Interim results from the ongoing Phase I/II COV001 trial, led by
COV001 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.
The results published in The
Neutralising activity against SARS-CoV-2 (as assessed by the MNA80 assay) 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.
The early safety responses confirmed that transient local and systemic reactions were common in the AZD1222 group and were comparable to previous trials and other adenoviral vector vaccines.1-4 They included temporary injection site pain and tenderness, mild-to-moderate headache, fatigue, chills, feverishness, malaise and muscle ache. No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol, a pain killer, and occurred less frequently after a second dose.
Professor
Late-stage Phase II/III trials are currently underway in the
In parallel, AstraZeneca continues to fulfil its commitment for broad and equitable access to the vaccine, should late-stage clinical trials prove successful. So far, commitments to supply more than two billion doses of the vaccine have been agreed with the
Financial considerations
Today's announcement is not anticipated to impact the Company's financial guidance for 2020 as expenses to progress the vaccine are anticipated to be offset by funding by governments and international organisations.
Immune correlates of protection to COVID-19 disease5
Correlates of protection for a vaccine against COVID-19 have not yet been defined. High levels of neutralising antibodies have been demonstrated in individuals who have recovered from SARS-CoV-2 infection. In addition, emerging data suggest that a T-cell response could play an important role in mitigation of the disease. Some individuals who have been infected with the virus but remained asymptomatic, have developed a robust T-cell response with an absence of detectable antibodies. Rapid induction of antibodies and T-cells against the SARS-CoV-2 virus may be important in protection against COVID-19.
COV001
COV001 is a Phase I/II single-blinded randomised controlled trial to determine safety, immunogenicity and efficacy of the COVID-19 vaccine candidate AZD1222 in up to 1,077 healthy adults in five trial centres in the
Participants had blood samples drawn and clinical assessments for safety as well as immunogenicity at day 0, 28 and will also be followed at day 184 and 364. In addition, participants enrolled in the Phase I component of the study and in the two dose groups, had visits at 3, 7, 14 and 28 days after each vaccination.
AZD1222
AZD1222 was co-invented by the
AstraZeneca
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