The Atlanta Journal-Constitution
3 women on front lines of Zika vaccine tests
Atlanta resident among volunteers being monitored.
They are three women who have spent months getting an experimental vaccine in the name of science. On each date of a strict timetable, they’ve headed to windowless exam rooms in Bethesda, Md., Baltimore and Atlanta and stuck out their arms to get an injection or to have blood drawn. Or both.
How their bodies react will determine whether this clinical trial — one of the first — proceeds to the next stage in a long and complicated process. Its target is Zika, a virus that since 2015 has spread with a vengeance to 58 countries, infecting hundreds of thousands of pregnant women and putting their babies at risk of birth defects.
In Bethesda, volunteer Andrea Vaught is a researcher who is earning a master’s degree in public health. Being part of a clinical trial appeals to her inner geek.
In Baltimore, volunteer Crystal Woodley is grateful for the $1,100 compensation, given her recent layoff from a night-shift warehouse job.
And in Atlanta, volunteer Virginia Bliss is motivated by love and gratitude for her 10-year-old daughter.
“My daughter is perfect in almost every way, and I’m very blessed,” said Bliss, who works at a primate research center. “I wouldn’t want something to happen to someone during pregnancy that’s so far beyond their control. I can only imagine how heartbreaking that would be.”
The trio is at the heart of an effort by scientists worldwide. At least six vaccine candidates are in the development pipeline in the United States, with drug companies and government institutions collaborating to accelerate the process.
There is special urgency with all this work. Zika has confounded the medical community with its unpredictability, and virtually every week, research provides disturbing new data about its damaging potential in the unborn, infants and even adults. The World Health Organization now considers Zika “a significant and enduring public health challenge.”
Yet vaccines usually take at least a decade to develop because so much of the effort is trial-and-error.
“When you are dealing with something that is going to require a response in a human body, which has so many variables ... person to person,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, “the chances for lack of precision and for something to go wrong is much greater.”
Vaught, Woodley and Bliss are part of a trial led by NIAID. It may be the furthest along — having had no trouble attracting participants, particularly among women — and about 80 people have received multiple injections since August of the clear, colorless test preparation. By design, no participants are pregnant.
If things keep going smoothly with this safety testing, researchers hope to move to Phase 2 in February. That would involve trying the experimental vaccine in 2,400 to 5,000 volunteers in places where the virus is spreading to see whether it prevents infection.
One way to speed up the overall development of a Zika vaccine would be to conduct a separate trial with a vaccine that contains live virus, something the current formulation does not contain. A decision could come later this month, and scientists know that recruiting for such a controversial trial would be much more difficult.
Any such volunteers would be on the front lines of the Zika fight, just as Vaught, Woodley and Bliss are.
‘Because it matters’
On a cold, blustery morning, Vaught arrived at Building 10 — the Clinical Center — on the National Institutes of Health campus in Bethesda, for her second vaccine injection. From there, the 25-year-old would head to work at Georgetown University’s Center for Global Health Science and Security, where she helps countries develop surveillance systems to prevent outbreaks.
“With everything going on in the world, I know I can sometimes feel powerless to do something,” she said. “This is a small way to contribute to the development of a vaccine. I’m a young, healthy person, and that’s a privilege that I can contribute in this way.”
She hasn’t had much of a reaction to the shots. After her first in September, she felt a little tired. But she wasn’t sure whether to blame the vaccine or her schedule as a full-time research assistant and part-time student at George Washington University.
Before every injection, she provides a urine sample to make sure she’s not pregnant, has her vital signs checked and then gets her blood taken so her body’s immune response can be assessed. All participants receive the same dose — four milligrams of a small, circular piece of DNA, called a plasmid, in one milliliter of saline. It must be individually prepared each time.
Phlebotomist Catina Boyd jokingly calls Vaught her “problem child” because her veins are so tiny that drawing blood takes finesse. Boyd makes the tourniquet extra tight and hands Vaught a plush toy — in the shape of an NIH bus — that she’ll squeeze to make her veins pop and keep the blood flowing.
“Squeeze and hold the bus,” Boyd tells her.
New technology allowed NIAID researchers to engineer the plasmid so it contains genes coded for proteins of the Zika virus. When injected, a person’s cells read the genes and make those Zika proteins, which in turn trick the body into mounting a defense with antibodies and T cells.
Such DNA vaccines don’t have infectious material, so researchers say they can’t cause a person to become infected with Zika; previous trials for other diseases have established their safety, but DNA vaccines haven’t yet made it to market for human use. When people call to ask about volunteering, “that’s one of the first conversations we have when they inquire,” said Julie Ledgerwood, the trial’s primary investigator. Everyone is reassured: “There’s no Zika virus. You can’t get Zika from the vaccine.”
All participants, who must be between 18 and 35 years old and “pristinely healthy,” in Ledgerwood’s words, receive two to three injections and commit to as many as 18 follow-up visits over two years. After each shot, they record their temperature and any fever, arm pain, redness or tenderness, nausea or headache. They return on a specific schedule to have more blood taken so researchers can monitor their health and immune response.
Zika’s high profile has attracted a far greater response than usual from potential volunteers — with so many inquiries that Ledgerwood ended up with names to tap for future Zika studies. Many of the people selected are women, perhaps because of Zika’s far greater consequences for pregnant women and their babies.
“People want to do this because it matters,” she said.
Being a first-time participant has given Vaught a different perspective on her graduate classes’ textbook discussions about designing clinical trials and effective sample sizes.
“It is actual people you are testing something on, and sometimes we can forget that,” she said.
‘It’s to help people’
Woodley was running late for her second shot in downtown Baltimore. Her ride didn’t show. She didn’t have time to wait for a bus. She took a taxi, arriving at the vaccine clinic at the University of Maryland School of Medicine at 10:50 a.m., almost an hour past her appointment time.
As soon as she walked in, Ginny Cummings, the no-nonsense study coordinator, picked up the telephone to notify the pharmacists to start preparing her dose.
“Let the mixing begin,” she said.
Woodley took part several years ago in a malaria trial at the medical school, a study that required her to be in the hospital for nearly two weeks. Volunteers had their vitals recorded every three hours.
“We had to drink something that had malaria in it, and they would collect our stool every day,” she said.
Some people became ill, but not Woodley.
“I think I had the placebo,” she said.
The experience piqued her interest, and she agreed to be contacted about future trials. The timing on this one worked well because she’d been laid off in April. She also welcomed the compensation, which depends on a volunteer’s number of visits and the time needed to reach a facility.
A doctor went over a checklist to make sure Woodley, 33, could still receive her shot. Still in good health? No recent vaccinations? No blood products? Check, check, check.
By then, another clinic staffer had returned with her dose. Minutes later, in a spot right above the “RIP Daddy” tattoo on her left arm, Woodley received her injection. Like every participant, she had to stay put for 30 minutes and be monitored for any adverse reactions. There were none.
Just before noon, she walked outside, waited in a light drizzle for her bus and rode the No. 23 home to Catonsville.
“I really like what they’re doing,” Woodley said of the researchers, some of whom she knows from her previous trial. “It’s to help people and prevent them from getting this disease.”
Investigators say volunteers haven’t reported any significant pain or unusual side effects. But interim data suggest their immune response “is lower than we would have expected,” Fauci said. He described it as “adequate, but not great.”