A multi-site, Phase 3 clinical trial evaluating an investigational COVID-19 vaccine known as AZD1222 has begun, according to a press release from the National Institutes of Health (NIH). The trial will enroll approximately 30,000 adult volunteers at 80 sites in the United States to evaluate if the candidate vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19).
The United Kingdom-based global biopharmaceutical company AstraZeneca is leading the trial as regulatory sponsor. The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response, are providing funding support for the trial.
“Safe and effective vaccines will be essential to meet the global need for widespread protection against COVID-19,” said NIAID Director Anthony S. Fauci, MD. “Positive results from preclinical research led by NIH scientists supported the rapid development of this vaccine candidate, which has also showed promise in early-stage clinical trials.”
The Phase 3 trial is being implemented as part of Operation Warp Speed, a multi-agency collaboration led by the HHS that aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership also guided the development of the trial protocol to ensure a coordinated approach across multiple vaccine efficacy trials. NIH experts have emphasized the importance of a harmonized process to generate data for multiple investigational vaccines in parallel to assess the relative effectiveness of each.
The trial primarily is designed to determine if AZD1222 can prevent symptomatic COVID-19 after two doses. The trial also will evaluate if the vaccine candidate can prevent SARS-CoV-2 infection regardless of symptoms and if it can prevent severe COVID-19. It also will assess if the experimental vaccine can reduce the incidence of emergency department visits due to COVID-19.
