Tracking Resistance and Coronavirus Evolution (TRACE)

Launched on January 20, 2021, the ACTIV Tracking Resistance and Coronavirus Evolution (TRACE) initiative is focused on identifying emerging variants of SARS-CoV-2, the coronavirus that causes COVID-19 disease. To do this, the initiative is surveying new viral variants, assessing vaccine and therapeutic resistance, and evaluating the impact of genetic variation on viral biology and on the clinical approaches for preventing and treating illness. SARS-CoV-2 continues to mutate wherever there are high rates of viral transmission. If the virus continues to circulate at high levels, spontaneous mutations will continually emerge. There also is potential for further transmission of the virus from animals to human, and for the virus to develop resistance to currently effective vaccines and therapeutics.

The ACTIV TRACE initiative aims to prioritize which viral variants should be studied to determine the effectiveness of vaccines and therapeutics currently in late stages of development against these variants; coordinate data sharing; and confirm testing and periodic (e.g. weekly) public reporting of results to allow confident decision making by the U.S. Government (USG), health professionals, and pharmaceutical organizations. ACTIV TRACE is being led by NIH and facilitated by the Foundation for the National Institutes of Health, with participation by the ACTIV public-private partners.

The initiative is developing the infrastructure and processes for monitoring and testing emerging SARS-CoV-2 variants and standardizing, gathering, and sharing variant sequencing data. TRACE is following a 5-step approach to variant monitoring and data sharing:

  1. Monitor global emergence and circulation of SARS-CoV-2 mutations
  2. Cross-reference initial sequence data against database of experimentally or clinically characterized variants
  3. Characterize prioritized variants in vitro (outside the animal) through critical-path assays
  4. Characterize prioritized variants in vivo (inside the animal) through critical-path assays
  5. Rapidly share activity data with the ACTIV membership and scientific community

Currently available information on viral variant characteristics and overviews of preclinical assays used to test them can be found on the Variant Therapeutic Data Summary within the NCATS OpenData Portal.