Government and Regulations

Zika Vaccine Developed by Walter Reed Researchers Shows Promise

A single dose completely protected mice against a major viral strain responsible for the outbreak in Brazil.


 

The Walter Reed Army Institute of Research (WRAIR) is teaming up with the vaccine division of Sanofi Pasteur to co-develop a Zika virus vaccine. The vaccine is one of 2 vaccines that showed promise in a test on mice; the other is being developed by Dan Barouch and colleagues of Beth Israel Deaconess Medical Center in Boston.

Data concerning the 2 vaccines effectiveness in laboratory testing were published in the June 28 issue of Nature. “These data demonstrate that protection against the Zika virus challenge can be achieved by single-shot subunit and inactivated virus vaccines in mice and that Env-specific antibody titers represent key immunologic correlates of protection,” Larocca and colleagues reported. “Our findings suggest that the development of a ZIKV vaccine for humans will likely be readily achievable.”

The WRAIR researchers developed the vaccine in close collaboration with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The vaccine was created from a purified, inactivated Zika virus.

“[It] has been proven to be safe, effective and able to meet regulatory requirements of the U.S. Food and Drug Administration,” Army COL Stephen J. Thomas, MD, an infectious diseases physician, vaccinologist, and the WRAIR Zika program lead told DoD News.

According to the agreement between Sanofi Pasteur and WRAIR, the organizations will share data related to the development of immunologic assays designed to measure neutralizing antibody responses following natural infection and immunization with the vaccine candidate, biologic samples generated during the performance of nonhuman primate studies, and biologic samples generated during the performance of human safety and immunogenicity studies.

In addition, the company will provide production of clinical material in compliance with current GMP (good manufacturing processes) to support phase II testing. “We’re looking at this from both a short- and long-term perspective, collaborating to get into the clinic quicker to provide a vaccine in response to the current emergency,” said John Shiver, PhD, senior vice president of R&D at Sanofi Pasteur.

David Loew, head of Sanofi Pasteur, commented,“In addition to exploring our own vaccine technology...we are looking at other pathways to get a Zika vaccine into the clinic as soon as possible”." Loew added, “This exciting collaboration with the WRAIR creates the opportunity to rapidly move forward.”

According to the NIH, later this year NIAID and WRAIR expect to start 2 clinical trials of inactivated viral vaccines, including the one described in the Nature study. The trials, each involving dozens of volunteers, will test whether the vaccines are safe and elicit an immune response in people.

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