By Allison Proffitt

May 11, 2020 | Earlier last week week, Adaptive Biotechnologies in partnership with Microsoft began enrolling a virtual clinical study, ImmuneRACE, to rapidly map and measure the immune response to the COVID-19 virus. The study is now enrolling individuals across the country who have COVID-19, have recovered, or have been exposed. The data gathered in the study will be released freely.

Adaptive Biotechnologies offers quantitative immunosequencing assays to reveal the breadth and depth of the immune repertoire for diagnosis and cancer tracking. In the ImmuneRACE study, samples will be used to look for changes and markers in immune response that would help indicate who has a SARS-CoV-2 infection now or in the past. The company uses multiplex PCR amplification, high-throughput sequencing and sophisticated bioinformatics to tease out what an immune response to the SARS-CoV-2 virus looks like specifically.

“With the platform that we have at Adaptive Biotechnologies, what we’re able to do is extract DNA from anyone and look at the genomic DNA from T cells and B cells,” explained Lance Baldo, Chief Medical Officer at Adaptive Biotechnologies. “Those T cells and B cells are ultimately going to be specific for something. In the case of SARS-CoV-2 or COVID-19, they’re going to be the T cell receptor sequences or B cell receptor sequences of COVID-19. That’s our fundamental platform. We use that platform to find better or novel diagnostics or even identify therapeutics.”

Read more about the diagnostic options at Diagnostics World.

Open Enrollment

The ImmuneRACE trial seeks to characterize immune response from 1,000 participants in more than 20 U.S. metropolitan areas who either have COVID-19, have recently recovered from COVID-19, or were exposed to someone diagnosed with COVID-19. Disease status and exposure will be self-reported.

The trial is wholly virtual. Participants between the ages of 18 and 89 begin with an online questionnaire at the ImmuneRACE site that asks eligibility and consent questions. There are no exclusionary health conditions. For participants who are accepted into the trial, LabCorp, through its Covance drug development business, will manage the collection of blood samples and nose/throat swabs from participants. Participants will submit sample at least once but can opt in for up to four additional blood draws and questionnaires.

“We’re looking to over-enroll in cohorts that we think are going to have more informative information to share with the world. We’re looking for more in the active and more in the recovered [cohorts] and fewer in the exposed [cohort]. We’re also trying to get not only subjects in those three groups, but we want really good geographic diversity and… really good—hopefully—ethnic diversity as well,” Baldo told Clinical Research News. “As you’ve been aware from the literature, it seems there may be a couple of strains at least in our country... If it hasn’t already mutated, it may soon. So we’re making sure we have some really good representation from across the country.”

Data Gathered, Data Shared

Baldo is hopeful the study will meet enrollment in less than the goal of ten weeks. Interested participants already number in the “triple digits” he said.

In addition to data collected from ImmuneRACE study participants, Adaptive Biotechnologies and Microsoft are also gathering retrospective data from all over the world thanks to partnerships with healthcare organizations.

“They have, in some cases, thousands of samples that were luckily properly collected to preserve the T cell portion of the blood specimen,” Baldo said of partners in Spain, Italy, and across the US. “We’re going to augment our prospective 1,000 with probably multiple thousand more that are going to come from all over the world. That combination, we think, is going to be really meaningful.”

Deidentified data from both datasets will be released to researchers; Baldo expects the first dataset to be made public next month.

“Our attitude is that whether we have 100 or 400 or 500 or frankly 1,000 subjects sequenced at that point, time is not on our side here. We need to make data available sooner rather than later. We’re targeting June for an initial release of the data and we’ll just add to it over time.”

Machine Learning

Data will likely be shared on a modified version of Adaptive’s immunoSEQ Analyzer tool, part of the bioinformatics and visualization platform that supports the immunoSEQ Assay. The data will be hosted on Microsoft Azure.

Since 2018, Adaptive has had a partnership with Microsoft to use machine learning to map the immune system response to many different diseases, including infectious diseases, autoimmune disorders and cancer. The most developed work so far has been for Adaptive’s immunoSEQ Dx diagnostic assay for Lyme disease. In March, the companies announced an expansion of their existing partnership to study COVID-19.

“We took that existing relationships and the existing ways of working and the existing tools and technologies which were already being developed in infectious disease… We were able to take all those learnings and apply them to what we’re doing with COVID-19,” Baldo said. “The good news from the adaptive immune system is that it doesn’t make a distinction—from a T cell perspective—between bacteria and a virus or anything else. We’re able to use that same approach that we used with Lyme disease with COVID-19. That’s how we were able to put this deal together in about 24 hours.”