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Phase 1 trial begins for Marburg virus vaccine

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Melinda Hamer

The Walter Reed Army Institute of Research, or WRAIR, began a phase 1 clinical trial to evaluate the safety and tolerability of two different doses of a Marburg vaccine candidate in humans and determine if the vaccine generates enough antibodies and T-cell responses to the Marburg virus.

The vaccine candidate, VRC-MARADC087-00-VP, was developed by the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center.

“In today’s global environment of mass migration and rapid international travel, infectious diseases can spread with astonishing speed and impact. Development of an effective vaccine against Marburg virus is a critical public health and global health security need” Lt. Col. Melinda Hamer, MD, MPH, chief of WRAIR Clinical Trials Center in Silver Springs, Maryland, told Infectious Disease News.

According to a news release, study of the recombinant chimpanzee adenovirus type-3 vectored Marburg virus vaccine will include splitting 40 healthy adult volunteers into two groups to test two different doses of the vaccine.

Volunteers will be monitored for 1 year for signs of immune system response to determine the durability of those responses and the safety of each dosage. Additional objectives of the study are to evaluate vaccine-induced mRNA expression and to isolate monoclonal antibodies to the Marburg virus, which may prove useful in the prevention or treatment of Marburg, Hamer said.

The most recent outbreak of Marburg virus struck Uganda in 2017. According to the news release, Marburg outbreaks have resulted in case fatality rates between 24% and 88%. The Marburg virus, like the Ebola virus, causes severe hemorrhagic fever.

“This study is an example of the Department of Defense and NIH working in an interagency process to rapidly develop and test a vaccine in response to a critical emerging infectious disease threat,” Hamer said. “This effort is also an example of remarkable speed in modern translational medicine, quickly moving from laboratory and preclinical animal studies to develop a safe product for testing in human subjects.” – by Erin Michael

Disclosure: Hamer reports no relevant financial disclosures.