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UrduSudan ebolavirus is one of six known species of Ebola, with a fatality rate ranging between 41% and 100%. While an Ebola vaccine now exists, it is effective against the Zaire species, not the closely related Sudan species currently affecting Uganda. Since the Sudan virus outbreak began in September, at least 142 people have been infected and 55 people have died, including many children.
The World Health Organization and other global entities announced in November they are working with Ugandan officials to distribute Sudan ebolavirus vaccine candidates in clinical trials. One of those candidates, currently being developed by Sabin Vaccine Institute, has been undergoing preclinical testing at Texas Biomed to evaluate safety and efficacy, and an initial shipment of the vaccine is now in Uganda. The Institute has also been subcontracted by Mapp Biopharmaceutical Inc. to support the development of its antibody therapeutic, MBP134, which has been deployed to the region to treat infected patients. Development of the vaccine and antibody candidates is currently being funded in whole or in part by the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA)*.
Texas Biomed will continue to help advance vaccines and therapies for Sudan ebolavirus. Notably, the Institute has been awarded more than $35 million in subcontracts to run detailed studies required by the FDA to determine if Sudan ebolavirus vaccines and therapies are effective.
“These new multi-year contracts underscore how Texas Biomed is a trusted and valued partner across industry, government and nonprofit sectors all focused on tackling some of the greatest health challenges we face as a global community,” says Cory Hallam, PhD, Texas Biomed’s Vice President for Business Development and Strategic Alliances.
Texas Biomed’s contract research enterprise has tripled in the last three years due in large part to its specialized expertise and facilities.
“There are only a few labs that can perform the regulated and specialized studies required by FDA to support approval of a vaccine or treatment for these types of pathogens,” explains Ricardo Carrion, Jr., PhD, who directs Texas Biomed’s Maximum Containment Contract Research unit.
Work on these deadly viruses must be carried out in a biosafety level 4 (BSL-4) laboratory, which is the highest, most secure level in which researchers wear full body, pressurized suits. Texas Biomed is home to the nation’s first independently operated BSL-4, which opened in 1999.
The Institute also hosts the Southwest National Primate Research Center, one of seven supported by the federal government in the U.S. Over the past decade, Texas Biomed has worked to establish the animal models required to study these viruses and conduct the studies that provide the foundational information for a vaccine or therapy that may go to FDA for review.
“Our work to characterize and establish relevant models helps the pharmaceutical companies move their vaccines and therapies forward faster, because we’ve done the first part for them, providing the baseline information about the virus in the animal models,” says Texas Biomed Staff Scientist Kendra Alfson, PhD, who is first author of the paper describing the Sudan ebolavirus animal model.
Studying vaccines and therapies for such deadly pathogens presents challenges in humans. While a vaccine or therapy can be given to people to confirm it is safe, determining effectiveness requires exposure to the virus. Deliberately exposing people would be unethical, and outbreaks are sporadic and limited in size. Therefore, in-depth studies in nonhuman primates are the gold standard to evaluate how a full body and immune system react to a vaccine or therapy and determine the most effective dosages. The FDA can approve new drugs and vaccines using efficacy data from animals in these cases.
In rare instances, like with previous Ebola outbreaks and the ongoing Sudan ebolavirus outbreak, if vaccines have already undergone rigorous efficacy testing in animals and initial safety testing in humans, it is possible to administer experimental vaccines to people before they have received formal approval, and document how well they help control the spread.
Even as this happens, vital details must still be collected from animal models, including specifically defining what biological markers equal protection against the disease after receiving the vaccine, how soon protection kicks in post vaccination, and how long protection lasts.
“Critical information like this can only be gathered in tightly controlled laboratory settings, not from human patients,” explains Dr. Carrion. “We are proud to help contribute this knowledge so our partners can develop effective tools that will protect people from these deadly viruses, especially as outbreaks become more common.”
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*BARDA contracts 75A50122C00061 and 75A50119C00055
About Texas Biomed
Texas Biomed is a nonprofit research institute dedicated to protecting the global community from infectious diseases. Through basic research, preclinical testing and innovative partnerships, we accelerate diagnostics, therapies and vaccines for the world’s deadliest pathogens. Our San Antonio campus hosts high containment laboratories and the Southwest National Primate Research Center. Our scientists collaborate with industry and researchers globally, and have helped deliver the first COVID-19 vaccine, the first Ebola treatment and first Hepatitis C therapy. For more information, go to TxBiomed.org.
