By Rob Preston | July 2020
The US National Institute of Allergy and Infectious Diseases (NIAID) and pharmaceutical company Moderna are seeking 30,000 volunteers for the largest clinical trial to date of their jointly developed COVID-19 vaccine.
Candidates for this Phase 3 trial, to be conducted at an estimated 70 sites across the US, must be at least 18 years old and currently not infected with the coronavirus. Those interested in participating can sign up on the government’s CoVPN Volunteer Screening Registry, an online system developed by Oracle.
Ultimately, as many as five Phase 3 trials—the others not involving Moderna—will be carried out, each of them requiring 30,000 participants. To get there, NIAID will need to enlist at least a million people for consideration.
Results from smaller, earlier-stage clinical tests indicate that the vaccine under evaluation, called mRNA-1273, is safe, thus supporting the more extensive Phase 3 trials, said Dr. Anthony Fauci, director of the NIAID, which is part of the US National Institutes of Health (NIH). “This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last,” Dr. Fauci said.
The current Phase 3 clinical trial is the first to be implemented under Operation Warp Speed, a partnership among multiple US government agencies aimed at accelerating the development, manufacture, and distribution of medical countermeasures to COVID-19. Worldwide, the coronavirus has infected more than 16 million people and contributed to the deaths of more than 650,000 people since it was first identified in the fall of 2019, making it the worst pandemic since the 1918 Spanish Flu.
The cloud-based CoVPN Volunteer Screening Registry, which runs on Oracle Cloud Infrastructure, signed up more than 100,000 vaccine volunteers in less than a week.
On a July 27 online news conference, NIH Director Dr. Francis Collins noted the unprecedented speed of the COVID-19 trial process so far—just 65 days from knowing the sequence of the virus’s RNA to injecting the first patient with the candidate vaccine as part of the 45-person Phase 1 trial, then just four months from Phase 1 to Phase 3.
But he reassured everyone attending the news conference—including a trial participant and conference panelist identified only as Robyn, ostensibly for privacy reasons—that no corners were cut, and that the speed came in part from not losing time between trial phases. “We haven’t sacrificed rigor,” Dr. Collins said. “We have identified some of the down times that happened in between phases, whereas before you had to stop and regroup and figure out how to set up the next network.”
Dr. Stephen Hoge, president of Cambridge, Massachusetts-based pharma company Moderna, described how the Phase 3 trial will work.
Half the participants are injected in the arm with the candidate vaccine, the other half with a placebo. Most patients are then released from their vaccine center within an hour and directed to check in weekly about how they’re feeling and to report any complications.
Within a month, patients come back for a booster shot and then are asked to go about their normal lives, adhering to the standard public health guidance on social distancing, wearing masks, and other preventative measures, before coming back for routine lab tests to determine if they’ve been infected or not.
Key to the trial is determining whether there’s an imbalance between the number of people who were infected with the virus after receiving the placebo versus those who got infected after receiving the vaccine, Dr. Hoge said.
Even as NIAID and Moderna work to recruit the 30,000 people they need for their Phase 3 clinical trial, that trial already has begun, with the first participant given the candidate vaccine at 6:45 a.m. on July 27.
“I’d really encourage people to consider signing up and to share the message with other people you know.”
NIAID recently established CoVPN (COVID-19 Prevention Network) with the goal of registering a million volunteers, a pool that ideally will represent a wide variety of demographics for the multiple Phase 3 trials planned. The cloud-based CoVPN Volunteer Screening Registry, which runs on Oracle Cloud Infrastructure and was developed using the Oracle Application Express (APEX) programming language, signed up more than 100,000 people for consideration in less than a week after going live.
“We’ve made an excellent start with registration, but we have a long way to go,” says Rebecca Laborde, lead product strategist for healthcare and precision medicine at Oracle. “I’d really encourage people to consider signing up and to share the message with other people you know.”
—Margaret Lindquist contributed to this story.
Images: NIH and Oracle
Rob Preston is editorial director in Oracle’s Content Central organization, where he provides insights and analysis on a range of issues important to CIOs and other business technology executives. Rob was previously editor in chief of InformationWeek. You can follow Rob at @robpreston.