Safety and immunogenicity of the ChAdOx1nCoV-19 vaccine against SARS-CoV-2: a Phase I/2 randomized control trial
The Phase 1 data for our coronavirus vaccine shows that the vaccine raised no safety concerns, did not lead to any unexpected symptoms in those who received it, and was very similar to other vaccines of this type.
The immune responses that were made following vaccination are exactly the kind of responses that we think might be associated with protection, though we must continue with our rigorous clinical trial programme to confirm whether the responses we have seen are sufficient. Importantly, we saw an even greater immune response in participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination.
These encouraging results support large scale evaluation of this candidate vaccine in an ongoing Phase III programme, that is still needed to prove the vaccine will protect people from the virus.
[-]Immunogenicity – Antibodies
Antibodies play an important role in the immune response to viruses. This study assessed both the quantity and quality of antibody found in participant blood samples, compared with samples from COVID-19 patients. An ELISA assay was used to measure the quantity of antibodies in the blood that recognise the spike protein. Following a single vaccination all participants produced spike specific antibody by 14 days, with the antibody response peaking at 28 days. This response was well maintained up to 56 days post vaccination showing potential for long term maintenance of the antibody response. In participants who received a second boost vaccination at 28 days, there was a further increase in the peak response. The levels of responses observed in vaccinated individuals are comparable to those seen in recovering COVID-19 patients.
De klinische testfase startte in april van dit jaar.
Oxford’s COVID-19 vaccine clinical trials began in April 2020. The main focus of the Phase I, II and III studies is to assess whether the ChAdOx1 nCoV-19 vaccine is going to work against COVID-19, if it won’t cause unacceptable side effects and if it induces good immune responses.
Phase I/II1,077 participants were recruited beginning in April 2020 across multiple study sites in Oxford, Southampton, London and Bristol. Participants were randomly allocated to receive either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that is used as a ‘control’ for comparison. The dose used in this trial was chosen based on previous experiences with other ChAdOx1 based vaccines.
There was also a separate small group of 10 volunteers who received 2 doses of ChAdOx1 nCoV-19 four weeks apart.
https://www.research.ox.ac.uk/Article/2020-07-19-the-oxford-covid-19-vaccine
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