COVAXAER01
Research type
Research Study
Full title
A phase I study to determine safety and immunogenicity of the candidate COVID-19 vaccine AZD1222 delivered by aerosol in healthy adult volunteers.
IRAS ID
289344
Contact name
Christopher Chiu
Contact email
Sponsor organisation
Imperial College London
Eudract number
2020-004508-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 30 days
Research summary
This UKRI-funded study aims to determine the safety and immunogenicity of a single dose of the candidate COVID-19 vaccine, AZD1222, when delivered by aerosol inhalation (a needle free vaccination strategy) in healthy adult volunteers. This strategy could potentially both prevent severe disease and also better block transmission.
AZD1222 is made from the virus, ChAdOx1, which is a weakened version of a common cold virus (adenovirus) from chimpanzees that has been genetically modified, so that it cannot survive and replicate in humans. Also added to the ChAdOx1 virus is the gene that makes a protein from SARS-CoV-2, called Spike Glycoprotein (S), which is thought to be a main target for immune responses.
Following successful screening, healthy volunteers aged 18-45 who are negative for previous SARS-CoV-2 infection and chronic conditions as per the protocol exclusion criteria will be allocated to 1 of 3 dosing cohorts to receive either a low, medium or high dose of the AZD1222 study vaccine. Following receipt of the study vaccine, volunteers will be followed-up for 12 months.
Recruitment will take place in a step wise manner to ensure volunteers safety. The first volunteer will receive the lowest dose of vaccine and then providing there are no safety concerns after 48 hours, a further two more volunteers will be invited to receive the lowest dose of vaccine and again assessed after 48 hours for any side effects. The safety profile will then be assessed by an Data Safety Monitoring Board (DSMB) before escalating to the next dose cohort. This will then be repeated (if no safety concerns) for the medium and high dose of vaccine, until the target recruitment of 15 volunteers is reached; with 3 volunteers receiving the low and medium dose and 6 volunteers receiving the highest tolerated dose of vaccine after safety review.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0094
Date of REC Opinion
20 Apr 2021
REC opinion
Further Information Favourable Opinion