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Imperial College advances Covid-19 vaccine into next phase
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Download the PDF here
Imperial College London in the UK has advanced its Covid-19 vaccine candidate into the next phase of the COVAC1 clinical trial following the success in the initial dose escalation phase involving 15 volunteers.
The latest phase of the study will enrol 105 participants aged 18-75 who will be given one of three doses of the vaccine candidate at a facility in west London. This first shot will be followed by a booster four weeks later.
Imperial College London in the UK has advanced its Covid-19 vaccine candidate into the next phase of the COVAC1 clinical trial following the success in the initial dose escalation phase involving 15 volunteers.
The latest phase of the study will enrol 105 participants aged 18-75 who will be given one of three doses of the vaccine candidate at a facility in west London. This first shot will be followed by a booster four weeks later.
Participants in the initial phase will also receive their second booster dose in the coming days.
The clinical team will track any potential adverse reactions, as well as test participants' blood samples for the presence of neutralising antibodies against the SARS-CoV-2 virus, which causes Covid-19.
Imperial College London professor Robin Shattock said: "Analysing blood samples for antibodies and T-cell response will provide some indication of whether our vaccine can produce an immune response to fight the virus.
"Larger clinical trials will still be needed to tell us whether our vaccine candidate, and any other Covid-19 vaccine in development, may be successful in reducing the spread or severity of Covid-19."
Imperial College's Covid-19 vaccine candidate is based on new self-amplifying RNA (saRNA) technology. It was subjected to preclinical studies and animal tests found the vaccine to be safe, with the potential to generate an effective immune response.
The trial will assess the vaccine candidate's tolerability and effectiveness in generating an immune response.
According to researchers, the vaccine leverages synthetic strands of RNA based on the virus' genetic material. Upon injection into the muscle, the RNA self amplifies and induces the body's cells to produce copies of a spike protein present on the virus.
This is expected to train the immune system to identify and protect against Covid-19. The UK Government has provided more than £41m in funding to support development and clinical studies of the vaccine.
In pre-clinical safety tests and animal studies, the vaccine was observed to be safe and demonstrated encouraging signs of an effective immune response, noted the researchers.
The Phase I/II trials will assess two doses of the vaccine in 300 healthy participants. Based on the results, Phase III effectiveness studies will be performed later this year in nearly 6,000 healthy volunteers.
According to preclinical data published in Nature Communications journal, two doses of the vaccine were able to generate highly specific antibodies that could neutralise the virus in mice.
Imperial College started dosing participants in the COVAC1 trial last month.
The development and clinical trials of this Covid-19 vaccine candidate are supported by more than £40m in funding from the UK Government and additional financing in philanthropic donations.
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COVID-19 vaccine development and a potential nanomaterial path forward
Abstract
The COVID-19 pandemic has infected millions of people with no clear signs of abatement owing to the high prevalence, long incubation period and lack of established treatments or vaccines. Vaccines are the most promising solution to mitigate new viral strains. The genome sequence and protein structure of the 2019-novel coronavirus (nCoV or SARS-CoV-2) were made available in record time, allowing the development of inactivated or attenuated viral vaccines along with subunit vaccines for prophylaxis and treatment. Nanotechnology benefits modern vaccine design since nanomaterials are ideal for antigen delivery, as adjuvants, and as mimics of viral structures. In fact, the first vaccine candidate launched into clinical trials is an mRNA vaccine delivered via lipid nanoparticles. To eradicate pandemics, present and future, a successful vaccine platform must enable rapid discovery, scalable manufacturing and global distribution. Here, we review current approaches to COVID-19 vaccine development and highlight the role of nanotechnology and advanced manufacturing.
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