Einstein Student and Parents Roll Up Their Sleeves for COVID-19 Vaccine Trial

Study’s Unblinding Delivers a Big Surprise

Caroline Boyle figured the odds were in her favor. Two people would receive the real vaccine for each person who got a placebo injection. So the second-year Einstein medical student was happy to enroll last December when the Einstein-Montefiore trial site was seeking volunteers to test the AstraZeneca/Oxford University COVID-19 vaccine.

Barry S. Zingman, M.D.

Barry S. Zingman, M.D.

Coronavirus infections were rising sharply back then, with more than 200,000 cases reported daily in the United States, and an independent analysis had found that the AstraZeneca-Oxford vaccine provoked a powerful immune response against COVID-19.

Ms. Boyle told her 60-something parents, Patrick and Elizabeth, about the trial, and they wanted to sign up too. They’d all be helping science—the real-world effectiveness and side effects were still largely unknown—and each stood a pretty good chance (67%) of receiving the real vaccine.

The Einstein-Montefiore trial site was led by Barry Zingman, M.D., professor of medicine at Einstein and clinical director, infectious diseases at the Moses division of Montefiore Health System. The goal: Enroll 180 people as part of a randomized, placebo-controlled, double-blinded trial of 30,000 Americans to test a vaccine already approved in the United Kingdom. “Dr. Zingman was very helpful,” Mr. Boyle says. “He explained every detail of the trial. He answered any question I had, going step by step.”

Excited and Optimistic

In mid-December, Mr. and Mrs. Boyle traveled two hours from their home in Spring Lake, New Jersey, to the Bronx. “We were very excited to take part,” Mr. Boyle says. “We were also optimistic about helping it get approved here in the United States.”

I first unblinded Mrs. Boyle and then, with trepidation, unblinded Mr. Boyle. I calculated the odds of that happening for all three of them and found that it was just 3.8%.

Barry Zingman, M.D.

Each of them rolled up their sleeve and got the first of two shots. Fortunately, nobody experienced any side effects outside of a sore arm. Their next shot was scheduled for 28 days later.

But then about the first of the year, Ms. Boyle and other medical students were offered the Pfizer shot at Einstein, so she called Dr. Zingman. If given the chance to get a different vaccine, participants in the Astra-Zeneca trial could ask that they be “unblinded” to learn if they’d received the real shot or the placebo. Ms. Boyle was told she had been given the placebo, so she went ahead with the Pfizer vaccine.

A couple of weeks after that, just two days before Mr. and Mrs. Boyle were scheduled to get their second dose of the vaccine at Montefiore, they learned that they could receive the already-approved Moderna vaccine within days. So the couple contacted Dr. Zingman to find out which vaccine they received in the Einstein trial.

“I first unblinded Mrs. Boyle,” Dr. Zingman says, “and then, with trepidation, unblinded Mr. Boyle.” He discovered that both also received the placebo. “I calculated the odds of that happening for all three of them and found that it was just 3.8%. I sent the news to them, apologizing for the dumb luck that all of them randomly got the placebo.”

Ms. Boyle agreed that it seemed unlucky, but took it in stride. “Participating in a clinical trial like this doesn’t mean you necessarily reap the benefits of the vaccine,” she says. “The goal is to help advance science.“

Given the news, Mr. and Mrs. Boyle went ahead with the Moderna vaccine on the same day they were scheduled for their second AstraZeneca shot. “It turned out well,” Mr. Boyle says. “If you do the right thing, good things come to you.”

Dr. Zingman notes the possibility that subjects might get the placebo was factored into the trial. If the AstraZeneca vaccine is found to be safe and effective, it is expected that all of those in the trial who have not been unblinded yet will be told what they received, he explains. Those who got the placebo would then be offered the active vaccine, potentially giving them earlier access than they would have otherwise had.

Analysis of the U.S. portion of the AstraZeneca trial is now in progress, and results are expected very soon. “The study subjects, research teams, and the world anxiously await the results that may lead to availability of another major COVID vaccine,” Dr. Zingman says. “The AstraZeneca vaccine has been approved already in a number of countries—including Canada, most recently—but the results of this very large U.S. study will hopefully validate and further advance results from studies done elsewhere, leading the U.S. and many other countries to approve it. “

Staying in the Trial

Even though all three members of the Boyle family received other COVID-19 vaccines, they were asked to continue with the AstraZeneca/Oxford trial. “We actually went back early last month to have blood drawn again to see how our antibodies were developing,” Mr. Boyle says. They are scheduled to return to Montefiore later this month for more blood work.

“The Johnson & Johnson vaccine was just approved, and I’m hoping the AstraZeneca is right behind it,” Mr. Boyle says. “The sooner we get all these vaccines into people’s arms, the sooner we can get back to normal.”

Mrs. Boyle says she was happy to have been a part of the whole process. “I think vaccinations are a good thing. And it has been horrible living through this pandemic and seeing what it has been doing to people. Anything to end it, honestly,” she says.

Dr. Zingman appreciates the family’s cooperation. “They were so gracious about the whole thing,” he says. “People like the three of them are reasons to be hopeful that we will make it through this pandemic.”