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This week, the inaugural phase 3 trial for a COVID-19 vaccine commenced, aiming to recruit 30,000 participants by its conclusion. Additional phase 3 trials are expected to follow shortly. While the global community eagerly anticipates a safe and effective vaccine, its success hinges on volunteers willing to test it.
Vaccine trials, similar to drug trials, are conducted in three stages. The initial phases determine the correct dosage, assess side effects, and confirm the vaccine triggers an immune response. The final phase, described by physician scientist John Cooke as 'the definitive trial,' involves a large group of participants receiving either the vaccine or a placebo to evaluate its real-world efficacy.
What to Expect as a Volunteer
The initial step involves completing a screening questionnaire to determine if you meet the criteria researchers are seeking. Each study has specific eligibility requirements, such as age and medical background. For instance, the Moderna trial's criteria can be found here, on its ClinicalTrials.gov listing.
The Coronavirus Prevention Network offers a nationwide registry for volunteers interested in vaccine and antibody trials. You can register here.
Enrolling in a trial typically requires multiple visits to a research center—around 10 visits over one to two years. These appointments may include physical exams, blood tests, and injections or infusions. Volunteers are compensated for their time, with payments varying by study and location, often reaching hundreds of dollars for long-term participation.
Upon joining a research study—whether for a vaccine or another purpose—you’ll receive a detailed explanation of the study, including potential risks and benefits. You’ll also have the opportunity to ask questions and can withdraw from the study at any time.
Will participants be intentionally exposed to the virus during the trial?
Participants will not be exposed to the virus. Challenge studies, which involve intentional infection, are not currently planned for COVID-19 vaccine trials.
The purpose of a vaccine trial is to determine if the vaccine provides protection against the virus. These studies typically recruit individuals who have not contracted COVID-19 and monitor whether they become infected.
Is this a beneficial opportunity or a risky endeavor?
It could be both. If you’re fortunate, you might receive the actual vaccine (rather than a placebo) and it could prove effective. Congratulations!
However, there’s a chance the vaccine might cause adverse effects. On the positive side, this information is crucial for researchers—it could lead to discontinuing a harmful vaccine or identifying rare risks and their underlying causes.
Alternatively, you might receive the placebo, and there’s no way to predict this outcome. Even if you get the vaccine, it might not provide protection. It’s crucial not to assume you’re immune simply because you’re part of a vaccine trial.
Participating in a new vaccine trial involves inherent risks, which is precisely why trials exist—to test treatments on informed volunteers under close monitoring rather than releasing them to the public before fully understanding their risks and benefits.
