The first phase 3 trial of a coronavirus vaccine began this week, with plans to enroll 30,000 volunteers by the time it’s over—and more phase 3 trials are likely to begin soon. While we’re all hoping for a safe, effective vaccine as soon as possible, the only way to find out whether it’s safe and effective is for volunteers to give it a try.
Human vaccine trials, like drug trials, come in three phases. In the first two, researchers figure out the appropriate dose, make sure that any side effects aren’t too severe and, of course, that the vaccine elicits an immune response. The third phase is “the definitive trial,” physician scientist John Cooke told us. It involves large numbers of volunteers who get either the experimental vaccine or a placebo; this is how we find out whether the vaccine actually works in the real world.
What happens if you volunteer?
The first step is filling out a screening questionnaire that will help researchers figure out if you’re the kind of volunteer they are looking for. Every study has its own eligibility criteria based on things like age and health history. You can see the criteria for the Moderna trial here, at its entry on ClinicalTrials.gov.
The Coronavirus Prevention Network maintains a registry of volunteers for vaccine and antibody trials across the country, and you can sign up here.
The process of enrolling and participating in the trial will involve visits to the research center—typically 10 or so visits over the course of a year or two. These visits may involve physical exams, blood draws, and injections or infusions. Volunteers are paid for their time. The Coronavirus Prevention Network doesn’t give a specific amount, since the pay varies by study and location, but payments for long-term studies can be in the hundreds of dollars.
When you sign up for a research study—whether for a vaccine or anything else—the study will be explained to you, with a clear discussion of the risks and benefits, and you’ll be able to ask questions. You can always say no or withdraw from the study at any time.
Will people be exposed to the virus as part of the trial?
You won’t be given the virus. Studies that intentionally infect people are called challenge studies, and they’re not currently being considered for COVID-19 vaccine trials.
The whole idea of a vaccine trial, though, is to see if it protects you against the virus. The studies intend to only accept people who haven’t had COVID-19 yet; they will then wait to see whether you get it or not.
Is this a good opportunity or a risky one?
It’s potentially both. If you’re lucky, you might end up in the arm of the trial that gets the actual vaccine (instead of the placebo) and the vaccine might turn out to work. Congrats!
But you might get the vaccine, and it might turn out that the vaccine has harmful side effects. On the bright side, that’s information that the researchers should know—and perhaps your experience will lead to a harmful vaccine being scrapped, or to a better understanding of who might be harmed by the vaccine on rare occasions, and why.
Or perhaps you’ll get the placebo. There’s no way to know. You might also get the vaccine, and the vaccine turns out not to protect you. You definitely shouldn’t act like you’re protected just because you’re participating in a vaccine trial.
Trying out a new vaccine is an inherently risky proposition, and that’s the whole reason for trials—so that a treatment can first be tested on people who know what they’re agreeing to and who are under close observation, rather than rolled out to everyone before the risks and benefits are well understood.
Source: gizmodo.com
