Texas Biomedical – Frontier of biomedical research and development for Ebola virus in Sudan

Sudan Ebola vaccine and antibody treatments tested at the Texas Biomedical Research Institute have been sent to Uganda as part of
efforts to control the outbreak there.

The Sudan Ebola virus is one of six known Ebola viruses, with a fatality rate of between
41% and 100%.
However, previously there was only an effective vaccine against the Zaire variety, and it is the Sudanese species
that currently affects Uganda.
This has led to at least 142 infections and 55 deaths, including many children
, since the outbreak of the virus in Sudan in September.
Now, the World Health Organization and other global entities announced in November that they are working with Ugandan officials to distribute Sudan's Ebola vaccine candidate for clinical trials
.
One of the vaccine candidates, currently being developed by the Sabin Vaccine Institute, is currently undergoing preclinical testing at the Texas Biomedical Research Institute to evaluate safety and efficacy, and the first vaccines are now shipped to Uganda
.
The institute has also been awarded a subcontract from Mapp Biopharmaceuticals to support the development of its antibody therapy, MBP134, which has been deployed to the region to treat infected patients
.
The development of vaccine and antibody candidates is currently funded
in whole or in part by the U.
S.
Department of Health and Human Services, the Strategic Preparedness and Response Administration, and the Biomedical Advanced Research and Development Agency*.

Texas Biomedical will continue to help develop vaccines and therapies
for Ebola in Sudan.
Notably, the institute has been awarded more than $35 million in subcontracts to conduct detailed FDA-required studies to determine whether Sudan's Ebola vaccine and therapy are effective
.

"These new multi-year contracts underscore Texas Biomed as a trusted and valuable partner across industry, government, and the nonprofit sector, all focused on solving some of the biggest health challenges we face as a global community," said
Dr.
Cory Hallam, vice president of business development and strategic alliances at Texas Biomed.

Texas Biomedical's contract research enterprise has tripled in the past three years, thanks in large part to its specialized expertise and facilities
.

"Only a few laboratories are able to conduct the regulated and specialized studies required by the FDA to support the approval of vaccines or treatments for these types of pathogens," explained
Dr.
Ricardo Carrion, head of the Texas Biomedical Company's Maximum Containment Contract Research Unit.

Work to study these deadly viruses must be conducted in the Biosafety Level 4 (BSL-4) laboratory, the highest and safest level
for researchers wearing full-body compression suits.
The Texas Biomedical Center is home to the first independently operated BSL-4 in the United States, which opened
in 1999.

The institute also houses the Southwest National Primate Research Center, one of
seven U.
S.
government-supported research centers.
For the past decade, Texas Biomedical has worked to build the animal models needed to study these viruses and conduct research to provide basic information for vaccines or therapies that may be reviewed
by the FDA.

"Our work in describing and modeling them helps pharmaceutical companies advance their vaccines and therapeutics faster because we've done the first part for them, providing baseline information about the virus in animal models," said Dr.
Kendra Alfson, a Texas biomedical staff scientist and first author
of the paper describing animal models of Ebola virus in Sudan.

Researching vaccines and therapies for this deadly pathogen is a challenge
for humans.
While people can be given a vaccine or treatment to confirm it is safe, determining effectiveness requires exposure to the virus
.
It is unethical to deliberately expose people, and the epidemic is sporadic and limited
in scale.
Therefore, in-depth research on non-human primates is the gold standard
for assessing the response of the entire body and immune system to a vaccine or therapy and determining the most effective dose.
In these cases, the FDA can use efficacy data from animals to approve new drugs and vaccines
.

In rare cases, such as previous Ebola outbreaks and the current Ebola virus outbreak in Sudan, if the vaccine has been rigorously tested for effectiveness in animals and initial safety testing in humans, it is possible to inject experimental vaccines into humans before formal approval and document the extent to which they have helped control transmission
.

Even if this happens, important details must still be gleaned from animal models, including specifying what biomarkers equate to protection against disease after vaccination, how long after vaccination acts as protection, and how long
protection lasts.

Dr.
Carrion explains, "Critical information like this can only be collected in a strictly controlled laboratory setting, not from human patients
.
We are proud to help contribute this knowledge to enable our partners to develop effective tools to protect people from these deadly viruses, especially as
outbreaks become more common.
”