- More than 100 clinical trial sites at hospitals and medical clinics across the world will be testing potential COVID-19 vaccines.
- COVID-19 vaccines in trials do not give recipients the virus.
- Mild side effects from the vaccines are possible, but usually last only a few days.
One way to help with the pandemic is by participating in a vaccine trial for the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), which causes COVID-19.
“If we’re going to see the end of the COVID-19 coronavirus pandemic, we need a vaccine to prevent disease and keep those infected from infecting others, which is why it’s important for people to participate and volunteer,” Dr. Richard Novak, chief of the division of infectious diseases at the University of Illinois at Chicago College of Medicine, told Healthline.
Novak is in charge of recruiting 1,000 volunteers for the first late-stage vaccine trial lead by the biotechnology company Moderna.
“We’ve had a lot of support already. People appreciate that this is very important and our way out of the pandemic,” he said.
The Moderna study at the University of Illinois at Chicago is just one of more than 100 clinical trial sites at hospitals and medical clinics across the world.
The Fred Hutchinson Cancer Research Center is the coordinating center for vaccine clinical trials of the COVID-19 Prevention Network (CoVPN), which is funded by the National Institute of Allergy and Infectious Diseases.
Stephaun Wallace, PhD, director of external relations at the CoVPN, says the network will work to develop and conduct studies to ensure rapid and thorough evaluation of vaccines and antibodies for the prevention of COVID-19.
“History has shown us how a safe and effective vaccine can eradicate a disease. This is a similar undertaking in which communities can all be part of. We are conducting COVID-19 vaccine trials that are inclusive of all communities, and with a focus on communities who are at higher risk for COVID-19,” he told Healthline.
If you’re interested in participating in a trial, here are few things to consider.
Once interventions for disease show promise after being studied in labs and animals, they are then tested on people in clinical trials.
However, Novak says a common misconception about prevention vaccines is that they can give people the virus. In fact, he says, the kind of study that gives a person the disease is called a challenge study. COVID-19 vaccine trials use a design known as “randomized, blinded, placebo-controlled” studies, in which people who are more likely to be exposed to SARS-CoV-2 infection and COVID-19 illness are enrolled.
“You cannot get an infection from a vaccine because vaccines do not contain a whole living virus [or killed virus], so there is no way it can give you the disease. We hear this a lot with why people don’t get the flu vaccine, but it’s not true,” said Novak.
For the Moderna study, he is selecting those who are at risk of getting the infection, such as people 65 and older, those with underlying health conditions, or those who live in communities largely affected by COVID-19. People who fall into these categories are at high risk of getting the virus.
Because it is not known if the vaccine is effective, it has to be done in a randomized controlled trial. This means that without knowing what group they fall into, some participants are randomly assigned to receive the vaccine while others will receive a placebo, which is a substance like sterile salt water that does not have any active ingredients.
“This is a double-blinded trial, which means that the people [conducting] the study like me, and the participants don’t know what they are getting. That makes it completely objective and there will be no bias,” said Novak.
To determine if the vaccine works, researchers compare the two groups to see if there are fewer people who get sick in the vaccine group than in the placebo group.
“People who get the vaccine, in the end, we hope that they’ll be cured for symptomatic COVD-19 symptoms compared to the placebo,” said Novak.
To ensure the safety of the trials, Wallace says scientifically rigorous clinical trials will be coordinated and closely monitored by an independent oversight Data Safety and Monitoring Board that meets every 6 months to review study data.
“Local Institutional Review Boards, a group of experts, help to protect the rights and welfare of study volunteers recruited to participate in the trials,” said Wallace.
Most studies will have potential participants answer a questionnaire about their medical history. They also may conduct a physical exam to measure a volunteer’s weight, temperature, blood pressure, and more to help determine their eligibility to enroll. A blood sample for lab tests may also be taken.
If selected, most studies require about 10 on-site visits from participants over a 1- to 2-year period. The visits might involve getting injections, drawing blood, and talking with researchers.
For the Moderna trial, volunteers will be followed for 2 years and asked to keep an electronic diary indicating how they feel and tracking any symptoms they have. They are also required to be available for weekly check-in phone calls.
“Study staff will [talk with participants] to acquire information. We want to know if the vaccine is effective and how long does it work for. Some people will get infected with COVID-19, but they might not get sick because they had the vaccine or they may have mild symptoms or be asymptomatic. If volunteers do show [signs of COVID-19], they check in with us and we either bring them in or go to their home to test them for COVID-19,” said Novak.
Study participants often receive payment, which varies depending on the length and number of visits as well as city the study takes place because of differences in the cost of living. Details about compensation are revealed before participants commit.
Novak said participants will receive compensation for taking part in the Moderna study, however, the amount is not known yet.
“The local Institutional Review Board helps make determinations on the amount each study participant will receive,” said Wallace.
The CoVPN states that vaccines often have side effects, such as sore arm, low fever, and muscle aches and pains. However, the side effects typically go away after a day or two.
Novak notes that about 1 percent of participants will experience a reaction.
“It’s not unusual to [have reactions] from a vaccine because we are trying to generate an immune response, and so you might get an inflammatory response,” said Novak.
Before participating in a study, all volunteers go through a process called informed consent to ensure they understand all the risks and benefits of being in the study. If at any time, a study participant wants to leave the study, they are able to without losing any of their rights or benefits, according to the CoVPN.
If you are 18 years old or older and would like to sign up for a vaccine trial in your area, visit the CoVPN Volunteer Screening Registry.
After filling out a short survey, your information will be provided to a study site closest to the area you reside in. If the study site thinks you may qualify for a particular study, they will reach out to you either right away or in several months, as there are many studies taking place throughout 2020.
Take note that study facilities will never ask for financial information, such as your credit or bank account information, or for your ID number over the phone.