Trial enrolling up to 30,000 adults aged 18 years or over to assess safety, efficacy and immunogenicity of AZD1222 for the prevention of COVID-19
AZD1222 supported by safety and immunogenicity across all adult age groups
Vaccitech Ltd, a clinical-stage biopharmaceutical company developing immunotherapies to treat and prevent infectious diseases and cancer, announces that the development of AstraZeneca’s AZD1222 vaccine has expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity. AZD1222 was co-invented by Vaccitech and Oxford University’s Jenner Institute.
The US Phase III trial, called D8110C00001, is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial.
Mene Pangalos, AstraZeneca Executive Vice President, BioPharmaceuticals R&D, said: “We are proud to be collaborating with BARDA and NIAID to accelerate the development of AZD1222. The speed at which this new vaccine has advanced into global late-stage clinical trials is testament to the ground-breaking research and tireless commitment of our partners and teams. Should clinical trials demonstrate the vaccine protects against COVID-19 disease and it is approved for use, we will work hard to make it available in a fair and equitable manner as rapidly as possible.”
Trial centres across the US are recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus. Centres outside the US are included based on predicted transmission rates of the virus and sites in Peru and Chile are planned to initiate recruitment shortly.
Participants are being randomised to receive two doses of either AZD1222 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control. The trial is assessing efficacy and safety of the vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.
Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa and trials are planned to start in Japan and Russia. These trials, together with the US Phase III clinical trial will enrol up to 50,000 participants globally. Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the clinical trial communities.
In July 2020, interim results from the ongoing Phase I/II COV001 trial were published in The Lancet and showed AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.
To read the full AstraZeneca announcement, please follow the link here
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
D8110C00001 is a Phase III randomised, double-blind, placebo-controlled multicentre study assessing the safety, efficacy, and immunogenicity of AZD1222 compared to placebo for the prevention of COVID-19, in up to 30,000 participants across approximately 100 trial centres in and outside the US. Trial participants aged 18 years or over who are healthy or have medically stable chronic diseases, and are at increased risk for being exposed to the SARS-CoV-2 virus and COVID-19 will be randomised in a 2:1 ratio to receive two intramuscular doses of either 5 x1010 viral particles of AZD1222 or saline placebo four weeks apart, on day one and 29. Randomisation will be stratified by age (≥ 18 to < 65 years, and ≥ 65 years), with at least 25% of participants to be enrolled in the older age range. Individuals interested in participating in the Phase III D8110C00001 vaccine trial can visit https://www.c19vaccinestudy.com or www.CoVPN.org websites for more information.