(RTTNews) - AstraZeneca Plc. (AZN, AZN.L) said Monday that the interim Phase I/II trial data showed that COVID-19 vaccine candidate is safe and induced immune response.
The company is developing a cornoavirus vaccine by the name AZD1222, in partnership with the University of Oxford.
The interim results published in The Lancet confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection.
Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University and co-author of the trial, said that the immune responses observed following vaccination are in line with what they expect will be associated with protection against the SARS-CoV-2 virus. But they must continue with clinical trial programme to confirm this. They saw the strongest immune response in participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination.
Phase I/II COV001 trial is a blinded, multi-centre, randomised controlled Phase I/II trial with 1,077 healthy adult participants, aged 18-55 years. It assessed a single dose of AZD1222 against a comparator meningococcal conjugate vaccine, MenACWY. Ten participants also received two doses of AZD1222 one month apart.
According to the company, Neutralising activity against SARS-CoV-2 was seen in 91% of participants one month after vaccination and in 100% of participants who received a second dose. The levels of neutralising antibodies seen in participants receiving either one or two doses were in a similar range to those seen in convalescent COVID-19 patients. Strong correlations were observed across neutralisation assays.
Late-stage Phase II/III trials are currently underway in the UK, Brazil and South Africa and are due to start in the US. Trials will determine how well the vaccine will protect from the COVID-19 disease and measure safety and immune responses in different age ranges and at various doses, the company said.
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