Development Of COVID-19 Vaccine AZD1222 Expands Into US Phase III Clinical Trial Across All Adult Age Groups
AZD1222 development expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity.1)
The US 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, Executive Vice President, BioPharmaceuticals R&D, said: "We are pleased that AZD1222 demonstrated safety and immunogenicity across all adult age groups and are proud to be collaborating with BARDA and NIAID to accelerate the development of this vaccine. Should clinical trials demonstrate the vaccine protects against COVID-19 disease and is approved for use, we will work hard to make it globally 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.
AstraZeneca continues to engage with governments, multilateral organisations and partners around the world to ensure broad and equitable access to the vaccine, should clinical trials prove successful. Recent supply announcements with Russia, South Korea, Japan, China, Latin America and Brazil take the global supply capacity towards three billion doses of the vaccine.
The Company today issued a commitment to the highest safety standards and to broad and equitable access, reiterating its core values to "follow the science" and "put patients first".
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.
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.
In May 2020, AstraZeneca received support of more than $1bn from BARDA for the development, production and delivery of the vaccine. The Phase III D8110C00001 trial is part of this funding agreement.