Agencies within the Defense Department are hard at work on a potential Ebola vaccine, with safety testing on humans expected to begin as early as next week.
The Pentagon recently received approval from the Food and Drug Administration to start testing the vaccine, VSVΔG-ZEBOV or BPSC1001, for health risks and side effects on people.
It already has been tested for safety as well as performance against the deadly disease in animals, a defense official said Friday.
VSVΔG-ZEBOV was developed by the Public Health Agency of Canada’s National Microbiology Laboratory in collaboration with the Defense Threat Reduction Agency, DTRA, and Newlink Genetics Corp. The vaccine combines a portion of the protective protein coating of the Ebola virus with another pathogen — vesicular stomatitis virus — to stimulate an immune response against Ebola.
The work will be conducted at the Clinical Trials Center at the Walter Reed Army Institute of Research, Silver Spring, Maryland.
Last month, the National Institutes of Health began human safety tests on a different potential vaccine, called NIAID/GSK Ebola vaccine.
That vaccine, co-developed by the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline, combines a vaccine vector — essentially a carrier to deliver the material needed to evoke an immune response (in this case, chimp adenovirus type 3) — with genetic material from two strains of Ebola: Sudan Ebola and Zaire Ebola, the virus responsible for the current outbreak.
“We know the best way to prevent the spread of Ebola infection is through public health measures, including good infection control practices, isolation, contact tracing, quarantine, and provision of personal protective equipment,” NIAID Director Dr. Anthony Fauci said in a news release. “However, a vaccine will ultimately be an important tool in the prevention effort. The launch of Phase 1 Ebola vaccine studies is the first step in a long process.”
The U.S. government, and in particular DoD, has played a major role in identifying and testing the Ebola virus and developing treatments for infection.
The experimental ZMAPP treatment administered successfully to five infected individuals in the recent outbreak was developed by MAPP Pharmaceuticals of San Diego along with Reynolds American subsidiary Kentucky Bioprocessing under a DTRA and NIH contract.
Another experimental treatment, TKM-Ebola, made by Canadian company Tekmira Pharmaceuticals, was developed under a $140 million contract with DoD; the FDA is examining procedures that would allow it to be used in infected patients without full FDA approval.
The U.S. Naval Medical Research Center has established two Ebola testing facilities in the region and service members continue to build a hospital for infected medical personnel, slated to open Oct. 18.
Construction of two treatment centers for other victims also is underway, Pentagon spokesman Rear Adm. John Kirby said Friday.
More than 3,400 people have died in West Africa from Ebola; more than 7,470 have been infected.
Pentagon officials who discussed the military’s role in developing treatments and vaccines for Ebola said last week that the FDA will have the final say in determining whether any vaccine or treatment is safe and can advance in the trial process or be used experimentally.
Although the VSVΔG-ZEBOV vaccine is in safety trials, researchers must follow strict guidance and protocols for development because unlike ZMAPP or other experimental treatments, which are given to infected individuals, potential vaccines are tested on healthy people.
“If a vaccine stops Ebola but has dangerous side effects in humans, that is not a good vaccine,” the defense official said.