Esther Aviles wants to help her special-needs students and her nine nieces and nephews.
Joseph Shilisky believes the world needs ordinary people like him to step up.
Robert Huebner likes to be among the first, whether it’s the first to try a new computer game, a new restaurant, or – now – a new vaccine.
All three are among the early volunteers in clinical trials to test potential COVID-19 vaccines. Vaccine developers have already shown basic safety, with no severe reactions in early trials. And they’ve shown their candidate vaccines trigger the kind of immune response they want to see.
Race to the vaccine
The first of an occasional USA TODAY series about efforts to rapidly develop and deliver a vaccine against the coronavirus.
But to meet scientific standards of safety and effectiveness, each candidate has to be tested in thousands of people, most of whom will get two shots apiece of a vaccine that’s still unproven.
Three of these Phase 3 trials have started already in the U.S.: one by Pfizer and BioNTech; another by AstraZeneca paired with Oxford University; and the third by biotech firm Moderna, which got a development assist from the U.S. government.
If all seven candidate vaccines now funded by the federal government make it to Phase 3, they will need a combined total of at least 210,000 volunteers, half receiving active vaccine and half a placebo.
The participants won’t know whether they got the actual vaccine until their trial ends in about two years. In the meantime, they are left wondering whether their lack of a sore arm or fever means they received the placebo or just got lucky.
Some Phase 3 volunteers are eager to get the active vaccine.
Raymond Grosswirth, 71, of New York state hopes to be able to protect his wife of 26 years. Two years ago, she was in the hospital for months with pneumonia that turned septic, and he doesn’t want her catching COVID-19.
Dusta Eisenman doesn’t care. She just likes the idea of participating in a trial with the potential to help hundreds of millions of people. “If I got the placebo, then I will go and get the actual shot when ready,” said Eisenman, 44, of San Jose, California.
Vaccination is the only way to stop a pandemic like this – with a virus that is extremely contagious and infectious before symptoms show up, if they ever do.
But it’s proving a challenge to find enough volunteers.
While the first few trials may be OK, with Moderna reportedly having signed up 13,000 volunteers since late July, many more people will be needed for the others.
Dr. Jim Kublin, who runs a federally funded COVID-19 clinical trial registry at the Fred Hutchinson Cancer Research Center in Seattle, said he ha hoped to have 1 million people sign up by the end of August. Instead, because of a late start on their advertising campaign, only about 360,000 have volunteered so far.
Not all those volunteers will qualify. Some, because they don’t live near trial sites. Others because the investigators are looking to overrepresent those most vulnerable to the virus: people who are older, nonwhite, or have one or more of a host of medical conditions, including diabetes, kidney disease and lung disease.
Kublin, an infectious disease doctor and researcher, said it’s important to get as many people of all ages and health status into the database as possible to improve the algorithms on who best to include in the trials.
He wants more people to volunteer and sees the trials as “a call to duty and a call to contribute to this national effort that is really the only way we’re going to solve this problem.”
Jarelle Marshall
Jarelle Marshall, 37, of Cincinnati said his 14-year-old son was a big part of his motivation to volunteer. “I always tell my son that what matters is what you do when people aren’t looking,” he said.
That’s why when a friend asked him to participate in the trial, the information technology consultant didn’t hesitate long.
First, he asked for more information, which he forwarded to another friend, a doctor, to ask for advice. The doctor sent him a long text, telling him what to expect in the trial and why volunteers were important.
Then came the kicker: Researchers need African-Americans like you.
Black and Latino people have been particularly hard-hit by the virus, and the companies have pledged to include enough in the trials that they can be sure the vaccine will work just as well for people of color as for whites.
“I figured my risk was fairly low and that I would give it a shot,” said Marshall, pun intended. “I jumped in the car.”
Less than an hour after the initial request, Marshall became the first person to volunteer for a trial run by UC Health and the University of Cincinnati College of Medicine.
He had only a sore arm after the injection – which he acknowledges might have been psychosomatic, because he hates needles so much that he usually avoids an annual flu shot.
Want to volunteer for a clinical trial?
For the general trial registry: https://coronavirus
preventionnetwork.org
• Moderna’s trial: https://www.modernatx.com/
• Pfizer and BioNTech’s trial: https://www.covidvaccinestudy.com/
• Velocity Clinical Research (which has 8 research sites around the country): https://www.velocityclinical
research.com
• UC Health (in the Cincinnati area): https://www.uchealth.com/en/covid-19/research/covid-19-clinical-trials
But he was stunned by the polarized reaction of his friends and acquaintances.
He sees volunteering as a selfless act to help everyone on the planet. Others criticized him, saying he did it for the money – just $500 over two years, he said, chuckling at the thought. Or wondering why he would bother.
“I thought it would be widely accepted that ‘Hey, we need people to test it and make sure it’s safe for everybody so we can all get back to normal,'” he said. “I’m sure everybody wants to have a burger, or lunch, without having to wear a mask.”
Some also were worried he might get the virus from the vaccine. He carefully explained that these newer vaccines don’t include the whole virus, so they can’t make you sick.
Marshall’s mother lives with his grandmother. They recently celebrated her 89th birthday. So he’s not taking a lot of chances. He wears a mask when he’s around them, and at business meetings that started up again six to eight weeks ago. As a consultant, he travels a lot to help banks, schools and hospitals cope with IT challenges.
Meetings are now masked or held via video-chat. He drives when he can. He wears a mask when he has to fly.
And then there’s his son, who he hopes will get to enjoy a full high school experience. That’s why, as soon as Marshall got the okay from someone he trusted, he headed out, ready to roll up his sleeve.
“Hopefully, it’ll help somebody out, whether I got the actual vaccine or the placebo,” he said. “The end goal is to help along the study. That’s where I’m at.”
Dusta Eisenman
Dusta Eisenman, 44, and her husband, Jeff, 45, both signed up. They strongly support science and wanted to show their children they were doing something to help end the pandemic that has been so disruptive of their lives.
Eisenman, a nurse in the pediatric department of Kaiser Permanente Santa Clara Medical Center, said studying online was challenging last spring for their three children, ages 16, 14 and 11. High school has gone virtual again for the fall, and the middle school has been taking a “wait and see” approach.
Eisenman’s oldest is a cheerleader and devastated by the cancellation of the fall football season. Her son is training for a cross-country team that may not compete this year. And her youngest will lose a season of competitive dance.
“There are a lot of milestones my kids are missing out on,” Eisenman said.
So she volunteers where she can, “trying to do my small part to help out, so my kids see ‘I’m doing my best, guys.'”
Jeff has been working from home, and with real estate prices in the Bay Area being what they are, there’s not a lot of extra room. “We’ve been having to use the backyard and every other space,” Eisenman said. “It’s been tough.”
Still, she figures they’re luckier than most people, which is why she volunteered for the trial.
Interviewed the day she got her first shot, she was a little tentative, because the vaccine has not yet been approved for general use. “It’s probably pretty normal to be slightly hesitant about something so new,” she said. But she was comforted by early trial results showing no serious harms. And she was willing to take the risk.
“I think we’re fortunate to live in this country and have vaccine at our disposal. A lot of people take it for granted,” Eisenman said.
Robert Huebner
“Be the first on your block,” was all the motivation Robert Huebner of Glendale, California, needed to volunteer.
The father of two girls, ages 8 and 10, Huebner, 50, has been very careful during the pandemic, wearing a mask all the time, working from home, playing it safe.
He was worried during the selection process for the trial that he wouldn’t be chosen because he had been too careful. Organizers want participants to be at some risk of infection so they can determine whether their candidate vaccine is protective.
But he made the cut.
Huebner still goes to restaurants – as long as there’s an outdoor patio. He and his wife like to be among the first to try new dining spots, and they’ve tried a few new ones amid the pandemic, always sitting outside.
Huebner quit his “dream job” at Disney when he was placed on long-term furlough this spring and now works as a game designer.
He and his wife, a lawyer who also works from home, have made other adjustments during the pandemic, too, like giving up on overseas travel and foregoing movies. “I do really miss sitting in a dark theater,” he said.
Despite their caution, Huebner remains nervous about catching the virus. No one close to him has had COVID-19, but even if the odds of complications are low, he’s concerned by reports of severe reactions.
He wanted to spike a bit of a fever after the shot – to suggest that he’d gotten the active vaccine. But he had no reaction at all. “I’m still holding out hope,” he said. Roughly half those who got the vaccine in early trials had no side effects.
If he got the placebo, he won’t know for two years, can’t get another vaccine in the meantime, and could be more vulnerable than those who didn’t volunteer.
Huebner earns $200 per visit, plus an extra $30 for living more than 30 minutes from the testing center. There are supposed to be nine visits over two years. (Each trial site pays slightly differently.) It wasn’t until he arrived that he realized the first visit would last about five hours, but later ones should be shorter.
He was struck, he said, by the fact that he was in this cutting-edge clinical trial, but the paperwork was all, well, on paper. He had to spend hours reviewing documents and initialing, as if he were signing a mortgage.
But the fax machines and photocopies were oddly reassuring, he said.
“I thought it was very amusing how it was very high-tech biology but very low-tech on the forms,” Huebner said. “It kind of gave me a weird sense of: This is something they’ve been doing for so long and it’s such an old-school process.”
The whole trial experience, he said, has felt like an experiment in trying something new.
“It’s a fun adventure,” he said.
Esther Aviles
The experience has been more serious for Esther Aviles. The disease became real when her 14-year-old niece contracted COVID-19 this summer.
The teenager became very sick – and terrified, knowing a number of people in their Seventh Day Adventist church had ended up hospitalized and quite ill. “She realized ‘Wow, that could have been me,” Aviles said. “Thank God it’s not.”
Her niece recovered, and no one else in the family showed signs of the virus, but the experience shook Aviles. A week or two later, when her brother-in-law mentioned the clinical trials, she jumped at the chance to volunteer.
“As a teacher, I feel a responsibility to take care of my students,” she said. “If there’s something I can do to help, I want to do it.”
Aviles, 38, the American-born daughter of Chilean immigrants, was laid off from her teaching job in the Denver area amid the pandemic.
She now lives at her sister’s home in League City, Texas, on the opposite side of Houston from the school where she’s about to start classes. She’ll be teaching music, social studies, English, Spanish and a subject she has never taught before – math – at a school for students with neurological differences. “I think it’s going to be really, really fun.”
Her new classes are small – just four to five students a room – so she’s hopeful in-person classes will work. If not, she’ll send each student home with a ukulele and continue most of their lessons online.
She hopes that she got the active vaccine and that it works, so she can help protect her students. “I’m more them I’m worried about them than myself,” said Aviles, who has no health problems.
Her one hesitation about volunteering for the trial: She hates needles. “The needle part was scary. I won’t lie.” But getting the shot wasn’t as bad as she had expected. Worse was learning how to stick a swab all the way up her nose to collect the samples she’ll need to send in as part of the study. “The blood draw was not a party, either,” she said.
Still, it was worthwhile. “I just felt I needed to do something,” Aviles said. “I’m not a nurse or a doctor. I’m just a teacher doing my thing.”
Raymond Grosswirth
Raymond Grosswirth, 71, is retired, so he has plenty of time to volunteer.
“I felt that there was something I should be doing to help with the situation,” he said.
Grosswirth, who lives in Pittsford, New York, outside Rochester, felt comfortable testing Pfizer’s candidate vaccine, he said, “because of their reputation.”
Two years ago, his wife, Brenda, developed double pneumonia and was on a ventilator for two months. She came out OK, he said, but had nearly died. Now, she’s considered high risk for COVID-19, and “hopefully, by getting the vaccine, it will help to protect her in some way,” said Grosswirth, who was responsible for Rochester’s accounts payable department for 23 years.
The couple haven’t been able to visit their family members in other states, or make their annual trip to Niagara Falls for a theater festival. But they still go to their favorite restaurant once a week, where the tables are appropriately spaced, and they get to talk long walks along the Erie Canal, near their home. Plus he can watch his favorite British movies and TV shows to stave off boredom.
Grosswirth’s health has generally been good. He had prostate cancer 9 years ago, but hasn’t had a recurrence, since.
Getting the first dose of the COVID-19 vaccine wasn’t any different than his annual flu shot, Grosswirth said. His arm was a little sore the first day, but then everything was fine.
He got his second shot recently and had a few more minor side effects – enough to convince him he received the active vaccine. “I’m very happy to be supportive of all the science that’s going into this,” he said.
Kate Estes
Corporate lawyer Kate Estes, of St. Augustine, Florida, said she was drawn in by the science.
Both Pfizer’s and Moderna’s candidate vaccines are based on the same novel technology, called messenger RNA.
Estes said it’s a cool technology and she’d like to be a part of helping this approach reach the general public.
“It’s really neat to think that we may have this revolutionary type of vaccine that could help in all areas of research,” she said, noting the technology may also have potential to treat cancer and other medical conditions.
Estes, 44, said she’s the perfect candidate for the trials, because she has no health conditions and has never had a bad reaction to a vaccine.
Living in Florida, a COVID-19 hot spot back in July, she has known a few friends who caught the virus or had family members who did. One friend’s husband died.
“I just want to do everything I can to further getting a vaccine available so people don’t suffer,” she said.
Estes has been going to work during most of the pandemic, taking lots of precautions. She’s not worried about falling seriously ill herself, but her mother, who has dementia, lives with the family.
That’s why her 16-year-old son started school remotely this week. He misses his friends, of course, but worries about his grandmother more.
Her 21-year-old just headed back to college in Orlando. It’s only two hours away, but it still marks the end of a bonus six months she had with him. “That’s been a gift,” she said.
The things she has yearned for the most over the past six months: dinner parties and concerts. “I really miss being able to get together with groups of people and hear good music. I miss that a lot,” Estes said.
Still, as she and her husband, Thomas, always tell their boys: This won’t last forever.
Estes hopes that her own participation in the trials will help speed things up even a little bit. “I think it would be wonderful if a year from now, most of the population is vaccinated and we’ve put out the pandemic fire,” she said. “That would be amazing.”
Joseph Shilisky
Joseph Shilisky said he wanted to be part of the solution.
“For us to get out of this thing, it’s going to take ordinary people like myself and others,” said Shilisky, 63, who recently took his late mother’s last name after a lifetime as Joseph Smith. “If people don’t step up and volunteer, we’re going to lose more American lives. I’m concerned about America. It’s where I live.”
A lifetime resident of Cleveland Heights, Ohio, Shilisky spent time as a medic in Thailand during the Vietnam War, examining bodies evacuated from the war zone. He spent 15 years as a patrolman on the Cleveland police force, before his post-traumatic stress from the war years got to be too much for him, and he retired.
As a Black man, he said he’s not inclined to put a lot of faith in government. One of his ancestors was part of the famous Tuskegee Study, in which Black men with syphilis were studied for their symptoms but not given treatment or told the true purpose of the research.
But Blacks are being disproportionately hit by COVID-19, just as they have been by hepatitis, HIV and seemingly every other disease, Shilisky said. “It has taken a toll on my community,” he said, adding a sense of humor has always helped him cope. “If you don’t, you’ll be on all kinds of medication.”
He got his first of two vaccine doses recently and had no obvious side effects, which he hopes doesn’t mean he got the placebo.
Shilisky is not particularly afraid of catching COVID-19 himself, because he has never really been sick. The only time he was in a hospital was when he was wounded working security for a bank.
Shilisky still takes walks every day with his huskie-shepherd mix, Sheba. The senior center that was a big part of his life is closed, though. His daughter, a nurse, recently died unexpectedly, so he’s even more concerned than usual about his 14-year-old granddaughter. “I just learned how to FaceTime,” he said, so he can speak to her online.
That’s another reason he volunteered for the trial, he said, for the children. “They’re our future. What a world we’re living in.”
He remembers learning in school about the flu pandemic of 1918, which struck his native Cleveland particularly hard. He has done some research on it recently. “I have nothing else to do. You get tired of watching TV,” he said.
He remembers the 1965 and 1968 riots, so he knows what it’s like to live through historic moments. But it still amazes him that he’s experiencing a pandemic like this himself.
“I just never thought I would live long enough to see this,” he said.
Science, he predicts, will save the day. “American science, that’s where I live at,” he said. “We have the best scientists in the world. They’re going to find a vaccine for this.”
Contact Karen Weintraub at [email protected]
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
This article originally appeared on USA TODAY: COVID vaccine trials need volunteers to sign up for test immunizations
