Development of COVID-19 Vaccine AZD1222 Expands to Phase 3 Clinical Trials in the US

The development of the coronavirus disease 2019 (COVID-19) vaccine AZD1222 has expanded into a phase 3 trial that is enrolling 30,000 adults aged 18 years or older to assess its safety, efficacy, and immunogenicity.

AZD1222, which was co-invented by the University of Oxford and Vaccitech, uses a replication-deficient chimpanzee viral vector based on a weakened common cold virus (adenovirus). This virus contains the genetic material of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus spike protein.

Upon vaccination with AZD1222, the surface spike protein is created, which prepares the immune system against SARS-CoV-2 if it appears in the body in the future.

The US trial investigating AZD1222 is a randomized, double-blind, placebo-controlled study called D8110C00001. It is funded by Biomedical Advanced Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) and is being led by AstraZeneca.

AstraZeneca had received 1 billion dollars from BARDA for the development, production, and delivery of the vaccine in May 2020, and the current phase 3 trial is a part of that original funding agreement. The COVID-19 Prevention Network (CoVPN), supported by the NIAID, will participate in the trial as well.

“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,” said Mene Pangalos, PhD, executive vice president of BioPharmaceuticals R&D, in a press release.

In the United States, trial centers have begun to enroll adults of diverse racial, ethnic, and geographic backgrounds who are healthy or have stable underlying medical conditions, such as HIV, as well as those who are at an increased risk of SARS-CoV-2 due to their medical conditions. There are also centers outside of the United States that will be included in the study based on the predicted transmission of the area, such as sites in Peru and Chile, which are planned to begin recruiting patients soon.

In D8110C00001, participants will receive 2 doses of either AZD1222 or a saline control. The results will allow the researchers to assess the efficacy and safety of the vaccine in all of the study’s participants, as well as the local and systemic reactions and immune responses in 3000 of those participants.

With late-stage clinical trials assessing AZD1222 underway in the United Kingdom, Brazil, and South Africa, as well as trials set to begin in Japan and Russia, the total number of participants in trials assessing AZD1222 globally is planned to be 50,000.

In July 2020, interim results from the phase 1/2 COV001 trial assessing AZD1222 were published in The Lancet, demonstrating the vaccine to be tolerated by patients while also successfully producing immune responses against SARS-CoV-2 in all of the participants. Results from the late-stage clinical trials that are currently underway internationally are expected to be available later this year.

AstraZeneca has recently made supply agreements with Russia, South Korea, Japan, China, Latin America, and Brazil, bringing the current global demand for the vaccine to 3 billion doses. However, the company has stated that they plan to continue to work with governments around the world to ensure access if the current phase 3 trails are successful.

REFERENCE

Development of COVID-19 Vaccine AZD1222 Expands Into US Phase III Clinical Trial Across All Adult Age Groups. Wimington, DE: AstraZeneca; August 31, 2020. businesswire.com/news/home/20200831005737/en. Accessed September 1, 2020.