AstraZeneca Research Specimen Collection Programme (RSCP)
Research type
Research Study
Full title
COVID-19 Research Specimen Collection Programme (COVID-19 RSCP) in Healthy Volunteers to Support AstraZeneca COVID19 Research Projects
IRAS ID
303844
Contact name
Beata Maj
Contact email
Sponsor organisation
AstraZeneca UK Ltd.
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
The AZ COVID-19 Research Specimen Collection Programme (RSCP) will enable the creation of an internal AZ biorepository, which will allow the AZ vaccine and therapeutics teams to access a readily available resource of appropriately collected samples to generate research data.
These data may aid, and will be complementary to research performed by AZ, and elsewhere, for the better understanding of the COVID 19 epidemiology and post vaccination immunity. In addition, it is hoped that this research will help support future vaccine and antibody development. PCR, antigen and other assays evaluation may allow AZ to define novel future vaccination and/or diagnostic strategies to manage COVID-19.
This research may help us better understand the epidemiology of virus variants and these biosamples will also be important for the verification of performance (i.e., the sensitivity and specificity) of genome sequencing and antigen assays designed to detect specific SARS-CoV-2 variants. No host genetic testing will be conducted as part of this COVID-19 RSCP.
Overall design:
This is a COVID-19 RSCP to facilitate the collection of biosamples (saliva and blood) from heathy volunteers. The COVID-19 RSCP will be open to AstraZeneca (AZ) employees who are participating in the AZ COVID 19 Internal Employee Assessment Programme.
It is anticipated that between 700 and 1,250 AZ employees based at AZ sites in the US and Europe will participate in the COVID-19 RSCP. Participants will be asked to donate samples for a total of 2 years from the time of enrolment providing blood samples (2 x 8.5 mL) on a quarterly basis for biobanking and research purposes. Participants who test positive for the SARS-CoV-2 virus via PCR testing conducted as part of the AZ COVID-19 Internal Assessment Programme will be asked to donate their saliva sample to the COVID-19 RSCP.REC name
Wales REC 5
REC reference
21/WA/0339
Date of REC Opinion
12 Nov 2021
REC opinion
Further Information Favourable Opinion