Emory University in phase 1 of human clinical trials for SARS-CoV-2 vaccine

Posted at 4:13 PM, May 04, 2020

ATLANTA, Ga. – Several weeks ago, Carol Kelly volunteered to participate in a vaccine trial because she had some extra time on her hands. When the clinic at Emory University in Georgia reached out to her, she found out it was a clinical trial involving COVID-19.

“I thought wouldn’t that be neat if it was one of the COVID trials, and sure enough it was,” Kelly said. “A part of me was excited because I thought well ‘who doesn’t know about COVID-19’, and then when she sent me the packet of information I kind of took a little bit of a pause because this vaccine has never been used in humans before”

Trusting the caliber and ethics at Emory University, she got her first dose of the vaccine on April 21. Dr. Evan Anderson, an Associate Professor of Medicine and Pediatrics at Emory School of Medicine, is part of the research team developing the vaccine.

“This vaccine trial is a little unusual in that it’s testing a new method of vaccine production. It’s called an MRNA vaccine or Messenger RNA vaccine,” Dr. Anderson said.

In this case, researchers are using a section of genetic code for the spike proteins of the virus – they’re the spikes that stick off the round ball of coronavirus. The vaccine is being injected into individuals with the hope that the MRNA will be taken up by the person’s own cells.

“And hopefully the immune system will then recognize that spike protein as being foreign and develop an immune response against it,” Dr. Anderson said.

Right now, Emory is in phase one of its human clinical trials. They’ve only injected the vaccine into a few individuals starting with healthy 18-to-55-year-olds, but since the virus is greatly impacting the elderly, they’re now relying on older volunteers.

“A decision was made to expand the enrollment of 56-to-70-year-olds in several cohorts of low, medium and high dose, and ultimately those 71 and above, once again with either a low dose, intermediate dose or high dose.”

Different doses need to be tested in order to discover how much of a dose someone may need for the vaccine to be effective. There are a few risks involved. That’s why volunteers like Kelly had to pass all questioning and bloodwork before officially being a part of the trial.

“Those include local symptoms meaning pain, redness, swelling, tenderness, soreness at the site of injection,” Dr. Anderson said.

That reaction is likely to be experienced by many individuals who receive any vaccine. A select few could experience flu-like symptoms.

“The day or couple days after they receive the vaccine, they have symptoms of fevers or chills or achiness, kind of not feeling your usual self in the days after you receive the vaccine.”

An allergic reaction is also possible, but none of that has been the case for Kelly. She hasn't experienced any side effects. So far, Dr. Anderson says there haven’t been any red flags associated with the study, but that could quickly change.

“There are a number of reasons why the vaccine might not work," Dr. Anderson said. "Either the body doesn’t respond to the vaccine because the immune system doesn’t recognize the vaccine, or the dose is not high enough in order to generate an immune response – that’s a real possibility so we may not see any response to the vaccine. Another possibility – and this is something that we worry about and think about a little bit – is the possibility of the vaccine actually increasing the risk of COVID-19 disease.”

These possibilities are why Dr. Anderson says it’s important to invest in many different types of vaccines. He’s aware of more than 100 early-phase vaccine candidates being initially trialed in animals.

Once a vaccine is proven successful, the next challenge is getting it distributed to the public.

“The company that’s successful in terms of moving a vaccine through to FDA licensure will then have to look at being able to roll out hundreds of millions of doses just to meet the U.S. need, not to mention additional need worldwide which could be in the billions of doses of vaccine.”

There are so many potential issues that can arise when creating and manufacturing a vaccine which is why it takes so long to get it out for everyone. The million-dollar question: when will a vaccine finally be on the market?

“The answer is not as soon as everyone would like. We’d all like to get back to quote unquote normal.”

Dr. Anderson says current predictions show a vaccine could be ready by 2021.

“If it works, this may be one of the hopefully solutions for all of us and we would be vaccinated against it. Just like we would be vaccinated against Polio or one of those other diseases that ravaged humans,” Kelly said.

Kelly says the main reason she decided to be a part of the study is because she knew it was one way she could help others.

“A lot of people are really suffering. Whether it’s through the illness itself, or because of jobless and financial hardship and so on, that if I could be a little itty-bitty link, I will have so much gratitude for that,” Kelly said.