UCSD to enroll area residents in nationwide COVID-19 vaccine trial set to begin next week

UC San Diego will enroll a large, diverse group of area residents in a trial of a COVID-19 vaccine developed by researchers at Oxford University and British pharma giant AstraZeneca set to begin Tuesday, Sept. 8.

A nationwide trial of the Oxford-AstraZeneca vaccine will include 30,000 people in 36 states. UCSD hopes to enroll 1,600 in San Diego County and an additional 1,200 in Imperial County through a partnership with El Centro Regional Medical Center.

It’s the second massive COVID-19 vaccine trial to come to San Diego. The first, which tests a vaccine developed by Massachusetts biotech Moderna, is still underway after launching in late July.

“We’re really hoping to invite members of the community who are ready to be part of the solution and participate in these local-backed vaccine clinical trials,” said Dr. Susan Little, director of the UCSD trial site.

“We’re in this together. We want to get out of this together.”

What do we know about the Oxford-AstraZeneca vaccine?

The vaccine uses a common cold virus that infects chimps but has been modified to be safe in people and carry instructions that teach the human body to target the surface of the coronavirus that causes COVID-19.

Results from an initial trial of about 1,000 participants showed that those who got the vaccine made antibodies, Y-shaped immune proteins that can latch onto the surface of a virus and prevent infection.

The study also showed that the vaccine was safe overall. The most common side effects were short-term fatigue, headache and soreness around the injection site.

Using a chimp virus may seem like an odd way to design a vaccine, but Oxford researchers have safely used this particular virus before to test an experimental vaccine for Middle East respiratory symptom (MERS). Like COVID-19, MERS is caused by a member of the coronavirus family.

Oxford researchers designed the vaccine, and AstraZeneca is spearheading its development, manufacturing and distribution.

The company is one of a select few that are part of Operation Warp Speed, the U.S. government’s bid to deliver 300 million doses of a COVID-19 vaccine by January. The government has offered AstraZeneca up to $1.2 billion to fund the company’s trials and to secure at least 300 million doses of its vaccine.

But no doses will be doled out until researchers are certain the vaccine works. That’s what the upcoming trial will test.

Who is eligible, and how will the trial work?

Trial organizers are looking for people with an above-average chance of being exposed to the coronavirus based on where they live and work but who haven’t been infected yet.

If you were to vaccinate those who already had the disease, you would never know whether they were protected by their previous immune response or by the vaccine.

But if you vaccinate people who likely will never be exposed to the virus, you also won’t know whether the vaccine worked. That’s why these trials are so large — so that enough participants get exposed to the coronavirus for researchers to know whether a vaccine works.

Researchers are looking for healthy adults 18 and older, including those who are in stable condition and have pre-existing conditions such as high blood pressure, diabetes or heart disease.

UCSD will prioritize enrolling minority communities and essential workers, groups that have been hardest hit by COVID-19. Little said her goal is for at least 30 percent of participants to be people of color.

That focus has shaped the trial’s design in two ways. For one thing, participants won’t need to go to UCSD in La Jolla. Instead, the vaccine will be coming to a parking lot near you.

Trial staff will administer the vaccine from a specially equipped bus set up in parking lots across San Diego, El Cajon, Imperial Beach, Chula Vista and National City. Those who enroll in the trial will be invited to the site nearest them.

“If we’re going to prioritize these communities, we should go to them,” Little said.

The second notable adjustment is that UCSD will run a satellite trial at El Centro Regional Medical Center. Imperial County has been hit hard by COVID-19, with 15.3 percent of coronavirus tests there coming back positive, compared with 3.7 percent in San Diego County.

Regardless of location, two of every three trial participants will get two injections of the Oxford-AstraZeneca vaccine, four weeks apart. Everyone else will get two placebo injections of salt water. Who gets which injection will be assigned at random.

The hope is that people who receive the vaccine will be less likely to develop COVID-19 than those who get the placebo — and that the vaccine helps those who do get sick recover quickly. Researchers and regulators will look for early, clear signs that the vaccine is working in coming months, though study participants will continue to be monitored for the next two years.

Anyone who experiences COVID-19 symptoms — such as fever, headache or loss of smell — for more than one day will be tested for the coronavirus.

UCSD will deploy vans that will zip around San Diego County to administer tests to participants. If need be, they’ll go to the home of anyone who is sick.

Anyone who tests positive for the coronavirus will be asked to wear an arm band that will track temperature, heart rate and other health measures. If any of those measurements veer into concerning territory, study monitors will call participants to see if they need medical attention.

“Participant safety is paramount in all of these studies,” Little said.

How do I sign up or learn more?

Visit covidvaccinesd.com or call (619) 742-0433. ◆