Henrico firm conducting clinical trial for AstraZeneca's COVID-19 vaccine

Henrico’s Clinical Research Partners is in the process of conducting a two-year clinical trial for biopharmaceutical company AstraZeneca’s COVID-19 vaccine, during which participants will take two injections of the vaccine.

The trial opened up Oct. 28 with about 12 participants, according to Clinical Research Partners President and Medical Director Robert Call. Since then, about 1,455 people have signed up and received injections.

“We’re looking for people who have increased risk of exposure, in addition to those who are at risk of having worse problems from COVID,” Call said. “We’re also looking at diversity, which we have a lot of in our clinical trials to begin with and was one reason why we got chosen by AstraZeneca.”

In addition to diversity, Clinical Research Partners also was most likely chosen because of its research experience with a variety of vaccines and its location, since Metro Richmond was a COVID-19 hot spot for a time, Call said.

For participants, day one of the trial consists of going through a questionnaire, getting a physical, having blood drawn, getting a nose swab to ensure they don’t already have COVID-19 and then getting the vaccine. On day 29, they receive the second injection. There are weekly phone calls to track symptoms and participants will have their blood drawn every several months.

In the trial, two out of three participants receive the vaccine and the rest get a placebo.

“When the AstraZeneca vaccine comes out, they’re going to unblind it and give the placebo people the vaccine, that’s the latest I’ve read recently,” Call said. “The most important thing in any trial is volunteer safety. There’s a lot of COVID out there, so no one’s going to stay in a study for two years on placebo. It would be unethical.”

There are limitations for participants on taking other vaccines during the trial, with the exception of the flu vaccine.

“There’s a 30-day moratorium around any other vaccine, 30 days before the first and 30 days after the second,” Call said. “AstraZeneca doesn’t want anything clouding the results where it’s hard to know what the impact would be of two different vaccines.”

About four participants have contracted the virus during the trial so far, Call said.

“If people do get COVID, we bring them in and assess them, draw blood, and look for antibodies and also viral shedding in the saliva,” Call said. “They stay in the study and that’s just another data point. But, if they get COVID in between the two injections, they will not get the second injection, because presumably they wouldn’t need it.”

Clinical Research Partners had an influx of willing participants after the Richmond Times-Dispatch and Channel 6 News put out information about the clinical trial, Call said.

One participant, Dave, decided to participate in the trial after reading about it online. His daughter also is a participant.

“Selfishly, I wanted to get vaccinated,” he said. “Knowing enough about vaccines, I’m not worried, especially by Phase 3. We’ve been doing vaccines long enough.”

There were a couple of delays in the study, so Dave was originally supposed to get the first round of vaccine in September, but didn’t end up getting it until Dec. 17, he said.

“I had minimal symptoms,” Dave said. “My daughter had a little more than I did. She had a headache and a bit of nausea for maybe 12-15 hours, but it was taken care of by Ibuprofen. I had a headache and, while running, I had a little nausea, but it was gone after I stopped.”