DENVER, Colorado — Preparations are still needed before researchers at the University of Colorado School of Medicine and UCHealth on the CU Anschutz Medical Campus can begin a study testing a COVID-19 vaccine candidate.
In early July, UCHealth announced researchers were looking for 1,000 Colorado patients for the Moderna vaccine trial.
The patients would be monitored for at least a year to determine the vaccine's safety and efficacy.
At the time of the announcement, UCHealth told 9NEWS recruitment would last about two months.
Dr. Thomas Campbell, an infectious disease physician at the CU School of Medicine, told 9NEWS they have started outreach but not recruitment.
"We have received a lot of interest; we already have close to 100 people who have stepped forward and said, 'I want to volunteer for this study,' Dr. Campbell said.
We took our questions about the behind the scenes preparations to Dr. Campbell.
(Editor's note: Responses have been edited for context and clarity.)
9NEWS: How are you involved with this study?
Dr. Thomas Campbell: The Moderna vaccine trial is a very large, what we would call, phase III clinical trial to evaluate this vaccine to see if it's effective and safe at preventing COVID-19. The study is being conducted around the country at many sites, close to 90 I believe. We are one of those sites here at the University of Colorado Hospital.
What is the process like to get a clinical trial off the ground?
Dr. Campbell: There’s a lot of work that goes into getting a clinical trial off the ground, particularly a clinical trial of this scope and magnitude. Of course, we have to make sure that we have the proper personnel, the proper facilities, that our personnel has been trained, and are ready to do the study. That’s one piece of it. Another big piece is we have to go through a regulatory process to ensure we’re doing the study correctly and safely. There are institutional review boards and bio-safety committees that have to review the study, review our site, and make sure everything is in place so that the trial is conducted to the standards that are needed.
Are you hiring new staff for this study or focusing on training?
Dr. Campbell: We have a core group of very experienced research staff who will be working on this study. The magnitude of the study, the work that we need to do for the study, will be beyond what our current staff can accommodate. So, we are also in the process of hiring additional staff.
What kind of response have you gotten in talking to individuals about participating?
Dr. Campbell: We have not started recruiting yet. Let me make that perfectly clear. We have started outreach. We have been reaching out to our patients in UCHealth as well as patients in other community groups. Although we intend to recruit heavily from UCHealth patients, we are not restricting the study just to UCHealth patients. It is available to other members of the Colorado community. We have received a lot of interest; we already have close to 100 people who have stepped forward and said, 'I want to volunteer for this study.' In the coming days, we will be sending out requests for more information to certain individuals, and then as soon as we are authorized to begin enrollment, we will. I don’t know exactly when that will be but I anticipate it will be soon.
Who are you looking to recruit once you start the process?
Dr. Campbell: We are very much wanting to recruit people from groups that are most affected by COVID-19 in our community. So, we do want to make sure that we recruit people who have health issues such as diabetes or obesity or chronic illness that puts them at risk for getting sick from COVID-19. We want to recruit people who are, because of their occupations or because of their living circumstances, at risk of getting infected with SARS-CoV-2. We want to recruit people who are disproportionately affected by COVID-19. In Colorado, people who are Hispanic, African Americans, Native Americans, are disproportionately affected by the COVID-19 illness. It’s important that we have representation from all of those groups in our study in order to make it a valid study. That will then inform how we can use the vaccine if it’s proven to be safe and effective.
In your outreach, have you found that people are wary of the trial?
Dr. Campbell: I’ve heard a number of things from people in the community. Number one, there are people in the community who are skeptical about vaccines in general. Number two, I’ve heard from some community members that they’re concerned about the rapid pace that this, not just this vaccine, but all vaccine programs related to COVID, are progressing at. It’s obviously very important to do that because we have an ongoing pandemic and it’s important to develop the tools that we need to fight the pandemic. It’s important that we do these studies both to know that the vaccine is safe and effective. What I would say to those people is, ‘yes, we do have a very accelerated pace but we’re not compromising safety by following that pace.’ We’re moving fast but we’re moving safely.
How critical is safety in this process?
Dr. Campbell: There’s a lot of emphasis on making sure this vaccine is safe. What’s very important about this and other upcoming related vaccine studies is that they are enrolling very large groups of patients from very diverse communities across the entire country. As I mentioned, the Moderna study will enroll 30,000 people across the country. There are other studies that are coming for other vaccines that will enroll similar or even larger numbers. That will enable us to really get a very good idea about how safe the vaccine is, whether or not it is safe. Let me say right now, we don’t know if it’s safe. The data so far suggests that it is but that’s the purpose of the study. That’s why this is a research study, we need to determine the safety. When the research study is complete, then we will be able to say whether or not the vaccine is safe. That applies to all vaccine studies as well as other drug development studies.
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