July 17, 2020 -- Stella Sexton is one of those good citizens who helps out whenever she can. "I'm a blood donor, O-negative," says the 41-year-old property manager and mother of two in Lancaster County, PA. After her second baby, she donated extra breast milk to milk banks. When her kids' school is in session, she helps out there, too.
So her decision to join a clinical trial for a COVID-19 vaccine was predictable. "I just thought, 'I have to help,''' she says. She was in an early vaccine trial, called a phase I trial, to test its safety.
To find them, the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) has launched a new clinical trials network. Called the COVID-19 Prevention Trials Network (CoVPN), it merges four clinical trial networks across the country.
"We are looking to recruit millions of people into this registry by September," says Jim Kublin, MD, executive director of the operations program of CoVPN, coordinated by the Fred Hutchinson Cancer Research Center in Seattle.
Attracting millions to sign up at the CoVPN website will help ensure that researchers get the numbers they need, as some won't qualify. Researchers expect to roll out five vaccine trials before the end of the year, Kublin says. They need about 30,000 people for each.
As of July 17, more than 3.59 million cases of COVID-19 have been diagnosed in the U.S., and more than 138,500 people have died.
Details on Volunteering
On the website, volunteers complete a screening registry, which takes about 15 minutes. They are asked for personal contact information, demographics on where they live, height, weight, race, ethnicity, occupation, details about exposure to COVID-19, and data on preexisting conditions, Kublin says.
It's important to attract a broad cross-section of people, he says, not just young and healthy people. "The trials are not just to evaluate the vaccine effectiveness, but also the effect on a person's health," he says.
Once completed, survey information is given to a study site closest to a volunteer's location. Some volunteers may be contacted very soon, Kublin says, while others may be contacted later or not at all. Among the common reasons volunteers would be disqualified, he says, are being under age 18, having a history of allergic reactions to vaccines, or having a condition that weakens their immune system.
Volunteers will have a detailed discussion with the study staff so they can make an informed decision about joining.
Most of the studies will require volunteers to visit the research site 10 or more times over 1 or 2 years. Every study involves getting shots or IVs. Some volunteers will get a vaccine, and others will get a placebo. None of these studies involve exposing volunteers to the virus that causes COVID-19.
Participants receive payments for their time and inconvenience. The payments vary, depending on the number of visits and where they’re located, as the cost of living varies by region.
"This is an unprecedented moment in our history, and it requires all of us to get involved, especially those who may be vulnerable to infection and disease," Kublin says. COVID-19 disproportionately affects people of color and older adults, he says, so it's important they be included in the trials. The vaccines have been tested thoroughly to make sure they’re safe, he says.
The much larger trials are crucial to know how well they work.
‘You Feel Like You Are Taking Action’
Zoe Evans, 49, a high school principal in Bowdon, GA, began thinking about volunteering in March. That’s when she first heard that Emory University in Atlanta, about 60 miles away, was doing a phase I vaccine trial. "I looked into it, but Emory had all the 18- to 55-year-olds they needed [for that one]."
Now, she has signed up through the CoVPN site. "I had dual emotions," she says. "I wanted to help move this through quicker. I want a vaccine to come about. I could help science, but I could also help myself at the same time. It was really a little bit of both."
Another thing that weighed into her decision: Her 23-year-old daughter tested positive in late May. She's recovered, although her sense of smell is not yet 100% back, she says.
For Shelly Groves, a 56-year-old Atlanta pet sitter, the decision to join a phase I trial at Emory was simple. "We need a vaccine, and I knew I was healthy." She previously took part in a clinical trial to see if dog owners can pass on an infectious illness like influenza to their dog, and if the dog then becomes a carrier and passes the illness back to the owner. (She hasn't heard the results yet.) It was a good experience, so she says she felt comfortable joining another.
She has had two shots of the Moderna vaccine now being tested, the last one May 14. It is a messenger RNA vaccine. Besides a slightly sore arm, she says she had short-lived joint pain after both shots -- one time the knees, another the shoulders -- but it didn't affect her daily routine. Her advice: "It's safe. You're helping your fellow man."
Stacey Lapp, 51, a senior research specialist at Emory University, has signed up, too. He researched the anthrax vaccine and took part in an HIV vaccine trial. "I'm a scientist, and I want to see things move forward,'' he says. He’s not worried about side effects, he says.
Sexton says that volunteering has been "a wonderful experience." She praises study administrators for always putting her health and safety first. "It's made me feel confident there are a lot of smart, confident people working [on the vaccines] behind the scenes." After the first shot, she had mild fatigue but still exercised, she says. She is helping test the Inovio vaccine, which is given with a handheld smart device that uses a brief electrical pulse to open small pores in the skin to deliver the DNA vaccine. "It doesn't hurt, but I wouldn't do it for fun," she says.
She will be paid $1,200 over the course of her 52-week participation. Groves will get $705. As Sexton says, it isn't about the money. "I would do it for free. Participating in a vaccine trial is really empowering. You feel like you are taking action and doing something to help solve the crisis and get the world back to normal."