From San Diego to St. Louis and Savannah, researchers are preparing to test the Moderna COVID-19 vaccine for 30,000 people, which will 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 a normal appearance. More than 15 million people have been infected with the new coronavirus and more than 600,000 have died worldwide as of Thursday.
The Moderna trial will be held at 87 sites in 30 states and in Washington DC. It is the first large-scale COVID-19 vaccine trial in the United States.
Three of California’s seven test sites are here in San Diego County, with locations in La Jolla, La Mesa, and San Diego. Local sites hope to enroll more than 1,000 people. But to do that, they will need San Diegans to sign up.
“This is an opportunity to help end this pandemic,” said Dr. Stephen Spector, director of the UC San Diego test site.
What do we know about the Moderna vaccine?
There are more than 170 COVID-19 vaccine efforts worldwide. Moderna, a Massachusetts-based biotechnology company, was the first to participate in clinical trials in mid-March and has one of the few vaccines approved 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 new coronavirus. There are two main ways that the immune system can do that. One is through antibodies: Y-shaped proteins that can trap a virus and block infection in cells. The other is through T cells, which can destroy infected cells.
If successful, the Moderna vaccine would be the first of its kind.
On July 14, researchers published findings from a 45-person study of vaccine safety in the New England Journal of Medicine. The vaccine was generally safe; The most common side effects were fatigue, headache, and some pain around the injection site.
In particular, all those who were vaccinated produced antibodies against the virus. In some cases, the level of antibodies in the vaccinated participants was higher than the levels in people who had recovered from COVID-19.
While that is an encouraging sign, the study results do not guarantee that the Moderna vaccine will protect against future infections.
That’s what the next test will test.
How will the test work?
Three sites will run the test 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 offices 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 between 300 and 500 participants each.
The study will be conducted in the same way at all sites. Half of the participants will receive two injections of the Modern vaccine, separated by four weeks. Participants will receive a dose of vaccine designed to stimulate an immune response without triggering strong side effects.
Everyone else will receive a placebo injection that basically contains water with a little salt. Who receives which injection will be randomized.
Participants will then be regularly monitored for COVID-19 symptoms, and those with symptoms will be screened for the coronavirus. The hope is that those who receive the vaccine will be significantly less likely to develop the disease than those in the placebo group.
For researchers to trust that a decent fraction of those vaccinated will be exposed to the virus in their daily lives, these studies must be important, hence the Moderna trial of 30,000 people.
“I am involved in caring for patients in the hospital who really get COVID and have seen several patients die,” said Dr. Scott Overcash, who will lead the trial at the eStudySite location.
“Sometimes, you can start to feel a little helpless as a clinician. I am really excited to start doing something like this, where we hope that we really prevent people from getting serious illnesses. “
Moderna is one of the drug developers selected for Operation Warp Speed, the United States government’s attempt to deliver 300 million doses of a COVID-19 vaccine by January 2021. And while the company’s full trial will last two years, you could get emergency authorization to market a vaccine sooner if provisional results show the vaccine to be effective.
Who is eligible to participate?
You should 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 it can no longer have been infected.
If that’s a bit confusing, it’s because finding the right people for a clinical trial is difficult. You want people who haven’t been infected, otherwise any immune responses you measure could be the result of a 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 would never know if the vaccine worked.
“We don’t want people to be put at greater risk,” said Dr. Denis Tarakjian, who is helping run the trial at M3 Wake Research in San Diego.
Tarakjian lists health workers, supermarket employees, and public transport workers as examples of people who would be a good fit for trial. And it adds that those who are 65 or older, live in a nursing home, or have high blood pressure, obesity, or other pre-existing conditions would also meet the enrollment criteria.
How can I register or get more information?
M3 Wake Research: Text ‘COVID’ at 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 on COVID-19 prevention trials, visit coronaviruspreventionnetwork.org, administered by the National Institutes of Health.
.
