From San Diego to St. Louis to Savannah, researchers are gearing up for Moderna’s 30,000-person COVID-19 vaccine trial, set to begin Monday.
Many hope that a safe and effective vaccine will control the spread of the worst pandemic in a century and bring life back to some semblance of normalcy. More than 15 million people have been infected with the novel coronavirus and over 600,000 have died worldwide as of Thursday.
Moderna’s trial will take place at 87 sites across 30 states and Washington D.C. It’s the first large-scale COVID-19 vaccine trial in the United States.
Three of California’s seven trial sites are here in San Diego County, with locations in La Jolla, La Mesa and San Diego. The local sites expect to enroll more than 1,000 people. But to do that, they’ll need San Diegans to sign up.
“This is an opportunity to make a contribution to ending this pandemic,” said Dr. Stephen Spector, director of the UC San Diego trial site.
What do we know about Moderna’s vaccine?
There are more than 170 COVID-19 vaccine efforts worldwide. Moderna, a biotech company headquartered in Massachusetts, was the first to enter clinical trials in mid-March and has one of the few vaccines cleared for a large-scale study.
The company’s vaccine uses a molecule called messenger RNA to teach the body to target the surface of the novel coronavirus. There are two main ways the immune system can do that. One is through antibodies — Y-shaped proteins that can grab onto a virus and block it from infecting cells. The other is through T cells, which can destroy infected cells.
If successful, Moderna’s vaccine would be the first-ever of its kind.
On July 14, researchers released findings from a 45-person study of the vaccine’s safety in the New England Journal of Medicine. The vaccine was safe overall; the most common side effects were fatigue, headache and a bit of soreness around the injection site.
Notably, everyone who was vaccinated produced antibodies against the virus. In some cases, the level of antibodies in vaccinated participants was higher than levels in people who had recovered from COVID-19.
While that’s an encouraging sign, the study’s results are no guarantee that Moderna’s vaccine protects against future infection.
That’s what the upcoming trial will test.
How will the trial work?
Three sites will run the trial in San Diego County: UC San Diego in La Jolla, M3 Wake Research in San Diego and eStudySite in La Mesa.
Both M3 Wake Research and eStudySite are organizations that provide clinical research facilities and services. M3 Wake Research has locations in seven states, and eStudySite was founded in San Diego in 1999.
UCSD aims to enroll 500 participants. M3 Wake Research and eStudySite say they could enroll about 300 to 500 participants apiece.
The study will be conducted in the same way at all sites. Half of participants will get two injections of the Moderna vaccine, spaced four weeks apart. Participants will get a vaccine dose designed to stimulate an immune response without triggering strong side effects.
Everyone else will get a placebo injection that basically contains water with a bit of salt. Who gets which injection will be assigned at random.
Participants will then be monitored regularly for COVID-19 symptoms, and those with symptoms will be tested for the coronavirus. The hope is that those who get the vaccine will be significantly less likely to develop the disease than those in the placebo group.
For researchers to be confident that a decent fraction of those vaccinated will get exposed to the virus in their day-to-day lives, these studies need to be big — hence Moderna’s 30,000-person trial.
“I’m involved in taking care of patients in the hospital who actually get bad COVID disease and have seen multiple patients die from it,” said Dr. Scott Overcash, who will direct the trial at the eStudySite location.
“Sometimes, you can start to feel a bit powerless as a clinician. I’m just really excited to start doing something like this where hopefully we actually prevent people from getting severe disease.”
Moderna is one of the drug developers selected for Operation Warp Speed, the U.S. government’s bid to deliver 300 million doses of a COVID-19 vaccine by January 2021. And while the company’s full trial will last two years, it could get emergency authorization to market a vaccine sooner if interim results show that the vaccine is effective.
Who’s eligible to participate?
You’ll need to be in a high-risk group for COVID-19 or have a higher-than-average chance of being exposed to the virus based on where you live or work.
But you can’t have already been infected.
If that’s a bit confusing, it’s because finding the right people for a clinical trial is tricky. You want people who haven’t been infected, otherwise any immune response you measure could be the result of past infection and have nothing to do with the vaccine.
But you also don’t want people who will never be exposed to the virus, because then you’d never know if the vaccine worked.
“We don’t want individuals to put themselves at increased risk,” said Dr. Denis Tarakjian, who is helping run the trial at M3 Wake Research in San Diego.
Tarakjian lists health care workers, grocery store employees and public transportation workers as examples of people who would be a good fit for the trial. And he adds that those who are 65 or older, live in a nursing home, or have high blood pressure, obesity or other preexisting conditions would also meet the enrollment criteria.
How can I sign up or learn more?
M3 Wake Research: Text ‘COVID’ to 619-330-1172
eStudySite: Call 619-704-2750 or visit estudysite.com
UCSD: Call 619-543-8089 or visit medschool.ucsd.edu/research/actri/clinical/Pages/COVID-19-Prevention-Network-Study.aspx
For more information about COVID-19 prevention trials, visit coronaviruspreventionnetwork.org, run by the National Institutes of Health