COV001 clinical trial results : AstraZeneca and Oxford University said that interim results from the phase 1/2 COV001 clinical trial showed the ChAdOx1 nCoV-19 vaccine (AZD1222) to be well tolerated besides generating strong responses in all evaluated participants against the COVID-19 causing SARS-CoV-2 virus.
The early-stage COVID-19 vaccine trial is being led by Oxford University, which is collaborating with AstraZeneca for the further development, large-scale manufacturing and potential distribution of the vaccine candidate. The ChAdOx1 nCoV-19 vaccine was co-invented by the UK-based university and its spin-out firm, Vaccitech.
Professor Andrew Pollard – Chief investigator of the Oxford Vaccine Trial at Oxford University and co-author of the trial, commenting on the COV001 clinical trial results, said: “The interim Phase I/II data for our coronavirus vaccine shows that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type. The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial programme to confirm this.
“We saw the strongest immune response in participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination.”
COV001 is designed to be a blinded, multi-center, randomized controlled clinical trial featuring 1,077 healthy adult participants, in the age group of 18-55 years. The COV001 clinical trial is evaluating a single dose of ChAdOx1 nCoV-19 against MenACWY, a comparator meningococcal conjugate vaccine.
According to AstraZeneca, ten participants in the Covid-19 vaccine trial were administered a couple of doses of AZD1222 one month apart.
The COV001 clinical trial results, which were published in The Lancet journal, confirmed a single dose of the Oxford vaccine candidate to have triggered a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants a month after injection. In all participants of the COVID-19 vaccine trial, a T-cell response was induced, which peaked by day 14, and was sustained a couple of months after injection.
AstraZeneca said that the neutralizing activity against the COVID-19 causing virus was noted in 91% of participants a month after vaccination and in all the participants of the COV001 clinical trial who were given a second dose of the Oxford vaccine.
Commenting on the COV001 clinical trial results, Mene Pangalos – AstraZeneca BioPharmaceuticals Research and Development Executive Vice President said: “We are encouraged by the Phase I/II interim data showing AZD1222 was capable of generating a rapid antibody and T-cell response against SARS-CoV-2. While there is more work to be done, today’s data increases our confidence that the vaccine will work and allows us to continue our plans to manufacture the vaccine at scale for broad and equitable access around the world.”
Last week, R-Pharm, a Russian pharma company, had reportedly signed an agreement with AstraZeneca for manufacturing the ChAdOx1 nCoV-19 vaccine in Russia.