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UC San Diego Joins Second National Clinical Trial For COVID-19

 September 3, 2020 at 10:18 AM PDT

Speaker 1: 00:00 The centers for disease control is notifying States that new vaccines for COVID-19 could be rolled out as soon as next month. Raising questions about the speed with which vaccine trials have been conducted. Meanwhile, UCS D is recruiting almost 3000 candidates in San Diego and Imperial counties for a new vaccine trial here to explain what's involved in the trial. There's dr. Susan Little, who is leading the AstraZeneca trial at UC SD. Dr. Little, thank you so much for joining us. Thank you. So tell us more about this vaccine trial and what it would involve. Speaker 2: 00:31 Well, the AstraZeneca vaccine rolled out nationally last week, starting, uh, August 28th, and we hope to begin recruitment here in San Diego next week. Uh, and in Imperial Valley, uh, probably a week or two later, uh, we'll be recruiting. Uh, I hope just over a thousand or 1500, uh, individuals in both sites. Uh, we are looking for adults 18 or older in generally good health, but underlying conditions are fine. Meaning people with preexisting diabetes, heart disease, lung disease, et cetera, are fine, as long as they haven't been hospitalized in the last three months. And in particular, we're also looking for older adults, age 65 and older. Speaker 1: 01:11 How does this vaccine work? And does it differ from others being developed? Speaker 2: 01:14 Almost all of the vaccines that are in development are using a similar, uh, approach that is they're using the spike protein of the COVID virus to elicit a, um, a response. Um, so they take a, a vector that is the vaccine construct and they embed within it a piece of the, uh, SARS virus. Um, and that just the small piece that spike protein is hoped will, um, allow the person who's been vaccinated to elicit, uh, an antibody response, a protected antibody response. So this vaccine is very similar to the others. It just uses a different vaccine platform with the same spike protein embedded within it. Speaker 1: 01:58 Are you prioritizing your outreach efforts to certain communities? Speaker 2: 02:01 We are we're prioritizing communities that have been hardest hit by COVID, which in San Diego are primarily communities of color in the South Bay and East counties. And those communities I think have the greatest opportunity to benefit, um, from an effective vaccine. Um, and for that reason, we are prioritizing those communities. Also communities of so-called essential workers, people who are at greater risk of acquiring COVID by virtue of their work, people who are exposed to COVID because they're out in the workforce Speaker 1: 02:35 And you were planning to recruit people by going to certain communities in a bus. I understand. Speaker 2: 02:40 I think that's one of the most unique features of this study is that we've, um, developed an entirely mobile vaccine clinic. So we will be taking a mobile vaccine, a mobile vehicle to certain communities, and we're going to focus on Chula Vista, Imperial beach and Lamesa, and we will be taking our, um, mobile vehicle, those locations and parking. And we will not allow walk-ups, but we will schedule people who have contacted us through our website and our phone number. Um, and we will be, um, doing the vaccinations on the bus. Um, and, um, then coming back for followup visits, uh, and we will have separate mobile vehicles for people who have acquired or believe they may have acquired COVID in the course of the study followup. So we won't be mixing people who may be infected with people who are not Speaker 1: 03:31 Now bearing in mind that the CDC is now talking about rolling out approved vaccines next month. You know, given that phase three trials have only just begun, how realistic is it to expect a vaccine by next month? Speaker 2: 03:43 I think it's unlikely. I do think we're all hopeful that a vaccine study that for instance, the modernist study, which started, um, similar to the AstraZeneca is enrolling 30,000 people over eight weeks. That study started in late July. Um, the hope is that for all of these studies, there are going to be multiple, um, that if they can recruit their target population, 30,000 people over eight weeks that maybe four, six, eight months later, um, that there will be enough end points. That is enough cases of COVID that have occurred in the study population, that they may be able to make a determination of efficacy, but four months strikes me as, uh, optimistic, um, and more likely six months. Um, so I, I think November is perhaps more politically motivated than scientifically motivated Speaker 1: 04:41 Or vaccine trials scheduled to go on for two years. So if another vaccine comes out sooner, would the trial still continue? Speaker 2: 04:47 Yes. Um, there are going to be multiple studies that are released one right after the other, um, and the goal being, uh, ideally we would have multiple vaccine studies, multiple vaccines that work multiple vaccine studies will be ongoing simultaneously all, probably two years of followup. The two years of followup is for safety. Um, and even if we find that a study is effective four or five months into the vaccine study, because we have enough study end points, the study will continue for safety reasons. Um, it is, I hope, um, uh, planned that all people who are once they find that the study is effective, people who received placebo will be given the opportunity to roll over as we say to the, to the intervention, to the actin arm. Um, but the study will continue for safety reasons. Um, but the goal is that we will have multiple vaccines that are found to be effective because realistically, if out of all of these studies, we find one vaccine that works. It will be a major challenge to vaccinate, not just the U S but the entire world with only effective vaccine. Speaker 1: 05:59 And have you at UCS D begun preparing for a strategy to roll out vaccines, the state or the County in communication with healthcare providers in San Diego about this, Speaker 2: 06:09 There is a national effort already to try and discuss equitable access and distribution of vaccine. So, um, certainly medical providers that are involved in the vaccine leadership within the vaccine studies and national leaders are working right now to develop policy so that when an effective vaccine does become available, there is, um, policy in place across the United States that we hope will help ensure equitable access and distribution of the vaccines. Speaker 1: 06:43 So, dr. A little, how can people sign up for your trial where I've been working? People get more information Speaker 2: 06:49 I've seen website is COVID vaccine SD COVID vaccine st com. Um, and they, once they go to that website, it is in English and Spanish. Um, they complete a short survey, um, that, uh, prioritizes helps us to prioritize our, the speed with which we respond to individuals. Um, and there's also a phone number (619) 742-0433. Um, if people don't want to use the website, um, and this, um, website will be for all future studies that, that I lead in San Diego. So there will be others that are coming shortly after this AstraZeneca study. Speaker 1: 07:27 Dr. Little, thanks so much for your time. Speaker 2: 07:29 Thank you very much. I appreciate the opportunity. Speaker 1: 07:31 We've been speaking with dr. Susan Little who's leading the AstraZeneca trial at UCS.

UC San Diego Health announced Wednesday it will join a second, national clinical trial to develop a vaccine designed to protect against SARS-CoV-2, the novel coronavirus that causes COVID-19, by the end of the year.
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