The rapid development and subsequent authorisation of vaccines against SARS-CoV-2 has been a major step forward for medical science. In the UK, three vaccines are already approved by the Medicines and Healthcare products and Regulatory Agency (MHRA), the COVID-19 mRNA Vaccine BNT162b2 (Pfizer/BioNTech), COVID-19 Vaccine AstraZeneca (formerly AZD1222), and the mRNA vaccine developed by Moderna (COVID-19 Vaccine Moderna).
It is likely that further vaccines will become available in the coming months. National vaccination programmes have been initiated in the UK for Pfizer-BioNtech and the Astra-Zeneca vaccines. The populations evaluated in the trials of these vaccines were generally healthy volunteers. Therefore questions remain about the level of protection these vaccines will afford patient populations with chronic illnesses who may have primary or secondary immune deficiencies and, therefore, may not generate the same protective responses observed in healthy volunteers.
The OCTAVE trial is a multi-centre, multi-disease, prospective observational cohort trial of the immune response to SARS-CoV-2 vaccination. We will evaluate immunity arising from receipt of the COVID-19 Vaccine AstraZeneca, COVID-19 mRNA Vaccine BNT162b2 and COVID-19 Vaccine Moderna or other MHRA approved SARS-CoV-2 vaccines implemented in the UK. Participants with end stage kidney disease, liver and inflammatory bowel disease, cancer, immune-mediated rheumatic diseases, and transplant recipients attending specialist clinics across the UK will be recruited
Cohorts of approximately 150 patients per disease group will be recruited for full immune response analysis (“Deep Immunophenotyping Group”). Additional participants will be recruited, up to 850 per disease group, for serology analysis (“Serology Group”).
Supplementary vaccine response studies are ongoing across the UK, including Department of Health and Social Care funded analyses of responses in health care workers, care homes, and in BAME groups. Through use of common immune assay platforms, our data will be directly comparable with these emerging datasets allowing comparison with matched controls.