A trial to evaluate SARS-CoV-2 Recombinant Nanoparticle vaccine [COVID-19] [UPH]
Research type
Research Study
Full title
A Phase 3, Randomised, Observer-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant in Adult Participants 18-84 Years of Age in the United Kingdom
IRAS ID
288793
Contact name
Paul Heath
Contact email
Sponsor organisation
Novavax, Inc.
Eudract number
2020-004123-16
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
Coronaviruses are a large family of viruses that cause illness ranging from the common cold to more severe diseases like pneumonia. In December 2019, an outbreak caused by a new coronavirus called “SARS-CoV-2”, which causes the respiratory disease “COVID-19”, started and has since spread to many countries around the world.
Novavax, Inc. is developing a laboratory-made vaccine intended for administration with an adjuvant, a substance that increases the body’s immune response, for the prevention of COVID-19.
Participants will be 18 to 84 years of age in the UK. Every effort will be made to identify regions of high SARS-CoV-2 activity, and people within these regions at high risk of exposure to the virus. An effort will be made to enrol a target of at least 25% of participants who are 65 years of age and above, as well as prioritising other groups that are most affected by COVID-19, including racial and ethnic minorities. There will be approximately 9000 participants taking part in the study. Participants will be blindly and randomly assigned in a 1:1 ratio to receive either the study vaccine or placebo.
The study will consist of the screening period (Days -30 to 0); study vaccination days (Days 0 and 21); and follow-up outpatient study visits on Day 35 and at 3, 6, and 12 months after last study vaccination. The duration of participation will be a maximum of 1 year after last study vaccination. After signing informed consent, participants may be screened within a window of up to approximately 30 days. Nose or Throat swabs will be taken during the study to detect SARS-CoV-2, if the participant has any COVID-19 symptoms or significant exposure history.
Novavax, Inc. is the sponsor of this study.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0399
Date of REC Opinion
21 Sep 2020
REC opinion
Further Information Favourable Opinion