A team of physicians at the University of Miami's Miller School of Medicine have a research study underway on one of the COVID-19 vaccine trials — and they need volunteers.
The trial will determine if the investigational Janssen vaccine can prevent symptomatic COVID-19 after a single dose.
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Eligible volunteers must have not had COVID-19 and will be followed for two years. People who are interested should email Janssencovidvaccine@miami.edu or call 305-243-0952.
Dr. Dushyantha Jayaweera, a professor of medicine and principal investigator for Janssen’s UM site, spoke with WLRN’s Verónica Zaragovia.
This vaccine uses the adenovirus. It’s a virus that can cause the common cold. Help us understand how this vaccine works.
How the vaccines work is that we do genetic engineering and we put little bit of coronavirus gene into this. We inject this, so that now the immune system thinks that the coronavirus is here and then the body develops antibodies. These are like the soldiers who kill anything that comes in, and so they generate those cells that will learn the virus.
That’s how next time the real virus comes, the antibodies will attack the virus and get rid of them. That's the most important thing that they should be able to neutralize the viruses coming around. So they can be like the foot soldiers of our immune system.
You recently had to pause your study and now you’re moving forward again. What makes it safe to continue?
The pause is because one of the patients had a serious adverse events and based the way the protocol is written, immediately there is a pause of the study, and now the pause has been lifted. I’m very comfortable to continue with the study as we have been cleared to continue as it is safe.
So you feel confident that people should volunteer?
We all felt that we should have more information. And what the sponsor has said, which is very good, is that the data has been seen by the National Institutes of Health expert panel of vaccine experts across the world, it has been seen by the Data Safety Monitoring Board, the data has been presented to the FDA and the consensus among all of them were that it was safe to continue.
So that gives me great deal of confidence that this study is safe to continue and that that adverse event will not stop us from going ahead with the study.
What can volunteers expect?
If you qualify, and if you give informed consent, we vaccinate you, and we also give a lot of equipment to take home so that you can monitor yourself. You have to come eight times over two years and you're compensated for your time, your travel.
Everything will be compensated, and we also give a lot of equipment to take home so that you can monitor yourself. But I have to emphasize that this is a placebo-control study. That means 50 percent will get the vaccine. Fifty percent will not get the vaccine.
"So why should I take part in a vaccine [trial]? Why don't I wait till it is approved?" The answer to that is that if people don't take part in it, then we cannot get the vaccine approved. Because if everybody waits for somebody else to do it, studies will never be completed.
We are in constant contact with the patients through the cellphone and face-to-face meetings. and the slightest problem, we will come and see you at home and we will bring you to the hospital. If there's anything [that] goes wrong, we will make sure that you get the best possible medical care that we can offer.
How do you plan to attract volunteers who are Black and Latino?
There's a general principle about doing clinical trials. The participants in a clinical trial should reflect who [is] in the community, the proportion of people who are in the community. So if the community has 15% African-Americans, 60% Hispanics, then the study should reflect something very close to that.
We specifically want to focus on the people who are at risk for coronavirus, which are the minorities and the African American and Hispanics and people with comorbidities, and it is really important that people over 65 with comorbidities volunteer for the study so we can quickly finish our recruitment and come up with the meaningful result.
The reason why we need a diverse population in a study is part because of the genetic makeup of different people are different, although all human race is the same. There are subtle differences, and we want to pick these up very early so that we can study that and make the appropriate adjustments. Science develops based on the needs of the public and the community.
Why did you get involved in this study?
Necessity is the mother of invention, and this is exactly what is happening. There is a huge necessity to come up with a solution and now we do the invention to mitigate the problem.
I think I’ve been working from HIV and Hepatitis C for a long time. The beauty about this research is that you answer questions that you don’t know the answer, and you do big public, great community service by what we do. And if we can save lives then it’s worth it.
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