Lifespan is looking for 300 to 400 adults to participate in a clinical trial at The Miriam Hospital in Rhode Island for a coronavirus vaccine. Health Reporter Lynn Arditi talked with Dr. Karen Tashima, the infectious disease physician who will lead the trial, about who they need to recruit and why. (The interview has been edited for length and clarity.)



Why are you starting to recruit volunteers for a vaccine trial when Lifespan is still waiting to hear about whether it has been selected? 

We've been prepared since about July or August for possibly hearing that we would become a vaccine study site. And this is part of Operation Warp Speed, the federal government's response to try to find a vaccine and other treatments for coronavirus. So we are an established NIH funded site. We've been doing HIV research for many years. So we were naturally part of the clinical trials research sites that would be considered for a vaccine trial. We've been given some funds to get Rhode Island prepared to participate in the vaccine study.

How much funding does Lifespan have for this effort?

The timeline is about eight to 10 weeks to recruit the entire entire population for the studies. So we were given a grant of $250,000 to hire additional research staff and do training and research and to establish some collaborations around the state.

 Other than being 18 or older, are there any other requirements to participate in this vaccine trial? 

It is very dependent on the specifics of the vaccine trial’s protocol. Most studies include participants who are generally medically stable. We are looking for people who have some underlying health conditions --  hypertension, diabetes, obesity -- and people who are 65 and older. Also we are focusing on anyone who might come into contact with COVID-19, such as front-line employees. 

Nationally, more than half of the coronavirus cases have been among black and Latino people. But as of late August, only about 10% of the 350,000 people who had registered online for a coronavirus clinical trial were black or Latino. As you prepare to lead a vaccine trial, does that worry you?

 Sure, that's going to create a big challenge. So far what we've seen, though, is that the Moderna vaccine trial has enrolled approximately half the participants are not white. So I think that the vaccine trials are doing pretty well. The studies are monitored in real time for ensuring that enough minorities are represented.

Why is it so important from a clinical standpoint to recruit minority volunteers for these vaccine trials when we're talking about creating a vaccine for a virus that has disproportionately impacted people who are minorities?   

We do need to test the vaccine and the populations that were most affected by coronavirus. And since minorities were disproportionately affected, we need to be able to say with confidence that the coronavirus vaccine is safe and effective in the minority populations. So it is critically important. We don't want to have to try to create this data after the vaccine is available.

So how do you respond to people, particularly in the minority community, who are fearful about getting sick or having serious side effects from a trial vaccine? 

I think most people are somewhat fearful of getting something new, a new vaccine. But we need to make sure that everyone understands that the science is going to be behind it. The data will speak for itself in terms of the safety and effectiveness in terms of the minority communities. Part of my efforts are going to be to reach out to providers in the community medical providers, and they can also give the correct messages to their patients and encourage them to participate if they would like to.

What specifically will Lifespan be doing to solicit volunteers and underserved minority communities? 

Lifespan is initiating a social media campaign to promote the vaccine registry website. Specifically in minority communities. Dr. Martha Sanchez, who is a Spanish speaking physician originally from the Dominican Republic, has gone on the radio talk show with Dr. Pablo Rodriguez, to discuss COVID-19. I'm also collaborating with Dr. Michael Fine, the former state health director, and the City of Central Falls. Dr. Fine’s had the idea to hire community outreach workers who will go door to door and speak about masking, appropriate social distancing as well as this potential vaccine and participation in a vaccine study. 

Some people might fear that they can contract the coronavirus from the vaccine. But since these are not live vaccines of the virus itself, is that a risk?

None of the vaccines that are being tested currently in the US contain any live virus, only a small portion of the virus, but not enough to allow the virus to multiply in the body.

Do you know which of the phase three trials Lifespan might participate in?

The one’s I've heard were in consideration are the Novavax trial and the Sanofi trial. So it depends on the timing of the two trials. But I expect that we would only participate in one trial.

And when do you expect to find out which vaccine trial Lifespan will be chosen for?

Any day! I'm anxiously awaiting to hear positive news that we'll be able to participate in the vaccine trial.

Related coverage: Lifespan recruiting volunteers for COVID-19 vaccine trial

--Health Reporter Lynn Arditi can be reached at larditi@thepublicsradio.org