Phase II/III Study of AZD2816 for the Prevention of COVID-19 in Adults [COVID-19]
Research type
Research Study
Full title
A Phase II/III Partially Double-Blinded, Partially Randomised, Multinational, Active-Controlled Study in Both Previously Vaccinated and Unvaccinated Adults to Determine the Safety and Immunogenicity of AZD2816, a Vaccine for the Prevention of COVID-19 Caused by Variant Strains of SARS-CoV-2
IRAS ID
300677
Contact name
Gillian Traynor
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-002530-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 27 days
Research summary
Summary of Research
Coronaviruses are usually respiratory viruses and most often cause common-cold like symptoms every winter. SARS-CoV-2 is a new coronavirus that appears to have first emerged in November 2019 causing as of April 25, 2021 more than 163 million confirmed cases of COVID-19 and more than 3 million deaths worldwide. As a response to the ongoing pandemic, AstraZeneca has developed a vaccine, known as AZD1222, for the prevention of COVID-19. AZD1222 is approved for use in the European Union, and several countries around the world.
Recently, new forms of SARS-CoV-2, called variants, have been found in some countries around the world. These variants may allow the virus to spread more easily among people, make COVID-19 vaccines work less well, or both. AZD2816 is being developed based on the AZD1222 vaccine. The AZD1222 vaccine is based on a weakened and changed version (so it cannot make more of itself inside the human body) of a common cold (adenovirus) virus that causes infections in chimpanzees. The vaccines work by presenting parts of the virus (SARS-CoV-2) that causes COVID-19 to the body so that an immune response can be made to it.
The purpose of this study is to learn more about whether AZD2816 and AZD1222 can prevent COVID-19 infection.
Participants who are eligible for this study will be:
1. 18 years old or older
2. have received 2 doses of a COVID-19 vaccine (3-12 weeks apart) in the past 3 months OR have not received any COVID-19 vaccine
3. are not currently infected with SARS-CoV-2, or known to have been infected with it in the past
4. If they have been infected with SARS-CoV-2 virus in the past, their study doctor may invite the participant in the study as well depending on their current health status
This study will take place at UK hospitals and Clinics and participants will be in the study for about 6 months and have 5 scheduled visits (Days 1, 8, 15, 29, and 180) to the study centre.
In addition, about 165 participants who meet screening criteria 1 and 2 only will be invited to participate.Summary of Results
The lay summary of study results will be available on 1st August 2023.REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0200
Date of REC Opinion
17 Jun 2021
REC opinion
Further Information Favourable Opinion