As researchers from across the globe race to find a vaccine for the coronavirus, the Medical University of South Carolina has entered as a key player in that fight. Along with AstraZeneca and IQVIA, MUSC was selected be part of a Phase III trial of a vaccine that has shown promise in battling COVID-19.
“The science behind it looks good,” said MUSC emergency medicine physician Gary Headden, M.D., who will be leading the trial. “So, I’d say I’m optimistic.”
MUSC and Charleston will be part of the first wave of locations across the United States to test the vaccine. In total, manufacturers and researchers hope to enroll and collect data on 30,000 people across 20 cities in the U.S., with as many as 1,500 of those being from right here in Charleston.
For context: Once a pharmaceutical company thinks it has a promising vaccine on its hands, it begins clinical trials. According to the U.S. Food and Drug Administration, these trials consist of three phases:
- Phase 1, also referred to as initial human studies, is performed on small groups and focused on safety and the recipient’s immune response to the vaccine.
- Phase 2, which are usually administered on hundreds of people, is still focused on safety and fine-tuning the dosage and treatment regimen required.
- Phase 3 typically enrolls thousands of individuals and focuses on the safety and efficacy (how well it works) in a population.
If successful, the manufacturer can then submit an application to the FDA for approval.
Because of the unique world we’re living in, the U.S. government has implemented “Operation Warp Speed,” which aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021. In other words, a process that often takes years, is being compressed into mere months. To facilitate this process, the government is speeding up all aspects that can safely be sped up and is pumping billions of dollars into the pharmaceutical industry. AstraZeneca, the company that has manufactured the vaccine being tested at MUSC, received $1.2 billion alone.
According to Amanda Cameron, Trial Innovation Network manager at MUSC and a key figure in bringing the trial to the university, even with Operation Warp Speed in play, this is one of few Phase III vaccine trials out there.
“For us to get to bring trial here to MUSC is incredible, but the fact that it’s one that researchers are optimistic about is even more exciting,” she said.
Recently, Russia claimed to have a vaccine ready. U.S. researchers believe it has effectively only cleared Phase I, so to roll it out so quickly could prove to be reckless, Headden said.
This week, MUSC will go live with a webpage, officially opening the trial to applicants. The hopes are that soon thereafter, the study’ first patients will be seen at the Clinical Sciences Building on MUSC’s downtown campus. Several hundred have already expressed interest in participation, and MUSC clinical research manager Ashley Warden said the team would love to get as many people involved as possible.
“This is a really important research opportunity,” Warden said. “We need to have a therapy that can bring this pandemic into control. It would be best that those that participate in this trial are representative of our region.”
The trial – which will be double-blind, randomized and placebo-controlled in a 2:1 ratio, meaning that for every two people who get the active vaccine, one will get the placebo – will require the participants to come in at Day 1 and Day 29 to receive their vaccines or the placebo.
Researchers and doctors hope each of these two visits will last about 90 minutes, during which time the participants will undergo a physical examination that includes having their medical histories reviewed, blood drawn for testing and a nasal swab test for COVID-19. The vaccine will then be administered.
All subjects will be monitored over a period of two years. During this time, those who show any signs of illness that could be due to COVID-19 will undergo additional testing. Compensation will be provided for participants’ time.
“This is a big study with an aggressive time frame, which is expected of a trial of this importance,” Headden said. “As for the science behind it, it’s totally solid. Put it this way: I would let my family take this vaccine.”
To learn more about the trial or to enroll, visit https://research.musc.edu/clinical-trials/coronavirus-clinical-trials.