SABRE
Research type
Research Study
Full title
SABRE: A single-arm prospective observational study measuring immune correlates of protection against SARS-CoV-2 virus infection amongst high-risk special populations after subcutaneous dosing of 2 SARS-CoV-2 broadly neutralising antibodies (BMS-986414 and BMS-986413).
IRAS ID
294514
Contact name
Sarah Fidler
Contact email
Sponsor organisation
Imperial College London and Imperial College Healthcare NHS Trust
Eudract number
2021-003033-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The SABRE study is a single arm prospective study measuring immune correlates of protection against SARS-CoV-2 virus infection amongst high risk special populations of vaccine non-responders after subcutaneous dosing of two SARS-CoV-2 broadly neutralising antibodies (bNABs, BMS-986414 and BMS-986413). The primary objectives are to determine the safety, tolerability and durability of subcutaneous injections of BMS-986414 and BMS-986413 at 12 weeks after injection. The study aims to enrol 120 individuals from Imperial College Healthcare NHS Trust and Oxford University NHS Trust. Main eligibility criteria include patients ≥18 years old at screening, have received two doses of a routine SARS-Cov-2 vaccine but do not have detectable serum SARS-CoV-2 anti-spike after 2 weeks post 2nd vaccination. This may include patients that are solid organ transplant recipients, those undergoing active chemotherapy or immunotherapy, cancers of the blood or bone marrow such as leukaemia, lymphoma or myeloma who are at any stage of treatment, have had bone marrow or stem cell transplants in the last 6 months or who are still taking immunosuppression drugs or be ineligible to receive a SARS-CoV-2 prophylactic vaccine due to the need to commence immediate systemic chemotherapy or the need to receive a bone-marrow and therefore the requirement to initiate profound immune suppression. Patients will be followed up for 48 weeks with 11 in-person visits in total. After screening and consent, patients will have the antibodies injected subcutaneously. They will then attend follow-up visits at Weeks 1, 4, 8, 12, 18, 24, 32, 40 and 48 (end of study). At each visit, labs will be drawn to monitor the effect of the bNABs, adverse events recorded and reported and quality of life measured at weeks 12, 24 and 48. The study will take place over 24 months in total.
REC name
London - Fulham Research Ethics Committee
REC reference
21/LO/0659
Date of REC Opinion
27 Oct 2021
REC opinion
Further Information Favourable Opinion