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Sanofi SA has formed a partnership with the U.S. Army to expand research and development of an experimental Zika vaccine that has shown promise in early laboratory studies and is among a few candidates expected to be tested on humans in the coming months.

At least 15 companies and entities, including Sanofi, are racing to develop vaccines against the Zika virus, which is behind an epidemic in the Americas that the World Health Organization says constitutes a public health emergency because the virus is linked to birth defects in multiple countries.

The experimental vaccine developed by scientists at the Walter Reed Army Institute of Research in Silver Spring, Md., and now to be advanced by Sanofi, is one of the furthest along.

Made from a whole virus that has been killed, or inactivated, it is based on a technology that has been used on vaccines that have been licensed against viruses related to Zika, such as Japanese encephalitis, said Col. Stephen Thomas, the institute's Zika program lead. "It was a playbook that we've run before," he said. The technology has also been used for years for flu, polio and other vaccines.

The experimental Zika vaccine will be tested on humans in a Phase I clinical trial starting in October that will be funded by the U.S. government, said Col. Nelson Michael, co-lead of the institute's Zika program.

A single dose of the vaccine developed by the Army institute fully protected mice in a study published last week in the journal Nature, a finding that suggests an effective vaccine against Zika can be made. "The protection was striking," said Dan Barouch, professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School, who led the study. The study examined the Army vaccine as well as another that Dr. Barouch's lab developed.

The experimental vaccine developed by the Army institute is the second that Sanofi is pursuing for Zika. The Paris-based company is also conducting preclinical studies on a vaccine that is based on a technology it used to develop treatments against dengue and Japanese encephalitis. But that vaccine will take longer to develop and get to market than other approaches, Sanofi said. The technology is different from the one employed by the Army institute for its Zika vaccine.

"In addition to exploring our own vaccine technology used in our new dengue fever vaccine, we are looking at other pathways to get a Zika vaccine into the clinic as soon as possible," said David Loew, executive vice president of Sanofi Pasteur, the French drugmaker's vaccine unit.

Under the agreement, the Army will transfer its technology for the vaccine candidate to Sanofi Pasteur, which will take on advanced clinical development, develop a manufacturing process, and handle other matters related to testing, regulatory approval, and production of the vaccine.

Researchers and companies are racing to get a vaccine to market as quickly as possible—though they caution it is likely to take three years or more before that happens. While the virus makes most people only mildly ill, if it makes them sick at all, it can cause severe brain damage in the fetuses and infants of women who are infected during their pregnancies. In adults, it has been linked to an increase in cases of Guillain-Barre syndrome, a rare immune disorder.

The WHO says that 61 countries and territories have reported ongoing transmission of the virus, and 12 countries and territories have reported Zika-related birth defects.

Inovio Pharmaceuticals Inc. and GeneOne Life Science Inc., a South Korean biopharmaceutical company, said last month that they plan to start a human clinical trial of a vaccine candidate in the coming weeks. The National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health, has said it would start human clinical trials on a vaccine candidate by September. The Biomedical Advanced Research and Development Authority, a division of the U.S. Department of Health and Human Services, is developing a Zika vaccine with Brazil's Butantan Institute.

Vaccine developers have numerous questions to address: how much of a market there will be for a vaccine against an infection that generally produces mild, short-lived symptoms; whether and how to protect pregnant women; and possible cross-reactions with related viruses such as dengue. Scientists say their hope is to develop a vaccine that would be given regularly to women when they are young, so they develop immunity before their childbearing years.

A vaccine containing killed virus is potentially a safer bet for pregnant women, who are urged to avoid certain types of shots, said the Army institute's Dr. Thomas. "A killed vaccine has an inherently superior safety profile," he said.

Write to Betsy McKay at betsy.mckay@wsj.com and Noemie Bisserbe at noemie.bisserbe@wsj.com

(END) Dow Jones Newswires

July 06, 2016 01:25 ET (05:25 GMT)

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