ENSEMBLE 2 - Phase 3 COVID-19 Vaccine Study - VAC31518COV3009 [COVID-19] [UPH]
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
IRAS ID
288552
Contact name
Saul Faust
Contact email
Sponsor organisation
Janssen Vaccines & Prevention B.V.
Eudract number
2020-003643-29
ISRCTN Number
ISRCTN14722499
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND, 22657
Duration of Study in the UK
2 years, 9 months, 26 days
Research summary
The Sponsor is developing a COVID-19 vaccine in response to the COVID-19 pandemic. The main purpose of the study is to demonstrate the safety and effectiveness of the Sponsor’s vaccine for the prevention of COVID-19.
The study will include participants 18 years of age and older with and without existing health conditions that are thought to be linked with increased risk of developing severe COVID-19 symptoms.
The total number of participants worldwide will be 30,000 with half receiving the Sponsor’s vaccine candidate and the other half receiving placebo. There will be 2 doses of the vaccine or placebo given to all participants. In the UK about 6000 participants are expected to take part in the study.
Participants will be followed for a maximum of 2 years and 3 months for ongoing COVID-19 signs and symptoms (to determine duration of protection), for 1 year after the 2nd vaccination each participant will be asked at least twice a week via the electronic clinical outcome assessment (eCOA) tool, if they have experienced any new symptoms or health concerns that could be related to infection with SARS-CoV-2. From 1 year after the 2nd vaccination, until the end of the 2-year follow-up period, the frequency of this surveillance question through the eCOA will decrease to once every 2 weeks. All cases meeting criteria for symptomatic COVID-19 infection will be confirmed via laboratory testing and additional assessments, including nasal swabs, vital signs and blood samples will be collected. Additional assessments will continue until 14 days after symptom onset (COVID-19 Day 15) or until resolution of the COVID-19 episode, whichever comes last, unless it is confirmed that both confirmatory nasal swabs collected on COVID-19 Day 1-2 and Day 3-5 are negative for SARS-CoV-2
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0317
Date of REC Opinion
10 Nov 2020
REC opinion
Further Information Favourable Opinion