OCTAVE (V1.0, 02-Feb-2021) [Covid -19]
Research type
Research Study
Full title
OCTAVE: Observational Cohorts Trial - T-cells Antibodies and Vaccine Efficacy in SARS-CoV-2
IRAS ID
294480
Contact name
Iain McInnes
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2021-000569-33
ISRCTN Number
ISRCTN12821688
Clinicaltrials.gov Identifier
CRCTU Ref No., MX1034
Duration of Study in the UK
1 years, 5 months, 17 days
Research summary
The rapid development of vaccines for corona virus has been a major step forward in the battle against this disease. Vaccines work by training the body’s immune system (the way the body defends itself) to fight a new disease.
A national vaccination programme is underway for the vaccines approved by the UK regulatory authority. Prior to approval these vaccines were tested on healthy volunteers. Questions remain as to how well these vaccines will work in patients with chronic illnesses whose immune system may not be working at full strength due to their illness or the treatments they are receiving for their disease.
The OCTAVE trial will collect information and research samples from patients with chronic illnesses who are receiving the coronavirus vaccine as part of the national vaccination programme. Patients with a range of healthcare conditions including rheumatic conditions, liver disease, renal disease, cancer, and patients who have had a stem cell transplant, will be asked to participate.
Blood and saliva samples will be collected at up to 5 time points and the immune response assessed by specialist laboratories. Patients will be allocated to one of two groups by their research doctor: Group 1 (Deep Immunotherapy Group) and Group 2 (Serology Group). The research samples from Group 1 (150 patients per disease type), will undergo a detailed examination (analysis) of the immune response while the samples from patients in Group 2 (up to 850 extra patients per disease type) will undergo a more restricted analysis.
Patients from hospitals around the UK will be recruited over a 6 month period. Information on these patients (for example their disease type, the treatments they are receiving, and whether they go on to develop coronavirus after vaccination) will be collected for 6 months.
REC name
London - Chelsea Research Ethics Committee
REC reference
21/HRA/0489
Date of REC Opinion
9 Feb 2021
REC opinion
Favourable Opinion