A first in human study of OraPro-COVID-19 in healthy volunteers [COVID-19]
Research type
Research Study
Full title
A two-part adaptive, randomised, double-blind, placebo-controlled, dose escalation study to assess the safety, tolerability, immunogenicity, and effectiveness in protecting against SARS-CoV-2 infection of a one and/or two-dose vaccination regimen of OraPro-COVID-19™ vaccine in healthy participants.
IRAS ID
285394
Contact name
Annelize Koch
Contact email
Sponsor organisation
Stabilitech Biopharma Ltd
Eudract number
2020-002786-33
Duration of Study in the UK
0 years, 11 months, 5 days
Research summary
The purpose of this study is to assess the safety, tolerability and activity of OraPro-COVID-19™. The study will investigate the effects of OraPro-COVID-19™ when given at 4 different dose strengths (starting at the lowest and gradually increasing).
This vaccine is being developed for the prevention of and protection against the SARS-CoV-2 infection, commonly referred to as COVID-19.
This vaccine is classified as a genetically modified organism (GMO). The vaccine is made up of a non-replicating adenovirus, which has had its genetic code modified to enable it to produce the spike protein which is found on the outside of the COVID-19 virus. The purpose of this modification is to stimulate an immune response against the spike protein of the COVID-19 virus within the body; such an immune response could provide protection and immunity against COVID-19 without causing the infection itself.
The study will be split into 2 parts. Part A will evaluate 4 different dose strengths of the vaccine (starting with the lowest dose in Group 1 to the highest dose in Group 4) where the vaccine will be given on 2 occasions (once on Day 0 and once on Day 21). In the final group in Part A (Group 5), a single dose of the vaccine will be given on Day 0 at the same dose level as investigated in Group 4. Part A will comprise of 50 healthy volunteers (5 groups of 10).
Part B of the study will involve administration of the vaccine on 1 or 2 occasions in up to 1000 volunteers who are at high risk of contracting COVID-19 for example frontline healthcare workers, and will investigate one of the dose strengths which was evaluated in Part A considered to be the most appropriate.
The study will be undertaken at several research sites across the UK.
REC name
Wales REC 2
REC reference
20/WA/0202
Date of REC Opinion
25 Sep 2020
REC opinion
Further Information Favourable Opinion