Phase 3 COVID-19 vaccine trials start at Emory, giving Atlantans a potential shot at immunity

In early August at least 1,000 Atlantans will join a historic vaccine trial. Should you be one of them?

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COVID-19 phase 3 vaccine trials Atlanta

Photograph by Davizro / iStock / Getty Images Plus

News about the pandemic has been relentlessly bad, but there’s reason for hope. Last week, scientists reported that the first COVID-19 vaccine trial in humans showed an immune response similar to the one found in people who recovered from COVID-19 infection—an important first hurdle in the race for a vaccine. Now, a new phase begins, and Atlantans can volunteer for the study that will ultimately show whether or not this vaccine will help combat the pandemic.

Forty-five healthy adults took that first shot (and a second one a month later), helping researchers figure out which of three dosing levels triggers neutralizing antibodies (proteins produced by the immune system that help fight off infection) with the least side effects. The vaccine was developed by Massachusetts-based biotech company Moderna Therapeutics and the National Institute of Allergy and Infectious Diseases.

Creating a vaccine usually takes years—or even a decade or longer—but this timeline is historically fast. In the spring, the first trial, known as Phase 1, expanded to include older adults, and Phase 2 enrolled 600 people, split between those 18 to 55 years old and older adults. Results of those studies haven’t yet been reported.

Emory University, one of only two sites for early tests of the Moderna vaccine, is now looking for adults of all ages to enroll in Phase 3—the last stage required before a vaccine can receive approval from the U.S. Food and Drug Administration. Some 30,000 people around the country will join the study, which can be accessed through the COVID-19 Prevention Network. Think you want to be one of them? Here is some information that may help you decide. 

Can I get COVID-19 from the vaccine?
No. It doesn’t contain the virus—not even an inactivated form of it. This is a new type of vaccine that uses synthetic genetic material (called messenger RNA) that encodes for the protein in the outer spikes of the coronavirus. The body’s cells make copies of the coronavirus protein, triggering the immune system to mobilize to fight off the intruder. The Phase 1 study showed that everyone who received two doses of the vaccine developed neutralizing antibodies, or antibodies that block infection. The vaccine also produced a T-cell response, immune cells that help coordinate the attack on a pathogen and that hunt and destroy cells infected with the virus.

So, if I join the vaccine trial, will I be protected against COVID-19 infection?
Not necessarily. Half of the people in the trial will receive a placebo (a saline injection)—and when you get the shots, you won’t know whether they are the real thing. “There is a very high likelihood that participants will learn if they have received placebo, but this could be after the study is completed,” Evan Anderson, an infectious disease doctor and principal investigator of the Moderna trial at Emory, told Atlanta via email. “If this vaccine or another vaccine is licensed because it is safe and effective before this study finishes, placebo recipients may be able to receive actual vaccine, but we have not been given a guarantee of this yet from the sponsor [Moderna].”

Even if you get the vaccine—and produce an immune response—it’s not yet clear how protective that will be against SARS-CoV-2 infection (the virus that causes COVID-19) or how long any protection will last. That’s what researchers hope to learn from the Phase 3 trial.

What if I get COVID-19 despite getting the vaccine?
A vaccine that provides even limited protection would be a win—if not for you, for the country and the world. The FDA has said it would consider a vaccine for approval if it reduces infection or severe disease by at least 50 percent. Vaccine expert Paul Offit says a “reasonable goal” would be to create a vaccine that is 70 percent effective in preventing moderate or severe disease. “If we can do that, it’ll keep people out of the hospital and it’ll keep people from dying,” says Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, who is not involved in the trial.

What side effects does the vaccine cause?
Not surprisingly, almost everyone reported pain at the injection site. Most of the 600 participants had flu-like symptoms (headache, chills, fatigue, achiness) after the second dose—mild for most people who got the lowest dose of 50 micrograms and more often moderate in those with the highest dose of 250 micrograms. (Phase 3 contains the middle dose, 100 micrograms, which had more mild reactions than with the highest dose.)

One participant developed hives after receiving a low dose and dropped out of the study, since that could be a sign of an allergic reaction. One person developed a 103-degree fever the day after getting a second high-dose vaccination, along with fatigue, achiness, severe chills, and headache, and later vomited and fainted after becoming lightheaded. The 29-year-old man from Seattle, who told his story to the medical news site STAT, said he felt better within a day and had no more ill effects. Two other people had effects that were considered severe, such as chills, fatigue, or redness at the injection site, but they resolved without any safety concerns, according to the report in the New England Journal of Medicine.

All in all, Phase 1 didn’t reveal any red flags. The large Phase 3 study would be more likely to unearth any rare serious side effects. Offit notes that a safety monitoring board will continuously review data and has the power the pause or stop a study, if necessary.

Can anyone sign up for the vaccine trial?
The trial is open to adults 18 and older, but there are a few exclusions. You can’t participate if you have an immune deficiency, if you’ve ever had SARS-CoV-2 infection (even if you never had symptoms of COVID-19), if you’ve ever had an allergic reaction to a vaccine, or if you are pregnant or breastfeeding.

Researchers are interested in how well the vaccine protects people who are vulnerable to COVID-19, so you can enroll if you have a medical condition (such as diabetes or hypertension) as long as it has been stable for at least three months. You can complete a registration form with the COVID-19 Prevention Network or you can contact one of the three Emory-related sites: Emory Children’s Center at Emory University; Hope Clinic in Decatur; or the Infectious Disease Program at the Ponce de Leon Center.

“There will also be hundreds of sites across the U.S.,” says Nadine Rouphael, interim director of the Hope Clinic and principal investigator for Emory’s Vaccine Treatment Evaluation Unit. “There will be opportunities for participants here within Atlanta, but we’re also trying to engage the community at large within the state, particularly communities that have been hit the hardest with COVID [such as] the African American community and Latinx community.”

What should I expect if I join the study?
You will receive a lengthy document explaining the potential risks of the vaccine trial, and you’ll have a chance to ask questions before you sign the informed consent. You need to agree that, in addition to getting the two shots, you will come for scheduled appointments to check for symptoms and have your blood drawn for testing. The study period may last up to two years.

Sean Doyle, an MD/PhD student at Emory, was one of the first to get a COVID-19 vaccine in the Moderna trial. It happened to be the same dose chosen for the Phase 3 vaccine. The experience was “uneventful,” he says. His arm was a little tender around the injection site, and he felt a little more tired than usual a few hours after getting the vaccine. That’s it. His advice? “I would encourage folks to participate in this trial knowing it would contribute to the development of COVID-19 vaccines in general, but it doesn’t necessarily mean they will be immune after getting the vaccine,” he says. You will still need to wear a mask, stay six feet from other people, and wash your hands frequently, he says.

When news about Phase 1 emerged, thousands of people called Emory asking if they could be among the first to get an experimental COVID-19 vaccine. Phase 3 is likely to be similarly popular. But if you don’t make it into the Moderna trial, you may get another chance. According to the World Health Organization, 24 COVID-19 vaccines are currently in human trials and 142 are in development.

Correction: A previous version of this story said that the Phase 3 trials would begin at Emory on July 27. They will begin in early August.

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