A researcher studies samples of the coronavirus in a state-run laboratory in Pennsylvania. (Photo/Flickr-GovernorTomWolf CC BY 2.0)
A researcher studies samples of the coronavirus in a state-run laboratory in Pennsylvania. (Photo/Flickr-GovernorTomWolf CC BY 2.0)

What happens in a vaccine study? S.F. researcher breaks it down

This is the second part of our four-part Battling Covid series, in which we speak with local Jewish researchers battling the pandemic.

The night before enrollment began for coronavirus vaccine trials at the San Francisco Department of Public Health, Dr. Susan Buchbinder, the site’s principal investigator, was busy. With vaccine maker AstraZeneca finally given the go-ahead on Oct. 29, Buchbinder was ready to marshal a crew of doctors, lab techs and data managers to begin studying one of the most promising vaccines.

But first, she made time to speak with J. — about vaccine research, what “Phase 3” means (testing on humans) and why moving quickly doesn’t mean steps are being skipped.

“What people hear is ‘Operation Warp Speed,’ oh, they must be cutting corners. What’s really important to know is none of the steps are being removed that we usually follow,” she said. “They’re just being compressed in time.”

The trial Buchbinder is supervising is part of a larger study by AstraZeneca. The vaccine, which was developed at the University of Oxford, delivers genetic material from the virus to promote an immune reaction that primes the body to fight the coronavirus if exposed. That’s the aim, anyway. But researchers like Buchbinder need to make sure that’s what is really happening.

Volunteers will get two injections, around a month apart, with one-third receiving a placebo and two-thirds getting the vaccine. The study will look primarily at whether the vaccine can prevent symptomatic Covid, although researchers will also collect data on asymptomatic infections.

The AstraZeneca vaccine was first approved for Phase 3 trials in the U.K. in April and the U.S. in August. But the trials were halted twice after two participants got sick. The U.S. only gave the OK for the study to start up again on Oct. 23 after the data was reviewed by the Food and Drug Administration.

Buchbinder’s vaccine testing is being done at Bridge HIV, part of the S.F. health department. She is the director of the city’s HIV-prevention research, as well as a professor of medicine and epidemiology at UCSF. She said that working on a Covid vaccine is not all that different from working on an HIV vaccine, in terms of infrastructure and staff.

“So many different groups of people, with different kinds of expertise, are all required to do any kind of vaccine study,” Buchbinder said. “The type of vaccine isn’t as important as the fact that we’re doing a vaccine trial, because many of the components of what we actually do in a vaccine trial are very similar.”

Dr. Susan Buchbinder
Dr. Susan Buchbinder

That includes managing a tremendous amount of data on the health histories of volunteers, tracking their responses to any exposure, and making sure they have mental health and medical services available. There are staff members who do the swabbing and jabbing, and others who coordinate the lab work.

“You can see that it takes a small village just to run this particular trial,” Buchbinder said.

Only 250 volunteers will be enrolled through the Bridge site, but it’s just one piece of the larger AstraZeneca Phase 3 trial. In the Bay Area, there are also sites at Zuckerberg San Francisco General Hospital and in Oakland at Sutter Health’s East Bay AIDS Center, and there are test sites across the country.

“I think that they’re planning an overall six- to eight-week enrollment period for the entire 30,000-person trial” across the U.S., Buchbinder said, which makes it “about average” in size.

Studies in the U.K., Brazil and South Africa, plus planned trials in Russia and Japan, will bring the total enrollment to “up to 50,000” people, according to AstraZeneca.

“There will be data coming in from multiple sources that we’ll be able to piece together as we look at this,” Buchbinder said.

It’s a double-blind study, so even the researchers don’t know who is in the control group and who is getting the vaccine. Neither group is deliberately exposed to the coronavirus; rather, participants are encouraged to live their lives taking normal precautions. If they are exposed, they’ll be monitored to see if they contract Covid and track any symptoms.

“Phase 3 is the stage where we’ll find out whether or not the vaccine provides protection,” she said. “But that’s just the beginning of things, that’s not the end of things.”

Once the trial is over — hopefully showing that the vaccine works — then other questions come. Buchbinder said the FDA is requiring researchers to follow study participants for about two months after their final dose because issues with vaccines tend to emerge in the first four to six weeks.

“Then the FDA needs to review all of the data to be sure that it’s both safe and effective,” Buchbinder said. “They need to make a determination that they have enough data to authorize [the vaccine’s] use. And then there are myriad questions on how you actually distribute the vaccine in a safe and equitable way to the highest priority populations.”

As to when a vaccine will become widely available, Buchbinder can’t say. But she’s encouraged by all of the research on different methods to protect people from Covid.

“There’s six different vaccine products that are each being tested to see whether or not they protect against disease,” she explained. “We’re doing the AstraZeneca vaccine, but there’s the Moderna vaccine, the Pfizer vaccine, there’s a Johnson & Johnson vaccine, Novavax and Sanofi. All of these different companies have completely different vaccine products.”

They may not all make it past Phase 3 trials to emergency-use authorization, she said, but the more that do the better, as that will provide multiple ways to push back against the virus.

Buchbinder said she’s happy to be contributing to such essential work. “There’s a lot of work to be done, and it’s also tremendously exciting to be able to try to be part of the solution,” she said. “Because I think we’re all clear that we desperately need a vaccine.”

The “true heroes,” she said, are the volunteers who have been signing up to enroll in her study — and all the studies that are happening in the U.S.

“I ask them, ‘So tell me why you’re interested in participating in this study?’ And overwhelmingly the reason … is they want to help, they want to try to find a solution.”

Maya Mirsky
Maya Mirsky

Maya Mirsky is a J. Staff Writer based in Oakland.