► Oxford/Astrazeneca COVID-19 vaccine trials
- A phase I/II study to determine efficacy, safety, and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers.
- A phase II/III study to determine the efficacy, safety, and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19.
The CRF provided facilities to help deliver these high-profile trials led by the Oxford Vaccine Group during the first lockdown. The results of these studies have had a massive global impact with the vaccine deployed across the planet.
► Novavax COVID-19 vaccine trial
The CRF at Oxford Health NHS Foundation Trust is one of the UK sites for the Novavax COVID-19 vaccine trial, a Phase 3, Randomised, Observer-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant in Adult Participants 18-84 Years of Age in the United Kingdom.
The results showed this vaccine is 89.3% effective against COVID-19. Novavax is currently seeking approval from the MHRA for emergency authorisation of the vaccine in the UK, as well as from regulatory bodies globally. Once approval has been obtained the vaccine will be made available to the UK general public.
► COVID-19 and mental health
In the context of the COVID-19 pandemic and its effect on the management of mental health, a group from the CRF rapidly developed evidence-based syntheses of guidance on a wide range of relevant topics. The resource has been made available on an open-access webpage as part of the Oxford Health BRC, within the Oxford Precision Psychiatry Lab. It was developed in collaboration with national and international experts and is signposted from the Royal College of Psychiatrists’ website. The guidance has been translated into six different languages.
► Experimental medicine
Research on Emotional effects of SeroTonin agonism in ResistanT depression (RESTART) and Research on Emotional effects of SeroTonin agonism in Non-medicated Depression (RESTAND) are Oxford Health BRC adopted studies that investigate a novel serotonin receptor subtype 4 (5HT4) agonist as a potential new treatment for depression and treatment-resistant depression.
These studies are the first to investigate the translation of consistent findings in animal literature indicating that 5HT4 agonism has significant potential to alleviate symptoms of depression and anxiety, by exploring the effects in patients with depression.
SINAPPS2 is a phase II ongoing clinical trial aiming to test the efficacy and safety of immunotherapy (intravenous immunoglobulin combined with rituximab) versus placebo treatment in people with acute symptoms of psychosis and anti-neuronal membrane antibodies.
MIcroglial CSF1R in Alzheimer’s Disease (MICAD) investigates the effects of a new compound on biomarkers of early AD.
Deep and Frequent Phenotyping (DFP)’ a repeated measures observational design in prodromal Alzheimer’s disease, a highly-focused biomarker study combining both established and novel markers to identify a marker set for measuring outcome in prodromal disease proof of concept trials and in addition, to establish a sample bank for further exploratory studies.
The New Therapeutics in Alzheimer’s Disease study (NTAD) is looking to detect biomarkers of AD before symptoms show, these markers will be used to test whether experimental treatments can delay the progression of the disease. The study is testing new brain scans including MRI and MEG that are revealing early changes in the brain that are a signature of Alzheimer’s.
► Treatment-resistant depression
PAX-D is a randomised placebo-controlled trial evaluating the efficacy and mechanism of pramipexole as an add-on treatment for people with treatment-resistant depression. This NIHR funded Oxford-led trial is looking at a novel treatment for depression and is part of the mental health Translational Research Collaboration (Depression).