AstraZeneca launched the Phase III trial for its COVID-19 vaccine AZD1222 in the US, which they are co-developing with the University of Oxford. 30,000-patients will participate in the trial.
The Phase III D8110C00001 trial (NCT04516746) will evaluate the efficacy, safety, and immunogenicity of the COVID-19 vaccine AZD1222. Two doses of either AZD1222 or a saline control will be given in four weeks apart to randomized patients. Those receiving the potential vaccine will be twice in number compared to those receiving saline control.
Three thousand participants will be assessed for systemic and local reactions as well as the immune responses. Mene Pangalos, AstraZeneca’s executive vice president, BioPharmaceuticals R&D, promised in a statement that they would work hard to make the vaccine globally available in a fair and equitable manner as rapidly as possible if it demonstrates protection against COVID-19 and gets approved for use.
The Phase III trial of the vaccine will be carried out at 62 study centers. Thirty thousand healthy adults and those having stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from SARS-CoV-2, aged 18 years and older from diverse ethnic, racial, and geographic groups will be recruited in those centers. Based on predicted transmission rates of the virus, centers outside the US were included with sites in Peru and Chile expected to begin recruitment shortly.
Last stage clinical trials of the vaccine are already going on in Brazil, Uk, and South Africa, with more trials to begin in Russia and Japan. Fifty thousand participants will be enrolled altogether. Depending on the rate of infection within the clinical trial communities, the results from the last stage trails are expected by the end of this year, AstraZeneca said.
AZD1222 is a coronavirus vaccine based on the COVID-19 spike protein and adenovirus vaccine vector.
Among the several COVID-19 therapeutics under study, AZD1222 is among the front runners. Researchers from the University of Oxford’s Jenner Institute developed the vaccine AZD1222 in collaboration with colleagues from the University’s Oxford Vaccine Group. The preliminary data regarding the vaccine was published in July 2020 by the researchers from the University of Oxford and AstraZeneca, showing favorable immunogenicity and acceptable safety against the virus. A single dose of vaccine resulted in a four-fold increase in antibodies to the novel coronavirus spike protein in 95% of participants on Day 28 after injection among the 543 participants randomized to AZD1222.
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Development Authority (BARDA) is funding the COVID-19 vaccine trial led by AstraZeneca.