UC San Diego to take part in massive COVID-19 vaccine trial and seeks sign-ups
From La Jolla to St. Louis to Savannah, researchers are gearing up for Moderna’s 30,000-person COVID-19 vaccine trial, set to begin Monday, July 27.
The hope is 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.
Moderna’s trial, the first large-scale COVID-19 vaccine trial in the United States, will take place at 87 sites across 30 states and Washington, D.C.
Three sites are in San Diego County: UC San Diego in La Jolla, M3 Wake Research in San Diego and eStudySite in La Mesa. Those sites expect to enroll a total of more than 1,000 people. To do that, they’ll need area residents 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.
This study is different from a previously announced trial of plasma therapy at UCSD that began taking sign-ups July 14. That trial aims to answer the question of whether the treatment, which can temporarily transfer immunity from the blood of COVID-19 survivors to those at risk of getting infected, could prevent the disease.
UC San Diego is looking for volunteers for a trial of an experimental treatment that could temporarily transfer immunity from the blood of COVID-19 survivors to those at risk of getting infected.
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 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 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 found to be safe overall; the most common side effects were fatigue, headache and a bit of soreness around the injection site.
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.
However, 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?
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 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.
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. Though 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?
Participants 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 they live or work.
They can’t already have been infected. The clinical trial needs people who haven’t been infected, otherwise any immune response measured could be the result of past infection and have nothing to do with the vaccine.
But it also doesn’t want people who will never be exposed to the virus, because then doctors would 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.
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. Those who are 65 or older, live in a nursing home or have high blood pressure, obesity or other conditions also would meet the enrollment criteria.
To sign up or learn more, contact the local trial locations:
UCSD: Call (619) 543-8089 or visit medschool.ucsd.edu/research/actri/clinical/Pages/COVID-19-Prevention-Network-Study.aspx.
M3 Wake Research: Text “COVID” to (619) 330-1172.
eStudySite: Call (619) 704-2750 or visit estudysite.com.
For more information about COVID-19 prevention trials, visit coronaviruspreventionnetwork.org, run by the National Institutes of Health.
La Jolla Light staff contributed to this report. ◆
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