Trial participants help researchers test new COVID-19 vaccines



“I’m not sure that vein is as good on the left,” said Charles Jones, 21, of Poulsbo, looking at his right arm.

Jones, an undergraduate student at the University of Washington, really got to know his veins. He is lying on an examination table at Harborview Medical Center at the University of Washington in Seattle on June 10, preparing for another blood test as a participant in a COVID vaccine clinical trial.

Some might wonder why he would want to do something experimental when there is an abundance of vaccines approved by the Food and Drug Administration. Jones says contributing to the science and possibly improving his immune system beyond what previously licensed vaccines can accomplish is worth it. He may have a bit of buyer’s remorse, but not in the long run.

“It might be more convenient to get the shot, but I think the pros outweigh the cons,” says Jones, who studies psychology and business while working part-time and as a teaching assistant. .

Luckily Jones has good veins, Dr Tia Babu tells him. She does the blood test after taking Jones’ vital signs on his first visit to the clinic since he received his first dose of a second-generation coronavirus vaccine, a vaccine the researchers hope to provide long-lasting

immunity to the virus and its variants.

Over the past few months, Babu and Dr Anna Wald, the study’s lead investigator at UW, have planned and conducted preliminary clinical trials of the CORAL vaccine from biotech company Gritstone. Gritstone’s “second generation” vaccine adds more defenses to the mix. It will – the manufacturer hopes – engage parts of the immune system that some existing vaccines do not reach.

Researchers suspect that the new vaccine will offer even broader immunity than those that have already received FDA approval and entered the market.

Although they missed out on some summer social activities and have no guaranteed immunity levels, trial participants believe more time under lockdown is worth it to advance science. Doctors, both infectious disease specialists and professors of the University of

Washington School of Medicine, aims to enroll 40 unvaccinated people in the study. After only a few weeks of active registration of people, five participants are already vaccinated; many more reached out to register.

“It turns out there are a lot of selfless people in Seattle and Washington state who want to make a contribution,” says Wald.

Subjects from other CORAL trial sites received doses as early as March 30, but Seattle-based participants did not receive their vaccines until May at the earliest, when other COVID vaccines cleared for experimental use. emergency services were already available. With FDA-approved vaccines already available and a host of other vaccines

Long-running trials, those involved in the Seattle CORAL study wondered if they would find enough unvaccinated volunteers.

“I was just like, ‘Who’s going to do this when you can just go get the shot? ”Says Kirsten Hauge, clinic director responsible for program operations at the UW Virology Research Clinic. “And I was surprised by the number of people we had.”

Decide to participate in the trial

Having moved to Seattle with his wife just before the start of the pandemic, Nicole Rundlett was looking for a way to give back in a meaningful way when she heard about the vaccine trial.

A traveling sales manager, Rundlett is not used to spending so much time around and at home. She kept busy exercising, brewing beer, and filling a quarter of her 800 square foot porch with potted plants, but needed a community-driven outlet.

Having heard various vaccine conspiracy theories, Rundlett – who comes from a family of medical workers, but had never been in a research study – believed she could lead by example. “I felt I had to do something to help,” she says.

Some trial members go to great lengths to test the vaccine. Jones lives in Poulsbo, and it takes her an hour or two by ferry to reach the First Hill clinic in Seattle. He has visited at least five times, starting April 20.

Jones worried about whether he would need an approved vaccine to attend class when UW reopens in the fall, but liked the idea of ​​having the stronger immunity CORAL could offer. . He was also encouraged by his mother, who suffers from cystic fibrosis, a disease that makes people more vulnerable to COVID. “She was so excited that I could get involved in something that would help people with cystic fibrosis,” he says.

As other people began to receive proven vaccines, Rundlett and Jones agreed to bide their time.

How the vaccine works

Where the first generation of COVID vaccines have been shown to induce antibodies using the virus spike protein, Gritstone’s second generation CORAL vaccine adds more defenses to the mix.

They are experimenting not only by targeting different parts of the immune system, but using different types of vaccine delivery systems – adenovirus and mRNA – in the same patient.

Gritstone Scientific Director Dr. Karin Jooss says the CORAL vaccine is designed to fight the virus if it manages to infect cells. The antibodies may not catch all of the virus you are exposed to when it enters your body. This vaccine could stimulate T cells – killer white blood cells – which can kill infected cells. Gritstone’s goal is to get the immune systems to respond quickly, even a year or two after inoculation.

“We felt that we needed to induce both arms of the immune system for better protection against the virus,” explains Jooss. This cellular-level immunity can also protect a vaccine recipient against new variants, says Wald, a UW Medicine researcher leading the Seattle study.

Gritstone has been developing cancer vaccines for years. Since the start of the pandemic, he has tried to apply this expertise to a vaccine against the coronavirus. Investigators from the four test sites – UW, as well as Baylor, Emory and St. Louis universities – are working with

Gritstone and the National Institute of Allergy and Infectious Diseases to test CORAL in the Phase 1 study.

Regardless of the effectiveness of existing vaccines, those already on the market are difficult to store and probably don’t exist in sufficient quantities to help the whole world bring the virus under control.

“There are over 7 billion people in the world, so we need more vaccines and different types of vaccines to get everyone vaccinated,” Wald said.

The trial

Getting into the trial is difficult. Participants should be in very good health, with a low likelihood of exposure to the coronavirus. Unvaccinated subjects are technically referred to as “naive” subjects – ironic, as Babu and his colleagues make sure they are fully informed.

“I am first and foremost a doctor,” says Babu. “I want them to understand everything before they decide,” she says.

Participants in the trial are given either two of the same types of vaccines or an mRNA and an adenovirus. They also receive versions of the vaccine with either just a spike protein or a spike protein with additional proteins targeting the T cell arm of the immune system.

While a few participants were enrolled in early May, the researchers voluntarily suspended the trial for a few weeks while awaiting recommendations from the Centers for Disease Control and Prevention on the Johnson & Johnson vaccine, which also uses an adenovirus platform.

When the trial restarted, researchers allowed participants to choose not to receive the adenovirus vaccine, but no one in the Seattle trial had chosen that option in early June.

Rundlett says the lawsuit gave him reassurance that, “yes, the medical community is doing this absolutely for the good of mankind and not for some nefarious type of reason.”

She has had to give up some tempting social opportunities as part of the trial, as she cannot yet assume that she is immune. She had planned to visit friends recently, but withdrew because they wanted to go to breweries. “I just decided: ‘let’s wait a month or so.’ “

Lack of unvaccinated subjects

It will be months before Rundlett or Jones will know if they are protected against the coronavirus. Investigators plan to tell participants if they developed any antibodies about three months after the last enrolled received a second dose. Waiting isn’t easy, says Rundlett.

“I guess there’s that unknown still… so I’m thrilled to see these results,” says Rundlett. “There are so many things that I look forward to. And I think my patience is running out a bit.

The supply of unvaccinated volunteers – at least in the United States – is small, however, and clinicians like Wald and Babu will soon have to take this into account when testing new vaccines.

Gritstone had originally planned to start a second study later this year, a study that uses its vaccine as a booster dose in people who have received first-generation vaccines, such as those produced by Pfizer and Moderna. But this week, researchers were given the green light to incorporate this booster trial into this existing trial, giving some people a dose of the CORAL vaccine. They hope to start screening people for the booster trial soon, and expect the core of their study to focus on booster shots.

The contributions made by people like Rundlett and Jones, however, are vital to ongoing research, Babu pointed out.

“I think we need to continue to have volunteers like us ready to do it,” says Rundlett. “And I guess for myself, I definitely think I would participate in other trials based on that experience.”

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