LNP-nCoVsaRNA / Imperial College London - LARVOL DELTA

Implementation and adherence to regular asymptomatic testing in a COVID-19 vaccine trial. (PubMed, Vaccine) - "The COV002 trial demonstrated the feasibility of running a long-term regular asymptomatic testing strategy. This information could be valuable for designing future phase III vaccine trials in which infection is an outcome."

Adherence • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Nanodrug delivery systems for metabolic chronic liver diseases: advances and perspectives. (PubMed, Nanomedicine (Lond)) - "Nanomedicines are revolutionizing healthcare as recently demonstrated by the Pfizer/BioNTech and Moderna COVID-2019 vaccines, with billions of doses administered worldwide in a safe manner...Nanoparticle-based approaches offer novel opportunities for efficient and specific drug delivery to liver cells, as a step toward precision medicines. In this review, the authors highlight recent advances in nanomedicines for the generation of novel diagnostic and therapeutic tools for nonalcoholic fatty liver disease and related liver diseases."

Journal • Review • Hepatocellular Cancer • Hepatology • Infectious Disease • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Novel Coronavirus Disease

COVAC1 phase 2a expanded safety and immunogenicity study of a self-amplifying RNA vaccine against SARS-CoV-2. (PubMed, EClinicalMedicine) - "A phase 2a expanded safety and immunogenicity study of a saRNA SARS-CoV-2 vaccine candidate LNP-nCoVsaRNA, was conducted at participating centres in the UK between 10th August 2020 and 30th July 2021...Boosting of S IgG antibodies was observed with a single 1.0 μg injection in those with pre-existing immune responses. Grants and gifts from the Medical Research Council UKRI (MC_PC_19076), the National Institute for Health Research/Vaccine Task Force, Partners of Citadel and Citadel Securities, Sir Joseph Hotung Charitable Settlement, Jon Moulton Charity Trust, Pierre Andurand, and Restore the Earth."

Journal • P2a data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Detection and Quantification of Antibody to SARS CoV 2 Receptor Binding Domain provides enhanced Sensitivity, Specificity and Utility. (PubMed, J Virol Methods) - "Anti-RBD is also measurable in ferrets immunised with ChadOx1 nCoV-19 vaccine and in humans immunised with both AstraZeneca and Pfizer vaccines. The hybrid DABA also displays the attributes necessary for the detection and quantification of anti-RBD to be used in clinical practice. An absence of detectable anti-RBD by this assay predicates the need for passive immune prophylaxis in at-risk patients."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of a self-amplifying RNA vaccine against COVID-19: COVAC1, a phase I, dose-ranging trial. (PubMed, EClinicalMedicine) - "A phase I first-in-human dose-ranging trial of a saRNA COVID-19 vaccine candidate LNP-nCoVsaRNA, was conducted at Imperial Clinical Research Facility, and participating centres in London, UK, between 19 June to 28 October 2020. Participants received two intramuscular (IM) injections of LNP-nCoVsaRNA at six different dose levels, 0.1-10.0μg, given four weeks apart. Modifications to optimise humoral responses are required to realise its potential as an effective vaccine against SARS-CoV-2. This study was co-funded by grants and gifts from the Medical Research Council UKRI (MC_PC_19076), and the National Institute Health Research/Vaccine Task Force, Partners of Citadel and Citadel Securities, Sir Joseph Hotung Charitable Settlement, Jon Moulton Charity Trust, Pierre Andurand, Restore the Earth."

Clinical • Journal • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Humoral and T-cell responses to SARS-CoV-2 vaccination in patients receiving immunosuppression. (PubMed, Ann Rheum Dis) - "SARS-CoV-2 vaccines are immunogenic in patients receiving immunosuppression, when assessed by a combination of serology and cell-based assays, although the response is impaired compared with healthy individuals. B-cell depletion following rituximab impairs serological responses, but T-cell responses are preserved in this group. We suggest that repeat vaccine doses for serological non-responders should be investigated as means to induce more robust immunological response."

Clinical • Journal • Immunology • Infectious Disease • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant. (PubMed, N Engl J Med) - "Only modest differences in vaccine effectiveness were noted with the delta variant as compared with the alpha variant after the receipt of two vaccine doses. Absolute differences in vaccine effectiveness were more marked after the receipt of the first dose. This finding would support efforts to maximize vaccine uptake with two doses among vulnerable populations. (Funded by Public Health England.)."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

YouTube as a source of public health information regarding COVID-19 vaccination: an assessment of reliability and quality of video content. (PubMed, JMIR Public Health Surveill) - "Overall quality and reliability of information on YouTube regarding COVID-19 vaccines remains poor. Videos produced by educational channels, especially by medical professionals, were higher in quality and reliability than those produced by other sources, including health-related organisations. Collaboration between health-related organisations and established medical and educational YouTube content producers provides an opportunity for dissemination of high-quality information regarding COVID-19 vaccination. Such collaboration holds potential as a rapidly implementable public health intervention aiming to engage a wide audience and increase public vaccination awareness and knowledge."

Journal • Video • Infectious Disease • Novel Coronavirus Disease

Coronavirus (Covid-19) vaccine latest update: Imperial College promises low-cost access to vaccine; China’s first jab by autumn (indianexpress) - "The RNA vaccine developed by Imperial College delivers genetic instructions to muscle cells to make the 'spike' protein on the surface of coronavirus. The presence of this protein provokes an immune response, offering protection against Covid-19. The vaccine is now due to enter phase one and two human clinical trials on June 15 with 300 people. A further trial involving 6,000 people is planned for October and if these prove successful, Imperial hopes the vaccine could be distributed in the UK and abroad early next year."

New P1 trial • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Coagulopathy in COVID19 - A Multi-Centre Observational Study in UK (clinicaltrials.gov) - P; N=5000; Recruiting; Sponsor: Imperial College London

Clinical • New trial • Cardiovascular • Hematological Disorders • Hemophilia • Infectious Disease • Novel Coronavirus Disease • Thrombosis

Mechanisms of Multi-organ Failure in COVID-19 (clinicaltrials.gov) - P; N=120; Not yet recruiting; Sponsor: Imperial College London

New trial • Anesthesia • Infectious Disease • Novel Coronavirus Disease

OnCovid: COVID-19 and Cancer Patients (clinicaltrials.gov) - P; N=50; Recruiting; Sponsor: Imperial College London

Clinical • New trial • Novel Coronavirus Disease • Oncology

Neonatal Complications of Coronavirus Disease (COVID-19) (clinicaltrials.gov) - P; N=500; Recruiting; Sponsor: University of Oxford

New trial • Infectious Disease • Novel Coronavirus Disease

PIONEER: A Randomised Controlled Trial of Early Intervention in COVID-19: Favipiravir Verses HydroxycholorquiNe & Azithromycin & Zinc vErsEs Standard CaRe (clinicaltrials.gov) - P3; N=450; Not yet recruiting; Sponsor: Chelsea and Westminster NHS Foundation Trust

Clinical • New P3 trial

C-19-ACS: Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial. (clinicaltrials.gov) - P=N/A; N=3170; Not yet recruiting; Sponsor: Imperial College London

Clinical • New trial

C-19-ACS: Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial. (clinicaltrials.gov) - P=N/A; N=3170; Recruiting; Sponsor: Imperial College London; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

REMOTE-COVID: Remote Monitoring Use In Cases Of Suspected COVID-19 (Coronavirus) (clinicaltrials.gov) - P; N=200; Not yet recruiting; Sponsor: Imperial College London

New trial