When Karen Tibbals of Washington, NJ learned that it would take more than 100,000 volunteers for late-stage clinical studies of four COVID-19 vaccines, she wanted to roll up her sleeves and take one of the experimental shots.
Tibbals is 65 and has the autoimmune disease of rheumatoid arthritis, which increases her risk of serious complications from COVID-19. But she also brings a unique perspective to the race to develop a vaccine: Tibbals is a retired pharmaceutical marketing manager who has seen the clinical trial process up close during stints at Novartis NVS,
and Merck. MRK,
Some of the coronavirus vaccines involve delivering pieces of genetic material from the virus to induce the body to launch an immune response – emerging technology that has not been widely deployed before. But that doesn’t scare Tibbals.
“I have a chance to help other people”
“This is really cool new technology; I trust it. I have a chance to help other people, ”said Tibbals, adding that she is confident that the companies will follow procedures for safe clinical trials. She volunteered to participate in the site trials for the COVID-19 Prevention Network (COVPN), an initiative of the National Institute of Health’s National Institute of Allergy and Infectious Diseases.
COVPN manages the recruitment of volunteers for clinical trials of vaccines developed by AstraZeneca AZN,
, Moderna MRNA,
and the Johnson & Johnson JNJ,
Janssen unit. The Moderna trial started in July, while the other three trials started between August and December.
You may also be interested in participating in a clinical study with COVID-19. You should know this:
Each company needs about 30,000 volunteers for its studies, and more COVID-19 vaccine developers could be added if their products advance to late-stage clinical studies, said Michele Andrasik, a scientist in the vaccine and infectious diseases department at Fred Hutchinson Cancer Research Center and one of the community outreach managers for COVPN.
Who the vaccine developers want
The developers of COVID vaccines are primarily interested in recruiting clinical trial participants who are considered most vulnerable to COVID-19, Andrasik said.
“People with pre-existing conditions are a priority population, as are adults over 65 years of age,” she noted. African Americans, Native Americans and Latinos also have a high chance of being admitted to a vaccine trial. This also applies to people who are most likely to contract the disease because they work in healthcare facilities or in open workspaces, such as meat processing plants.
However, some people may not qualify for the vaccine trials because of drugs they use to treat chronic diseases or other factors.
But because of the large number of participants that will be needed, Andrasik said, anyone interested should sign up. “For example, even if someone is not eligible for the Moderna trial, they may still be eligible for a future trial,” she said.
Before signing up, however, you should know what holding a COVID-19 vaccine trial entails.
The chance to get a placebo
First of all, don’t assume you can throw your mask away and stop social distances after taking the photo. These studies will be placebo-controlled. That means each participant has a 50-50 chance of getting a fake injection instead of a real vaccine.
In fact, the vaccine developers are counting on some subjects actually getting sick with COVID-19, Dr. Richard Novak, professor of medicine and head of the department of infectious diseases at the University of Illinois and one of the clinical trial investigators for Moderna. All participants are warned that they can get the coronavirus.
“We don’t expose or give people COVID-19, but we do need to find people at high risk to get it,” said Novak. That way, the companies can compare infection rates between people who got the vaccine and those who didn’t.
The protocol for each study will vary slightly depending on the company and the vaccine being tested. However, all volunteers selected for a trial are expected to personally complete the enrollment process at one of more than 80 sites conducting the trials.
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Clinical trial volunteers will be asked to sign “informed consent” documents stating that they understand that they can receive a placebo and that they may experience side effects if they receive the vaccine.
Possible side effects for participants in the COVID-19 vaccine study
What kind of side effect? Sore arm, low fever and muscle pain – the typical side effects of all vaccines. Moderna said chills, headaches, and fatigue were also reported in her 45-person trial of the vaccine.
Patients in the studies are likely to receive some compensation to cover their time and basic costs. That depends on the location and the trial sponsor.
Participants are followed by phone calls and further visits to the research sites.
For example, Moderna’s trial is likely to require about seven follow-up visits, weekly phone calls, and electronic journals that participants are expected to complete, Novak said. “If they develop symptoms that are consistent with COVID-19, we bring them in or go home in between, collect samples and monitor them to see how they are doing,” he added. (Moderna did not respond to requests for details on the study protocols.)
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While Moderna’s entire process will take two years, Novak estimates, the frequency of personal contact between participants will decrease over time, to once a month or possibly less.
Despite the urgent demand for COVID vaccines that work, trial volunteers don’t have to worry about cuts in safety, said Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University.
That’s because clinical studies always have data safety monitoring boards, panels of independent experts with access to information on how the people who receive the actual vaccines fare compared to those who receive placebo.
“If side effects of a certain severity occur in the vaccinated group, but not in the [placebo] the trial can be stopped, “says Schaffner, who is not involved in the COVID-19 studies.
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Or if the Control Board looks at the interim data and finds that the vaccine is unlikely to effectively prevent the disease, it may end the trial, “because there is no need to recruit additional volunteers and expose them to a vaccine that doesn’t work, “Schaffner said.
By the end of July, more than 154,000 people had volunteered to participate in the COVID-19 vaccine trials through the COVPN website. People interested in volunteering for trials not listed there can also find opportunities by visiting Clinicaltrials.gov and search for the keyword COVID-19.
Tom Smith, a 62-year-old technology research analyst in Raleigh, NC, is eager to participate in a COVID-19 vaccine trial, even though he knows it will be a source of anxiety for some of his family members – especially his 87 year old father.
“They would be very wary if I did this,” said Smith. “But you have to have people who want to test the different technologies. I want to do everything I can to help. ‘