COVID19 Antibody Correlates of Protection [COVID-19]
Research type
Research Study
Full title
The collection of serum for the production and characterisation of Serological Reference Standards for Sars-CoV-2
IRAS ID
287006
Contact name
Maria Zambon
Contact email
Sponsor organisation
UKHSA
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Sars-CoV-2 has emerged as a novel pandemic virus of global importance. As use of diagnostic tests for antibodies against the virus has increased, there is now a requirement to evaluate how protective different levels of antibodies are. Convalescent serum (blood that is obtained from someone who has recovered from disease) can protect against reinfection and be developed into serum standards (a reference sample). Serum standards can improve antibody testing and facilitate pre-clinical and early clinical development and selection of vaccines without the need for expensive studies. An important component of a serum standard is the minimum level of antibody required to protect against infection - this will be determined by seeing how well the convalescent plasma material prevents infection in a suitable animal model.\n\nThe study is being carried out by NIBSC, the global leader in the development of WHO established International Standards and reference materials, in partnership with PHE and NHSBT.\n\nWe propose to approach individuals who have had a positive result for anti-SARS-CoV-2 antibodies. If they consent, a single donation of serum will be taken approximately 1 month after infection by NHS Blood & Transplant, when they will no longer be infected by the virus but should have antibodies against the infection. Samples would then be anonymised and sent to NIBSC to be tested for the presence and strength of antibodies against Sars-CoV-2 using both commercially available assays and in vivo (animal) models before being blended together (if appropriate) with other donations to produce a Sars-CoV-2 serological standard. The standard would be freeze dried to ensure its longevity and shared with the global community.\n\nWhile the research at NIBSC has already received the relevant approvals, we require ethical approval to approach potential donors to obtain their consent to use their convalescent plasma for this research. [Study relying on COPI notice]
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
20/LO/0971
Date of REC Opinion
7 Aug 2020
REC opinion
Further Information Favourable Opinion