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COVID-19 Vaccine


Title A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Therapeutic Area Covid-19
Principal Investigator Brian Chow, MD
Min Age 18 Years
Gender Any
Contact Vidya Iyer, MD, CCRP
617-636-0186
viyer1@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04516746

Overview

This study is being done to see if a vaccine that is being developed to prevent people from getting sick with COVID-19 is safe and effective and also to see how well it is tolerated. It involves both vaccine and a placebo (which looks like the vaccine but does not contain any actual vaccine).

Study Details

Inclusion Criteria

  • Increased risk of COVID-19 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure.
  • Medically stable, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrollment, or according to the judgment of the investigator.

Exclusion Criteria

  • History of laboratory-confirmed SARS-CoV-2 infection.
  • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, recurrent severe infections and use of immunosuppressant medication within the past 6 months as judged by the Investigator (mild/moderate well-controlled comorbidities are allowed).
  • Receipt of, or planned receipt of investigational products indicated for the treatment or prevention of SARS-CoV-2 or COVID-19

Study Requirements

This study will last for 24 months with at least nine study visits. If you take part, you will receive a pre-dose nasal swap, and a shot of either the vaccine or a placebo twice: once on Day 1 and a booster shot on Day 29. A placebo will look like the vaccine but will not have any active vaccine in it.  After the shots you will have blood drawn (about one teaspoon) at least seven times for the next 24 months to assess your immune system’s (how your body fights off the virus) response.