrolled and randomized in parallel in a 2:1 ratio to 1 of 2 groups to receive active study vaccine or placebo. By the end of their participation in the study, they will have had:
  • a 1:3 chance of receiving 2 doses of Ad26/protein preF RSV
  • a 1:3 chance of receiving 2 doses of placebo
  • a 1:3 chance of receiving 1 dose Ad26/protein preF RSV and 1 dose placebo

  Since the study is double blind the participants will not know whether they are receiving the study drug or comparator.

  Adult participants with 60 years of age or older will be eligible to participate in this study if they meet all of the inclusion criteria and none of the exclusion criteria as listed in the study Protocol.

  Participants will receive 2 vaccinations during their time in the study. After Screening (Day 1), participants will receive their first dose of the study vaccine (Day 1). Participants will return to the study clinic on Day 365 to receive a second dose of the study vaccine or placebo.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  21/EM/0179

• Date of REC Opinion

  29 Jul 2021

• REC opinion

  Favourable Opinion