Tour the Special Clinical Studies Unit with Dr. Matthew Memoli

Hello! Welcome to the Special Clinical Studies Unit at the National Institutes of Health; come on in.

My name is Matthew Memoli; I'm the Director of the Laboratory of Infectious Diseases Clinical Studies Unit and I'm going to talk to you a little bit today about our Special Clinical Studies Unit here at the NIH Clinical Center.

So this is a hospital unit that was designed specifically for certain uses here in the NIH Clinical Center, which is the NIH's hospital. This unit is specially designed for two primary purposes. The primary purpose number one is that this is a unit where patients with special rare or unusual diseases that require high containment can be cared for without risk to the community or other patients in the hospital, so this unit was designed in a way so that these infections or microorganisms that people may carry with these diseases can be contained. The other reason we use this unit is for special clinical studies--clinical trials that are unique in some way that require either containment or a special area for the participants of those studies where procedures can get done or certain types of special tests and things that need to get done are able to get done efficiently.

Sure, so right now we're in the staff entryway of the Special Clinical Studies Unit. The door that you came in with me is the staff entrance. Over here on my left is the nurse's station; so this is where the nurses spend their time when they're not actually in the room caring for the patients. They have computers here where they're able to access the different medical information they need for the participants, orders for medications, and other procedures. They have access to monitoring screens where they can monitor the participants' or patients' vital signs and EKG tracings and things that are being monitored, and also an area for them to keep supplies and spend their time when they're not in the room. Over on my right here is a special common area. This is an area that's primarily used during the clinical trials that I mentioned. People who stay here for those clinical trials, sometimes they spend a week or more here in the unit, and so rather than having to be isolated just to their room, they're able to use this common area to interact with other participants in the study. We also have entertainment for them in terms of video games and movies, television, there's also a small kitchen for them. We also sometimes use this room in our clinical trials in that sometimes there are activities that participants need to participate in together, and we're able to use this room for those types of activities or procedures that we perform during those studies.

That's right. So behind me is the main part of the unit; we'll be going into there in a few minutes. In there are patient rooms; there's five patient rooms in there that can hold up to seven patients. Those rooms are able to house individuals either separately or in groups of two, except for one room. All of those rooms are isolated from the rest of the unit in terms of airflow. So one of the special features of this unit is the airflow and that it's something that we call negative pressure and that as you move into the unit, all of the air is being sucked into the unit, none of the air moves out of the unit. So as we moved into the door that you came through, the air was being sucked in; if we were to go through this door, the air is then sucked into the unit, and so on and so forth into the patient rooms. So patients can be housed in those rooms carefully so that the air that they're breathing is not then shared with other patients of the unit or outside of the hospital. That's also true for this common area; it's negative pressure to this area, so as you move through, all of that air flow is carefully monitored and maintained. Beside this common area, and the patient rooms, we also have a small exercise room that can be used in certain studies, but oftentimes in our clinical trials the patients aren't able to use that. There's also an area for laundry, we have an area where the nurses keep their medications and supplies, as well as a locker room where the staff that takes care of patients with very contagious or dangerous diseases are able to prepare to enter the unit and take care of those patients.

Sure; let's go in and take a look at that.

So as we move through the unit, we always want to maintain our hand sanitation, so we use this hand sanitizer as we move into different areas of the unit.

So patients with rare diseases that are highly contagious are treated here in the Special Clinical Studies Unit. We have a special staff that's trained to do that; they're an excellent team of doctors and nurses who keep up their training on a regular basis so they're prepared at all times for those patients to be transferred here. In the past they've taken care of multiple Ebola patients here in this unit. Kim is one of the nurses from that team; she's wearing some of the equipment that the staff uses when taking care of patients with those diseases, such as Ebola. What you see here she's wearing a Tyvek suit, which is the white suit underneath the blue coverup that she's wearing on top. She has booties covering her feet, as well as multiple sets of gloves covering her hands, and she's wearing something called a 'PAPR' or powered air purifying respirator. This is made up of this helmet that connects to a battery pack, and then has this hood that goes on top of it that covers up her face and neck and completely contains the air that she's breathing. This is a filtered system that's maintaining the cleanliness of the air that she's breathing as she's able to take care of these patients with contagious diseases. The staff typically would don and doff this equipment with someone called a Watson, who watches them to make sure that they're putting on the equipment properly and not missing anything that they're supposed to be doing, and also making sure there's no tears or rips or problems with the equipment. They also have a locker room behind us that they're able to enter and exit through, and after taking care of one of these patients they would typically go through and shower before putting on their clothes and then leaving the unit, and this maintains the safety of both the patient, the nurse or the doctor, the staff, as well as the community at large and the rest of the individuals in the hospital.

So all waste and air is handled separately for this unit, so as I was mentioning earlier, the air is specially handled so that this air is not recirculated throughout the rest of the hospital, in fact it's not even recirculated amongst the patients here in the unit. It's a single pass air system, where the air comes in and then goes out immediately through a filter, maintaining, again, safety to the outside. In terms of the waste, essentially the same system in that all of this waste is handled separately from the rest of the hospital. It has to go to a special septic system and all of the medical waste, as well as patient waste, goes through an autoclave system, which you can essentially think of as a pressure cooker that heats up under high pressure and sterilizes that waste before it's able to leave the NIH.

Sure. So other than taking care of patients with highly contagious diseases we do special clinical studies. This is primarily what I do here; I run a number of those trials that are done in this unit. Some of those trials are sort of these special trials that we call challenge trials, where we take healthy volunteers who decide to come here to participate in these studies, and we actually infect them on purpose with respiratory viruses such as influenza or RSV. I particularly run the influenza trials, we've done multiple trials where we've given completely normal influenza--the flu, like you would get walking around on the street, to healthy individuals to try to get a better understanding of what happens when people are infected with flu. What we're particularly interested in is understanding how people's bodies respond to flu--their immune system--and what protects them from flu, because as we give the virus to some people, some people get sick and some people don't, and we can learn a lot from that, and that trying to understand what keeps people from getting sick can help us to design better vaccines in the future that could protect people against the flu. And much of the work that we've been doing has been very helpful in that regard, and we're actually now getting to the point where we're starting to test some of the new vaccines in this system, where we can test vaccines against the flu with a smaller number of people than a typical community trial, and we can do it before a new pandemic or a new epidemic flu virus appears in the community. And so we use this unit for those trials because the patients have to spend a week or two weeks here in the unit as an inpatient, and we're able to contain them here, as well as give them opportunities to be able to move around and not sort of be stuck in their room the whole time. Also we do some unusual other kinds of trials here, and because the staff is so specially trained they're able to help us with that. One of the other types of trials that we've done recently was a trial looking at a mosquito-borne disease vaccine. This vaccine was a vaccine designed against mosquito saliva, so not a disease itself, but the saliva of mosquitoes, and so in order to test whether the vaccine was working we needed to have people exposed to clean mosquitoes--mosquitoes that don't carry diseases. So again we had healthy volunteers who came to this unit we gave them the vaccine, and then a certain period of time after we gave them the vaccine, we actually had them hold put their arm down on top of a cup containing these mosquitoes that then bit them, so that we could get an understanding if their body was responding to the mosquito bites the way we wanted them to after receiving this vaccine. And the idea behind this vaccine is that it could modify your immune system in a way that when you're bitten by a mosquito or an insect that it could protect you, this modification of the immune response would protect you against viruses or other diseases that the mosquito may carry, such as dengue, Zika, or malaria. And so because of the uniqueness of this type of trial, this unit is a really great place for us to do these kinds of studies.

Let's go right in here.

So this room is a very special room on the unit; this is the room where the sickest patients would be taken care of. This is where the Ebola patients--at least two Ebola patients were taken care of in this room. This room has an anteroom; not all of the rooms have this room. This is an extra room that is available for the staff to be able to prepare whatever they need to go into the patient room, so that they're not fumbling around with equipment when they're actually with a contagious patient, so after they've donned and doffed their equipment they're able to come into this room, prepare whatever they need, and then move into the patient room. And again, remember there's negative airflow, so as we moved in the air was being sucked in, and as we move in this door the air will also be sucked in that way.

So this is one of the patient rooms. Most of the patient rooms look fairly similar to this. As you can see, it's not that different than probably what you're familiar with in terms of a hospital room, but we do have some special features of this room. We have a monitor here that's for cardiac monitoring, we're able to do continuous cardiac monitoring. We actually have a camera system installed into the rooms because patients that have highly infectious diseases you want to limit contact with them as much as possible, so the nurses are able to monitor patients using a camera system if necessary, and we also have systems of communication with the patients so that they don't have to be in the room for every single communication. We also have TV and computers built into the monitors in the room, both for those individuals who are staying here who are sick, but also our participants in those clinical trials that I mentioned, who sometimes have to spend one to two weeks here, obviously enjoy some of the in-room entertainment that we have. We also have... these rooms are specially designed so they can be cleaned very easily, including the bathrooms, so you'll see everything can be cleaned and carefully disinfected after patients leave these rooms, whether it be for an influenza challenge trial or a disease that requires high containment like Ebola.

So the clinical trials that require participants to stay here, generally they're allowed to bring in most things that they'd like to, to keep themselves occupied. They bring in their computers, cell phones, we have Wi-Fi in the building here, they're able to bring books, sometimes they bring their schoolwork or their work, they are able to generally wear their own clothes, things like that. As long as it's not something that would bother the other individuals here in the unit, they're usually allowed to bring it in, or if it's not going to interfere with the trial, of course. The participants generally stay here, as I mentioned, for a week to two weeks, depending on the study they're doing, and they are able to watch movies, access computers, and keep themselves occupied. Generally, most of the activity happens in the morning or in the evening, where blood's being taken, sometimes they're sampling being taken from the nose, oftentimes we have them filling out questionnaires about how they're feeling or asking them other questions that we need to for our research. The patients are able to order food, generally, when they want to during the day, and the food is brought to them here in the unit. They're not able to leave this unit, because once they are infected with, say, a flu virus or respiratory syncytial virus (an RSV), they could be infectious to other individuals, so we require them to stay in this unit until they're no longer contagious. For the flu trials that's generally nine to ten days that we keep them here. And so they're able to stay in their room but they're also able to access that common area that I showed you earlier, where they can access the larger TV and the video game systems and movies and things like that.

So generally they're not allowed to have visitors come. Most patients that are staying in here, whether it be because they are sick with a special disease, or they're part of a clinical trial, they are then infectious with one of these diseases, so we don't allow visitors to access the unit. The only people who are allowed to access the unit are staff who are specially trained and have been given access to this unit.

So most of the clinical trials that we do here in the Special Clinical Studies Unit are healthy volunteer trials. We have a healthy volunteer program that you can find on the NIH's website. The phone number is 1-800-411-1222 if you're interested in these trials you can call that number and ask to participate in a healthy volunteer trial. If you're particularly interested in my influenza trials, or any of the other trials that have been done in the Special Clinical Studies Unit, you could specifically ask for influenza, or an RSV trial, and they will put you through to the correct person who will ask you some questions, and then get you scheduled for a visit here at the NIH.

So we have a code system and we would respond to that code appropriately if a patient has a disease requiring high containment, like Ebola, then that response is going to be from the actual team that I mentioned, the special team of nurses and doctors who have been specially trained to take care of those patients, and they are going to have to carefully put on their equipment and do what is necessary to take care of that patient. In terms of our special trials such as the influenza trial or RSV trial or some of these other studies that we do in the unit, that would typically be responded to by our normal code team, which is the hospital code team, all of the staff in the hospital are trained for respiratory precautions for diseases like influenza or RSV so they can easily come to the unit and do what is necessary.

So influenza is spread, obviously, in the community. We actually are still trying to understand fully exactly how. We believe that it can be spread multiple ways--one, through what we call aerosol transmission, which means you breathe it in, but we also believe it's possible that you could acquire influenza through contact, meaning someone coughs or touches an object, and then you potentially touch that same object and pick up droplets of the disease and possibly touch your eye or nose. We're still trying to understand how much transmission occurs due to one or the other, do you need to have both, we don't really know how long you need to be exposed, but there are multiple researchers working on this, including myself. You know it is something that washing your hands can help you with, and obviously being very careful, people covering their mouths, and all that kind of good sort of etiquette helps prevent the spread of flu.

So the trials that I mentioned, these challenge trials, our participants are not prisoners here, they are free to request to leave the unit. We typically tell them upfront that we would like them not to do that once they have been given a virus, because they are potentially contagious and it could be dangerous to other individuals outside of the hospital, so they've signed a consent form before coming into the unit and have been given ample opportunity to make a decision as to whether they are going to be able to stay here. Up until this point we have never actually had anyone try to leave the unit early from the influenza trials, and we've given influenza to nearly 400 individuals. All of our participants have made it through the trial, but if it was necessary that somebody decided to leave, we do have a system in place of precautions that we would take in order to make sure that it was as safe as possible for the person to go home.

So clinical trials--it takes a lot of work to organize and you have to have a large team generally to do that. Our trials, we have a team of nurses, physicians, as well as other non clinical staff, all of which who participate, it is really a team effort, all the way from the beginnings of the design of the study, through all of the approvals that we have to go through in terms of safety, ethics, and other types of scientific reviews. Many of our trials involve investigational products and so they're reviewed by the Federal Drug Administration (FDA) and, you know, it can take many many months, sometimes even a year or more, before these studies can start, and then once they start it's an enormous team effort to get them completed so it's really a lot of work but many times these trials can be very worthwhile, because studying disease in humans really is the pinnacle of doing research, I think, for medical disease in humans.

So developing a new and better influenza vaccine is extraordinarily challenging because the influenza virus is very good at changing. It's very good at adapting and surviving and the virus is constantly changing from year to year, and we also have the threat of new viruses appearing, moving from animals to human, or even human viruses just changing in a way that could cause large amounts of infection. It's been very difficult to find a way to develop a vaccine that could protect us against all of those viruses, and on top of that, you know, we talk a lot about a universal vaccine, meaning it's universal in terms of the viruses that we can protect you against, but we also have a wide diversity in the types of people we need to protect, whether they be elderly people, young children, people with different types of diseases, and so trying to find a vaccine, or multiple vaccines, that could protect that wide diversity of individuals, and protect against all of the different influenza viruses that we want to protect against, is really an extraordinary challenge that many of us in the flu community are working very hard towards, and I hope that we will continue to make progress in this area.

So the flu shot right now that we have is a good vaccine that does offer protection. The protection can vary year to year depending on multiple factors. Some of those factors are how well the scientists who design the vaccine determine what the likely flu strains are that are going to circulate, some factors go into how the vaccines are manufactured year to year, sometimes that changes depending on the vaccine manufacturer, but in every year the vaccine does offer some level of protection. And so by getting the vaccine, you're giving yourself a chance of having some protection and whether that means it's going to protect you completely from the flu, or just make you less likely to spread the flu to your friends or family, or just make it so that the flu that you get is a little less severe than it would have been if you didn't get it, it's probably offering you some level of protection. And so I think right now it's not a perfect vaccine, but it does give you some protection and it's definitely worth getting, and so if you haven't gotten your flu shot, go ahead and do so, and hopefully it will help you get through this next flu season.

Sure, so please, you know, if you're interested in any of our healthy volunteer trials go ahead and call that healthy volunteer number, it's 1-800-411-1222. If you're interested in the flu trials, go ahead and ask for the influenza challenge trials, if you're interested in the respiratory syncytial virus or RSV trial, that's also going to be going on again in a few months, go ahead and call that number and ask for RSV. You can also just call and say, you know, I'm a healthy person, I'd be interested in doing things, you know, what are my options? And they'll let you know what's going on. So please go ahead and call that number.

Thanks.