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January 27, 2015
Contact: HHS Press Office

Transcript for HHS Telebriefing: Update on Ebola Clinical Trial Research

Press Briefing Transcript
Thursday, January 22, 2015

Audio recording [MP3, 11 MB]

Please note:  This transcript is not edited and may contain errors.

OPERATOR: Good afternoon and thank you for holding. The lines have been placed on a listen only mode. If at any time you would like to ask a question please press star 1.  I would like to remind all parties the call is being recorded. If you have questions please disconnect at this time. 

BILL HALL: Thank you for joining us today on the clinical efforts underway on Ebola vaccines and therapeutics. Since the West Africa Ebola outbreak many agencies in HHS have been working with unprecedented speed to develop and test potential vaccine and therapeutic candidates.  Given that there is a number of efforts that are moving along we felt this would be a good point in time to update you all on the status of this collective work and to offer you all an educational opportunity to get your questions answered by all of our experts on the phone with us today. Joining us are Dr. Anthony Fauci, the director of the National Institute of Allergy And Infectious Diseases at NIH.  Dr. Anne Schuchat, the director of the National Center for Immunizations and Respiratory Diseases, Dr. Robin Robinson, the director of Biomedical Advanced Research and Development Authority in ASPR here at HHS and Dr. Luciana Borio, the director of the office of Counterterrorism and Emerging Threats at FDA.  So we will hear brief opening remarks from each of our speakers and then we will open it up to your questions. So with that let me turn it over to Dr. Fauci to begin. 

ANTHONY FAUCI: Thank you. Good afternoon ladies and gentlemen.  The National Institutes of Health and our research partners continue to pursue the development of vaccines and treatments that could still be of use in the current outbreak, particularly in the event of rebound as well as future outbreaks, which historically have shown to be inevitable. Let me first summarize briefly where we stand with vaccines, and then with treatments, and then I will conclude with a few final thoughts concerning trials planned to be conducted in Liberia. A safe and effective Ebola vaccine will undoubtedly be a critically important tool to help prevent Ebola virus infections in future outbreaks.  Depending on the trajectory of the current epidemic, it could contribute significantly to its containment. Our hope is that such a vaccine could be licensed and used in the field to protect front line health care workers as well as people living in areas where Ebola viruses exist and so NIAD and GlaxoSmithKline-GSK- have developed an experimental vaccine that use Chimp Adeno   virus type 3 (cAd3) as a vector to introduce selected, non-infectious Ebola virus genes into the body.  Once injected into the body these genes encode Ebola proteins, not virus, but proteins that stimulate an immune response against the Ebola virus itself. The NIAID/GSK vaccine candidate has shown promise both vaccination in animal studies and phases 1 studies in humans, which are designed to determine if the product is safe and if it generates a potentially protective immune response in healthy volunteers.

Additionally, NIH has collaborated with the United States Department of Defense and NewLink Genetics Corporation on phase 1 studies of another vaccine candidate, which uses the Vesicular Stomatitis virus, or VSV as a vector or carrier for the Ebola genetic material that I mentioned with the other vaccine. This vaccine candidate was developed by and licensed from the public health agency of Canada and supported by the D.O.D.  NewLink has partnered with Merck Corporation on its further development.  Similar to the NIAID/GSK candidate, the New Link/Merck vaccine has looked promising both in animals and phase 1 human trials.

The next step is to determine the efficacy of both of these vaccine candidates, in addition to further proof of safety.  In this regard, under the auspices of a formal partnership between the United States government, the government of Liberia is now planning to conduct a larger, phase 2/3 clinical trial of these 2 vaccines in Liberia starting within the next couple of weeks with final approval pending, after we work out some  details, from the FDA. The plan is to conduct a randomized, double-blind controlled trial, which is considered the “gold standard” design to determine if an intervention is safe and effective.  Volunteers will be drawn primarily-but not exclusively from- populations at highest risk for exposure to Ebola, such as health care workers, household contacts, contact tracers and members of burial teams. After giving informed consent, participants will be assigned at random to receive the NIAID/GSK candidate, the New Link/Merck candidate or a placebo injection.

Now, I would like to say a few words about where we are with the development of potential therapeutics for Ebola.  Supportive care, including careful attention to fluid and electrolyte replacement, is currently the most effective medical intervention for patients with Ebola virus disease. No drugs are currently available that have been shown to be effective and safe that specifically treat Ebola virus infection. Drugs licensed or approved for the treatment of other diseases also are being re-evaluated for the potential treatment of patients with Ebola on an emergency basis. In parallel, NIAID is supporting the development of novel therapeutics targeting Ebola virus. In this regard NIAID has provided clinical services to obtain pivotal safety data in support of MAPP Biopharmaceutical’s Therapeutic known as Z-MAPP As has been widely reported it ZMapp has been administered to several Ebola- infected patients. However, because the drug was not administered in the context of a clinical trial, it is not possible to determine whether it actually ZMAPP actually benefitted those patients.  Under the auspices of the formal partnership that I mentioned earlier we are developing plans together with the government of Liberia to evaluate ZMapp through a study in the United States and Liberia.  Depending upon the outcome of this first phase of the trial other treatments may be tested in additional subgroups of patient volunteers.

I want to conclude with just a few thoughts about the upcoming clinical trials in Liberia. It is important to balance the urgency to deploy investigational medial counter measures in an emergency with the need to evaluate these counter measures through rigorously designed clinical trials. The trials to be conducted in Liberia are being designed with strict attention to safety considerations, established scientific principles, and ethical considerations including compassion for the immediate needs of the affected populations.  Importantly, community engagement is a critical component of trial preparations as community leaders, including traditional chiefs and elders, have played a pivotal role in successfully combatting the Ebola outbreak in their country.  Before they begin, both studies will require multiple reviews and approvals in the United States as well as in Liberia. Data will be regularly reviewed by independent monitoring boards as the trials are ongoing to look for any safety concerns or early signs of efficacy.  Let me stop here and I will be happy to take questions after my colleagues have given their prepared remarks.  Thank you. 

BILL HALL:  Thank you Dr. Fauci. Next we will hear Dr. Anne Schuchat from CDC. 

ANNE SCHUCHAT: Thank you, Bill.  Thanks everyone for joining the call.  This has been an unprecedented outbreak of Ebola virus disease but it is also an unprecedented opportunity to accelerate development in the evaluation of vaccine against this terrible disease. In Sierra Leone, CDC is supporting partners specifically the College of Medicine and Allied Health Sciences and the Ministry of Health and Sanitation to set up a clinical trial that will look at one of the candidate Ebola vaccines. As you can imagine preparing for a trial requires a substantial amount of planning and coordination. It is even more complicated to do this in the midst of a difficult epidemic like this one. Study team and partners have been working intensively under a compressed timeline to be able to launch the trial in order to evaluate and eventually gain access for vaccines for high risk people. While maintaining safety, ethics and scientific standards. The design of the trial that we are planning for Sierra Leone is a phased introduction study that will target health care workers and other high risk front line workers in select districts, to be vaccinated in a rolling way comparing disease risk and those vaccinated early with those who are vaccinated later. Which vaccine will be used hasn't been finalized, but we are working closely with colleagues to review the emergence safety data response and practical and logistical considerations for the country as well as working closely with manufacturers on understanding available doses. I want to emphasize that because we don't know how much protection the candidate vaccine will offer we will continue to stress with participants the importance of good infection control, including use of personal protective equipment, and reinforce key messages that have been part of this response. We have had a team in country since November working very closely with our partners. We have a team here in Atlanta, as well. We are working very hard to make as much progress as we can to launch this trial as soon as possible.  In country the team is identifying health care workers who will be eligible for the study, finalizing vaccination sites to prepare for quality type vaccination. We are working and making sure there is engagement with key partners and stakeholders. We are working out all the standard procedures that need to be implemented for the trial to begin. There are still many steps that need to be taken before the trial can be launched including finalizing the protocols and assuring the appropriate final ethical reviews, and working with the companies for the dose preparation to get them in country, as well as the training of staff and preparation of the final materials. But I want to close by acknowledging some key partners, the Ministry of Health and College of Medicine and Allied Sciences and CDC staff and partners, in our preparation for this trial. Everyone involved is working very hard to address the challenges and planning to implement this study in the middle of an outbreak. I have to say personally that the country's leadership has been really incredible to work with. When I was Sierra Leone earlier I could see how devastating the virus had been to the health care system and the health care professionals I met had lost friends and colleagues to this terrible virus. An Ebola prevention vaccine trial offered a new kind of hope in this type of context. For us it offers a chance to strengthen the country's long-term ability to carry out important research on national priorities. Since we can't predict what direction the epidemic will take or when the next one will occur our study team will continue working to get the vaccine study launched as quickly as we can and continue to work closely with partners. By working together to improve proven prevention methods such as practicing infection control, seeking early treatment and practicing safe burials, we have been seeing progress. But we also hope the trial will contribute towards finding a safe and effective vaccine that can provide an additional prevention strategy to save lives during this outbreak or future ones. So I would like to turn things over to the moderator. 

BILL HALL:  Thank you Dr. Schuchat and next we will hear from Dr. Robin Robinson from BARDA here in ASPR. 

ROBIN ROBINSON:  Thank you Bill. Thanks to my colleagues and thank you for your interest out there. BARDA, the Biomedical Advanced Research and Development Authority, has been involved in the Ebola response since last August. We applied principles that we use every day for other threats, influenza and other emerging diseases. We address the consequences of both man made threats and emerging infectious disease. We work with federal partners at CDC, NIH, FDA, and DOD to transition medical countermeasures from early development that NIH and DOD do so well into advanced development towards ultimate FDA approval. We utilize in concert with federal partners with private partnerships with industry to ensure that we have the medical countermeasures to protect our citizens here in the U.S. and those in other countries like in West Africa with Ebola.  And we have used our medical countermeasure infrastructure that we have established to actually help with this Ebola epidemic. We are supporting the large scale production of the medical countermeasures for the Ebola response for this and other emergencies. We have been working on both therapeutic candidates and vaccines. I will take therapeutics first. BARDA has been working on antibodies for Ebola and taking strategy in three elements. First, we utilize what was existing with the tobacco-based pharmaceutical company to produce ZMapp, which is a cocktail of three different antibodies that protect cells from being infected with the Ebola virus. Knowing that that was only one manufacturer, we expanded efforts to other tobacco-based bio- pharmaceutical companies to produce the same product.  Lastly, we went to other biopharmaceutical companies that use different types of expression systems and are working with them to develop new antibodies and a version of the ZMapp that is produced in those cells.  Let me take the first one as the production and development from a company working with Kentucky bio and we started last September.  Production at the Kentucky bio processing facility started last August. We have six different campaigns that will be going on through early next June.  And at this point we have actually finished with three of the six campaigns and two of those have been filled into vials. These are clinical investigation lots and will be used for the clinical trial studies that we spoke of earlier.  In addition we have technical experience in producing antibodies and other biologicals.  We worked with Kentucky bioprocessing and have seen an increase in the production yield already.  Subsequently we project that in the near future the phase one and two clinical studies here in the U.S. and Liberia will start with these clinical materials.  We continue to work with the FDA to make sure that we have a good proposal that can go in and can be improved rapidly and move those clinical studies forward. Turning to other tobacco producers we began a search for other pharmaceutical companies that use tobacco plants all over the world.  We focused primarily on three or four here in the United States that can utilize the technology and have been able to work to make a ZMapp-like product. We are working with our colleagues over at DOD to utilize contracting mechanisms to engage these companies to start making these products and they will be tested for comparability as we go forward in this winter. Lastly the development of a product we have reached out to a number of pharmaceutical companies and have been working since last September with Regeneron and Genentech to develop a ZMapp-like product. These companies produce a number of commercial antibody products for cancer, rheumatoid arthritis and other diseases.  They have quickly made huge amount of progress with these new antibodies and are being tested very soon.  If they are successful in protecting these animals challenged with Ebola virus they will move into clinical studies to show comparability.  And in our effort to be able to produce products at large scale we will utilize these as another product candidate in large production using our centers for innovation in addition to the two companies I spoke of earlier. 

Let me turn to vaccines. Transitioning Ebola vaccine candidates from early development into advanced development. Currently we are supporting the advanced development manufacturing and testing of three of the Ebola vaccine candidates.  We are in discussion with Johnson & Johnson for the fourth one. The work we’re supporting will ensure that the manufacturing processes are capable of commercial-scale production to produce millions of vaccine doses. And we’re providing both technical and clinical experts on the ground to assist in those clinical trials. Lastly, we’ve been moving forward with our manufacturing network as part of the national infrastructure to fill the vaccines for the clinical trials that are ongoing and are planned for later on. In conclusion we feel our partners have made significant progress in the Ebola crisis and over the past decade for all types of emergencies. We feel pretty honored that we can provide our experience and expertise in medical counter measures for this event and will be happy to take questions later.  Thank you. 

BILL HALL:  Thank you Dr. Robinson, Our final speaker today is Dr. Luciana Borio from FDA.

LUCIANA BORIO:  Good afternoon and thank you for the opportunity to speak today about the FDA’s response to the Ebola epidemic. As previously stated the epidemic is a serious global health security crisis and we are taking extraordinary steps to be proactive and flexible in our response.  We are working with our federal colleagues and interested international organizations to facilitate the development and to evaluate safety and efficacy of treatments and vaccines as quickly as possible. Sadly, this will not be the last Ebola outbreak and our efforts matter for generations to come. Although there are investigational products in the early stages of development there are currently no vaccines or drugs that have been shown to be safe and effective in preventing and treating Ebola. To this end we are in constant communication with our HHS colleagues and multiple medical product developers to clarify regulatory requirements, provide input into pre-clinical training and clinical trial design, address manufacturing issues and give advice to accelerate further development.  We are also expediting review data as they are received from developers. And as a result investigational products for Ebola are moving forward at an unprecedented pace.  We are supporting the conduct of well-designed, efficient, reliable and ethical clinical trials to determine the safety and effectiveness of potential Ebola therapeutics and vaccines. For example, our scientists worked with NIH to develop a simple and innovative common protocol to test investigational drugs that can be conducted in affected countries and in the U.S. Properly designed trials are essential to determine whether these investigational products help, harm, or have no impact on patients. To augment diagnostic capacity, we have contacted several commercial developers and have encouraged them to work with us to quickly develop their tests. We have already authorized the use of several diagnostic tests for Ebola. To harmonize and accelerate development FDA is in regular communication with our international regulatory counterparts, including the European Medicines Agency and Health Canada. We are fully committed to sustain our deep engagement and aggressive response to this epidemic. We appreciate the gravity of the situation and are exercising maximum flexibility in our activities. We will continue to work closely with our U.S. government colleagues, international partners and product developers to speed up development and availability of promising medical products.  Thank you. 

BILL HALL:  Thank you Dr. Borio.  Elon, I think now we can open it up to questions. 

OPERATOR:  Thank you.  At this time if you would like to ask a question please press star 1 on your touch tone phone.  You will be prompted to record your name. Our first question today is from Maggie Fox from NBC News. 

MAGGIE FOX:  Thanks so much.  I had several questions but more importantly I could barely understand some of the facts that were being given out on what were some muffled phone lines.  I know people were doing their best.  Can we please have a written fact sheet especially about some of the public/private partnerships that Dr. Robinson was talking about?  Second, can you talk about which trial will start first and where?  And who exactly will be part of the trial?  There is going to be a vaccine trial starting first, is that right? 

ANTHONY FAUCI:  Maggie, this is Tony.  It is likely, again, as I mentioned there are final details that are being worked out with the FDA on the trial that I described of the randomized control trial using the two products.  It is likely that that will start earlier than the trial that Anne mentioned because of the reasons that she clearly articulated. I don't think much sooner but I think if you are going to predict that it is likely that the trial in Liberia using the RCT design will likely start first. 

MAGGIE FOX:  And when do you anticipate the therapeutic trial starting? 

ANTHONY FAUCI:  That probably would start a couple of weeks after that.  I would think within the next three weeks I would say.  The way we are working it right now given the availability of the product and all of the things that we need to go through we are about two to three weeks after approval by the FDA.  We expect that reasonably soon. 

MAGGIE FOX:  Thank you. 

BILL HALL:  Thank you.  Elon, next question. 

OPERATOR:  Next question is from Liz Szabo from USA Today. 

LIZ SZABO:  I am wondering how the declining number of cases in West Africa which is a good thing will affect your ability to conduct these trials.  Will you have to have bigger trials or longer trials? 

ANTHONY FAUCI: There are two separate trials.  I will comment and then Anne can comment about the trial that she described.  It certainly won't impact the conduct of the trial for the following reasons.  The trial design has been put together very carefully, statistical analysis numbers, etcetera.  There are three possible scenarios given the current diminution in cases in Liberia for the trial that I described.  First, even though the numbers are very low there is always the possibility of little mini outbreaks.  So one thing you learn and that has been articulated many times by several of us is that unless you extinguish the last case, it’s not over until it is over.  The other thing is that there is a possibility depending upon what is going on about doing some partnering but that would obviously need to be worked out between the CDC, NIH and Liberia.  We have had some discussions with officials but that is too preliminary to make any definitive statements.  Finally and probably the most important is that we are trying to prove the efficacy of a vaccine in a trial in which infections are occurring.  This would be a good thing for all if the infections disappeared in a few weeks.  The data that you get on safety and a subgroup of patients could be very important for what we call alternative regulatory approval.  You can carry out the trial, not prove efficacy but get enough safety data to allow for an alternative approval such as by the animal rule. 

LIZ SZABO: Thanks.

ANNE SCHUCHAT: Maybe I could share a little bit from the perspective of the trial being planned for Sierra Leone.   We have modified some of the aspects of our design to increase its flexibility and to increase the chance that we will be able to measure the efficacy given the likelihood for fewer -- for lower rates of disease. This has involved switching from a fixed size of enrollment to an event-driven design where we will be able to have rolling enrollment and expand or extend the duration.  So much of the design remains but rather than having the number a fixed, we will have an event drive design. And rather than a fixed amount of vaccination we have ability to expand to more people. This also addresses the reality that we won't be able to start as early as we would have liked to. So rather than people being vaccinated pretty much systematically throughout the trial period we will be trying to front load a lot of vaccinations and also have more people vaccinated towards the end of the trial.  Again, people will be randomized for the time of immunization, not to either a vaccine group or a control group. We will try to get more people vaccinated earlier than with the previous draft design. That said, we are working closely across the partnerships and making sure that we take advantage of these candidates being ready to go and also don't cut corners. We, like the NIH, have set up a data monitoring board that is reviewing closely both design and progress. 

BILL HALL:  Thank you.  Next question please. 

OPERATOR: Our next question is from Richard Harris from NPR. 

RICHARD HARRIS: Thanks for giving us this update. I have a couple of quick questions for Dr. Robinson.  First, how many ZMapp doses have been produced to date? And could you explain why they are producing it in tobacco instead of the Chinese hamster ovaries (CHO) itself. It seems to be a much faster production system. My third question is if you could clarify BARDA’s role in vaccine production because manufacturers have been saying that they themselves have been manufacturing the vaccine. I'm trying to understand if you are helping them or also producing it in addition to what the manufacturers have reported? 

ROBIN ROBINSON: All good questions. Thank you. The amount of ZMapp we have produced so far is again from three campaigns. It should be sufficient to actually get us through the phase one and two clinical trials and we will continue to make more as we go forward. Our efforts with the tobacco-based manufacturers and also with the CHO cell-derived product, allows it to go to commercial scale and produce maybe thousands of treatment courses. But again that is a little bit further down the road. The second question, why is ZMapp in tobacco plants and why aren’t we using CHO cells? That’s a very good question. The reason for it is that they actually tried to produce it in CHO cells and the primates’ study showed that the product was only partially protective. When you put it in tobacco plants, that tobacco plant is actually missing certain sugars that would go on the protein and that actually enables the antibody to bind better to the virus and to neutralize it. As it turns out, it is a better product if the CHO cell is derived in the normal way that you use CHO cells. This is why we are working with companies now using a specialized CHO cells that do not have those sugars and that’s why we have some hope that they will work in the studies and ultimately be an alternative product.

And then relative to the vaccine production-- as we have done with influenza vaccine, smallpox and anthrax vaccines, we are supporting the development and manufacturing. One of the things we are doing is making sure that they can move from pilot scale to commercial scale and are able to do the correct number of studies and optimize and validate that manufacturing process. Secondly, we are making sure that the analytical assets used to make these vaccines available are optimized and they have been validated so that would actually help later on with licensure. Lastly we are working to formulate the product, which is now stored at ultralow minus 70 degrees. If we can actually make the products so they can be stored in refrigerator or even better yet, room temperature, that would be easier to transport and utilize and administer in West Africa and anywhere else in fact. Those are three main things that we are doing. We are also supporting some clinical studies. 

RICHARD HARRIS: In terms of the number of doses that you need for the phase one and two for ZMapp, what number of doses do you have there? 

ROBIN ROBINSON: Those are going to be anywhere from probably 50 to 150 treatment courses. Remember with ZMapp, there are three doses per treatment course. 


BILL HALL: Next question please. 

OPERATOR: Thank you. Our next question is from Lauran Neergaard from the Associated Press. 

LAURAN NEERGAARD: Hi, just a quick question. If you can go over the number of participants that you anticipate having in both the Liberian trials and the Sierra Leone trials. 

ANTHONY FAUCI: This is Tony. The Liberian trial it is going to be 27,000 people. 

ANNE SCHUCHAT: And Sierra Leone, as I mentioned we have moved from a fixed number to an event-driven another, but we are estimating to begin with about 6,000 initially. It may need to expand beyond that. Ours is primarily targeting the health care workers, whose risk is a bit higher than general population. 

LAURAN NEERGAARD: Great and if I can just follow up with the Liberian trial, how long do you anticipate that will take with the high level of enrollment? 

ANTHONY FAUCI: That is going to depend a bit on the infection, if there’s outbreaks it would make it easier, but I would say anywhere from three quarters of a year to a full year. 


BILL HALL: Next question please. 

OPERATOR: Our next question is from Andy Pollack from New York Times.

ANDY POLLACK: Dr. Robinson, when do you anticipate having efficacy results from the ZMapp trial? And can you give us an idea of how many doses you think could be available to actually use commercially assuming the trial works? How many doses, how quickly and how much of those doses do you anticipate will come from the CHO cells and how much from the various tobacco initiatives you have? 

ROBIN ROBINSON: So I will probably ask Dr. Fauci to help me a little bit with the efficacy trial since the NIH is performing that in Liberia. Certainly that will be many months going forward and again the numbers will be about 50 to probably 100 or 150 people who will need to be treated to actually come up with the data there. And relative to the amount, once we know that there has been efficacy shown, the tobacco manufacturers will probably move ahead by the end of the calendar year with that technology from CHO cells. If that works and we are still a long way from that point right now because we have to show that it actually works in primate studies before we move into human clinical studies, the manufacturing would be able to produce thousands of treatment courses by the end of the year. 

ANTHONY FAUCI: Let me give you more about the numbers. When you want to show efficacy for a drug in a sick person it will depend-- since you have a control group which I mentioned is getting enhanced standard care with fluid and electrolytes and treatment compared to the same thing for ZMapp-- it really depends very much on the death rate in the control group versus how many people don't die in the ZMapp group. If the ZMapp turns out to be 100 percent effective, the lowest number that you can get and you could probably get your answer with 12 people possibly. If the efficacy is 40 or 50 percent or so, it is likely closer to needing 40 people. So it really depends on what happens in the controls and how effective it ultimately is. 

BILL HALL: Thank you. Next question please. 

OPERATOR: Thank you. Our next question is from Helen Branswell from the Canadian Press. 

HELEN BRANSWELL: Thanks very much for taking my questions. I have a couple if I could please. One for Dr. Schuchat, could you please indicate when CDC thinks it will be able to decide which vaccine it will test? The second, for probably Dr. Fauci, I know you said it is early to talk about this, but clearly you are thinking about adding Sierra Leone to the big Liberian trial that you have been working on. Can you explain what you are referring to there? Because Liberia’s new case rate is so low now it's really hard to see how you are going to be able to find an answer there. 

ANTHONY FAUCI: Well, again, answer of efficacy we recently met here at the NIH with some health officials from Sierra Leone and Liberia and in the room, in my conference room we discussed this. They met with other people from HHS. There was a desire expressed for possible collaboration between the two countries health systems in a RCT, not to replace at all anything that is happening there, but it will depend on the countries themselves agreeing to this. But they proactively brought up the possibility of there being some collaboration between Sierra Leone and Liberia and we are very careful not to overstep our bounds. I mentioned that only because they brought it up. If in fact they pursue that that is a possibility that there could be some collaboration between the countries which would involve our trial. 

ANNE SCHUCHAT: So the question about the Sierra Leone trial and when a choice will be made. There is additional phase one data that we are expecting to review within a week or so. That is a critical piece of data that we are awaiting. We hope that within the next two weeks we will be able to finalize the vaccine choice. But of course it is depending on the data being shared with us. The leadership in Sierra Leone has also been reviewing the data as it comes in. We have had good discussions with them as a critical piece of how the choice will be made. 

HELEN BRANSWELL: May I ask a follow up question please? Have you or has someone set a dose for either of these vaccines or both of these vaccines at this point? 

ANTHONY FAUCI: The answer is yeah. The companies are the ones that set the dose and the dose the anticipated doses that we're talking about for the Glaxo-NIH one is one times ten to the eleventh. The one for the VSV will likely, though it has some final things to be looked at, likely be in the order of two times ten to the seventh for the VSV. 


BILL HALL: Next question please. 

OPERATOR: Next question is from Steve Baragona from Voice of America. 

STEVE BARAGONA: Hi, thanks for doing the call.  I was wondering if you are going to do a trial in Sierra Leone in addition to Liberia, are you going to do the same vaccine? What would be the advantage of doing another trial?  And why would there be two different study designs for two trials? 

ANTHONY FAUCI: First of all, we don't want to get ahead of ourselves about two different study designs. First of all, the vaccines that we are talking about are the same vaccines. So there are two vaccines on the table. There is the VSV and there is the Glaxo-NIH one. The Liberia RCT trial is going to test both of them against placebo. And Dr. Schuchat just mentioned that she will decide with her colleagues which of those two that she will use in the trial that she described. So we are not talking about different vaccines. We are talking about the same vaccine pool. Now, when I mentioned the Sierra Leone possibility again anything that would be done would be done in close collaboration with the lead agency which is the CDC in Sierra Leone, if in fact it at all comes to pass that anything is done with that design in Sierra Leone.  But don't think that these are different vaccines that are being tested. It's all the same pair of vaccines. 

STEVE BARAGONA: And what is the advantage of having two different trials going on simultaneously? 

ANTHONY FAUCI: You know, there are certain advantages. There is no doubt that everyone agrees that the randomized control trial which is a larger trial is the way you can get a definitive efficacy signal. The other designs might be logistically easier to implement and might even be more acceptable in one society versus another but the probability of getting a definitive FDA acceptable efficacy standpoint is considerably less for those other designs compared to the classical randomized control trial. And that's the reason for essentially covering different bases. 

STEVE BARAGONA: So you get more people and might not get as good an answer. 

ANTHONY FAUCI: There is no doubt that the randomized control -- rather than just my saying that, why don't I ask Lou Borio to comment about that because this is something that certainly involved what the FDA will accept as acceptable data. 

LUCIANA BORIO: Sure. Thank you. So you know the randomized control trials are more efficient and usually are a lot more likely to yield very interpretable definitive data. One other advantage of the randomized control trial that Dr. Fauci has explained is that we will be able to test the two leading vaccine candidates in the same trial and that is very important. So do you have any more questions about that? 

STEVE BARAGONA: Then I’m wondering what the purpose of the Sierra Leone trial would be? 

LUCIANA BORIO: I’ll defer that to CDC to explain the rationale for doing a second trial.  There are some advantages as Dr. Fauci mentioned, but Dr. Schuchat might want to add to that.

ANNE SCHUCHAT: Thank you for the chance to speak about this. Across the U.S. government we have been closely collaborating for months now on the best ways to control the epidemic, but also the optimal ways to accelerate vaccine evaluations and eventual use. Early on we discussed the idea that a multipronged strategy might actually be an insurance policy or hedge our bets about some things not working out in one place or another. By the way, there is a non U.S. government consortium working with people in Guinea to try to develop a trial for that country, as well. We have seen over the past years many surprises with Ebola virus disease with this epidemic being of unprecedented scope and magnitude. So months ago we moved forward with intensive planning with both Liberia and Sierra Leone on designs that would address the scientific, ethical and safety issues as well as the practical and logistic issues. I think everybody has been racing to get the trial launched as quickly as we could and as carefully as we could recognizing the complex context because the populations of these countries have just been through unconscionable trauma. I would say that going forward we will continue to work well and closely across the department and with our partners in countries, and hope that multiple trials will be successful. Thank you.

LUCIANA BORIO: I would just like to add, this is Lu Borio again, to add one more thing. As Dr. Fauci mentioned earlier in his remarks, that it is important to collect immunogenicity data for the trials because if one cannot meet a clinical end point given the changing epidemiology of the disease we will pursue, we will examine the possibility of looking at data and consider alternative regulatory approval mechanisms, such as accelerated approval which is based on immunogenicity. So, in that regard, the randomized control trial is particularly well suited to be able to give us this important immunogenicity data that may become very important in the setting up of declining disease incidence rates. 

STEVE BARAGONA: Thanks very much. 

BILL HALL: Next question please. 

OPERATOR: Our next question is from Maki Kitamura from Bloomberg News. 

MAKI KITAMURA: Hello. Thank you for taking my questions. I wanted to follow up on the alternative regulatory pathway. I think this is answered in the previous question but just to be clear you are gathering this immunogenicity data from the phase three trial, not the phase two trial in the surrounding countries? How long do you think it will take to gather that data and how soon could you file through this alternative pathway? 

ANTHONY FAUCI: I wouldn't make is distinction between phase two and phase three. The data that is being collected, that will be collected by both trials are data that can be used certainly for safety. We will have a limb of it or a subset of people who would be vaccinating that would actually do the immunogenicity studies. If there had been no outbreak at all, if this were just the normal pathway with no outbreak the natural approach that would have been taken by the companies involved would be to collect enough safety and immunogenicity data together with the efficacy data which is quite impressive in the animal model and use that as their filing for a licensure under what Dr. Borio has described as an alternative regulatory mechanism. 

MAKI KITAMURA: And how soon would that be -- how soon do you think you could file that data? 

ANTHONY FAUCI: It wouldn't be a good idea for me to be talking about how long it is. It depends on how many people you get. The data needs -- it really is an issue where the companies will work out with the FDA what the FDA would need to be able to pursue that alternative pathway. 

MAKI KITAMURA: Thank you. 

BILL HALL: Next question please. 

OPERATOR: Our next question is from Monte Morin from LA Times.

MONTE MORIN: In the last few days there have been reports about conservationists and primatologists talking about Ebola outbreaks in the past wiping out enormous numbers of gorillas and they’re wishing there was a vaccine available for them. I was hoping you could provide some perspective. Is that a possibility that can be entertained at this point? 

ANTHONY FAUCI: That's a possibility, but that is not really right now on our radar screen. We would certainly have to consult with people with expertise in the conservation movement. Particularly the people in country, the Liberians and the Sierra Leoneans and others in those areas in which there is destruction of populations of non-human primates. I don't think it would be appropriate to make any statement about that. I certainly would think it could be a possibility. That is not our area of expertise. 

BILL HALL: We have time for one more question. 

OPERATOR: Our final question today is from Brady Dennis from Washington Post. 

BRADY DENNIS: Thanks for the call. Dr. Fauci, I just wonder if you can elaborate briefly on you talked about this a little bit, how soon do you expect that the trials could begin in Liberia?  I didn't know if you had information both on is this going to be in certain parts of the country?  As far as geographically where is the focus going to be? When it comes to vaccines itself how many initial doses? Are those already in country? Who is bringing those?  I don't know if they are stored and waiting to be used or where that stands? 

ANTHONY FAUCI: So there’s a lot of questions there. Let me try and see if I can remember them all. It’s going to be focused in Montserrado County in Monrovia and will be the major place. That is the first thing. The doses are on their way to being sent to the sites in which they will take place. I mentioned carefully that this would likely begin over the next couple of weeks. And the reason I said couple of weeks is because we were expecting that we would start probably on the last week in January, but there are some details that need to be ironed out regarding the FDA. You go back and forth about the extra things, non-show stoppers, nothing that is an issue, but things that we need to attend to in the protocol. We should be able to iron that out in the next couple of weeks. Although we expected it to start at the end of January, it may get pushed back by a week or so but not much more than that. 

BRADY DENNIS: And the only other piece of that was you said you hope to initially involve about 27,000 people. How big a group does it start out with? 

ANTHONY FAUCI: Well, you don't do them all at one time. For example, the first phase in group, the run in group will be about 600. And from there will go on. 

BRADY DENNIS: Thank you. 

BILL HALL: Thank you all for joining us today. A special thank you to our speakers who joined us today. Now this concludes our call. Thank you very much. 

**This transcript is not edited and may contain errors**

Note: All HHS press releases, fact sheets and other news materials are available at https://www.hhs.gov/news.
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Last revised: January 27, 2015

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