Marburg vaccine tested at Texas Biomed moves to Phase 2 clinical trials

2023-12-19
临床2期疫苗临床1期
SAN ANTONIO, Dec. 19, 2023 /PRNewswire/ -- A Marburg virus vaccine tested at Texas Biomedical Research Institute (Texas Biomed) is progressing in clinical trials, moving a step closer towards becoming the world's first vaccine against the deadly virus.
The Sabin Vaccine Institute recently announced it
launched Phase 2 clinical trials of its Marburg virus vaccine, which will initially enroll 125 healthy volunteers in Uganda and Kenya. Early tests demonstrating the vaccine's efficacy, safety and optimal dosage were completed at Texas Biomed and elsewhere in animal models, which are essential before any vaccine or therapy can be administered in humans.
"We have been partnering with Sabin since 2019 and are very excited to see their Marburg vaccine candidate move into Phase 2 clinical trials," says Ricardo Carrion, Jr., PhD, the Director of Maximum Containment Contract Research at Texas Biomed. "An effective vaccine is critical to protect people from this deadly virus, especially as we see the frequency of outbreaks increasing in more places."
Marburg virus is a part of the same filovirus family as Ebola virus and causes severe hemorrhagic fever. It is extremely deadly with up to a 90% fatality rate. Two outbreaks occurred earlier this year: an outbreak in
Equatorial Guinea killed 12 out of 17 confirmed cases, with another 23 probable deaths, according to the World Health Organization.
Tanzania also saw its first-ever Marburg outbreak, which killed six out of eight confirmed cases.
First documented in 1967, Marburg has cropped up more than a dozen times over the past 56 years. There is no approved vaccine or treatment.
Texas Biomed's scientists led the development of the well-characterized nonhuman primate
model for Marburg, conducting the foundational studies needed to accurately evaluate vaccines and therapies against the virus in macaques. The work was completed in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), the federal agency that oversees the development of biodefense countermeasures.
Texas Biomed has a well-established biosafety level 4 (BSL-4) laboratory, which is the highest level of biocontainment and is required to work on deadly airborne pathogens that have no vaccines or cures such as Marburg virus.
"We applaud our partners at Sabin on this significant milestone and are proud that our specialized expertise in biocontainment, filoviruses and animal model development has helped advance Sabin's vaccine candidate forward," says Cory Hallam, PhD, Executive Vice President for Applied Science and Innovation at Texas Biomed.
The Phase 2 clinical trial will build on promising results from preclinical studies and a smaller Phase 1 clinical trial. Texas Biomed continues to partner with Sabin to gather more detailed information that can only be gained through tightly controlled animal studies, including how soon protection is induced after being vaccinated.
"In an outbreak situation, the virus is spreading rapidly, so it is important to know how soon after receiving the vaccine a person would expect to be protected," says Dr. Carrion.
Texas Biomed has
conducted similar work on Sabin's closely-related Sudan ebolavirus vaccine, which was delivered to Uganda last year as part of a World Health Organization-coordinated outbreak response.
Texas Biomed is a nonprofit research institute focused on infectious diseases. Through basic research, preclinical testing and innovative partnerships, Texas Biomed accelerates diagnostics, therapies and vaccines for the world's deadliest pathogens.
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