Baltimore biotechnology company Profectus BioSciences is testing a vaccine to guard against the Ebola virus on 39 human subjects, a first step toward administering it more broadly to people at risk of exposure to the deadly pathogen.
The experiment is one of a handful to advance beyond trials on animal subjects.
The recent Ebola outbreak in Africa killed more than 11,000 people over two years. While several projects were expedited to human trials in West Africa as public health experts sought to stem the epidemic, Profectus is following a more traditional Food and Drug Administration review process.
That path could lead Profectus to human trials later this year testing a more comprehensive vaccine that protects against multiple strains of Ebola and a similar virus. After that, the company plans to test a freeze-dried vaccine that could be distributed in the field without refrigeration.
Profectus officials could not be reached for comment.
Under the first human trial, subjects will be divided into three groups that will receive progressively higher doses of the vaccine, and results will be compared to those of a placebo. Scientists are looking to establish whether the vaccine is safe and stimulates a response from the immune system.
The vaccine uses a modified version of an animal pathogen known as vesicular stomatitis virus to deliver genes from a key protein in the Ebola virus into the body. The protein prompts the immune system to build up an immune response to Ebola but cannot cause the disease.
It is a design similar to one used in a vaccine licensed by pharmaceutical giant Merck that was tested on 6,000 health care workers in advanced clinical trials in Sierra Leone.
Other vaccine candidates include one developed by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases and GlaxoSmithKline that was tested on volunteers at the University of Maryland, Baltimore in 2014.
No vaccine candidates have received FDA or other approvals for use in humans.
Profectus has received $55 million from government health and defense agencies for its Ebola vaccine work, including the federal Defense Department’s Medical Countermeasures Systems Joint Vaccine Acquisition Program and the National Institutes of Health.
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