NIH-Led Clinical Trial Evaluates Investigational COVID-19 Vaccine AZD1222

Strategic Insights -

National Institutes of Health announced the initiation of a multi-site, Phase 3 clinical trial evaluating the investigational COVID-19 vaccine candidate AZD1222. The trial aims to enroll approximately 30,000 adult volunteers at 80 sites in the United States to determine if the vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19). The trial is part of Operation Warp Speed and will be implemented in collaboration with the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. The trial will evaluate the safety and efficacy of the vaccine, as well as its ability to prevent severe COVID-19 and reduce the incidence of emergency department visits due to COVID-19.

Key Takeaways:

  • The trial will enroll approximately 30,000 adult volunteers at 80 sites in the United States to evaluate the safety and efficacy of the investigational COVID-19 vaccine candidate AZD1222.
  • The vaccine uses a non-replicating chimpanzee adenovirus to deliver a SARS-CoV-2 spike protein to induce an immune response.
  • The trial is part of Operation Warp Speed and will be implemented in collaboration with the ACTIV public-private partnership.
  • The trial will evaluate the vaccine's ability to prevent symptomatic COVID-19, severe COVID-19, and emergency department visits due to COVID-19.
  • Volunteers will receive either the investigational vaccine or a placebo and will be monitored for safety and reactogenicity.
  • The trial will be conducted in partnership with Oxford University's Jenner Institute and Oxford Vaccine Group, which developed the vaccine.
  • The vaccine has shown promise in early-stage clinical trials, with recent results published in The Lancet indicating its potential efficacy.
  • The trial will involve 20,000 people receiving the investigational vaccine and 10,000 receiving a placebo.
  • The trial is being funded by the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).
  • The trial will be closely monitored by an independent Data and Safety Monitoring Board (DSMB) to ensure the safe and ethical conduct of the study.

Statistics:

  • The trial will enroll approximately 30,000 adult volunteers at 80 sites in the United States.
  • The trial will involve 20,000 people receiving the investigational vaccine and 10,000 receiving a placebo.
  • The trial will assess the vaccine's ability to prevent symptomatic COVID-19, severe COVID-19, and emergency department visits due to COVID-19.
  • Volunteers will be monitored for safety and reactogenicity after receiving the investigational vaccine or placebo.
  • The trial will be conducted over a period of two years, with participants followed for two years after their second vaccination.

Sources:

  • National Institutes of Health
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Biomedical Advanced Research and Development Authority (BARDA)
  • Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership
  • Operation Warp Speed
  • Oxford University's Jenner Institute and Oxford Vaccine Group
  • ClinicalTrials.gov (identifier NCT04516746)