NIH kicks off PhI trial for Zika vax as caseload rises in U.S.


As the number of Zika cases continues to rise in the U.S., researchers at the National Institutes of Health are launching a clinical trial of a vaccine meant to ward off the virus and prevent serious complications in infants.

The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) will run an early-stage study of the investigational DNA vaccine for Zika at three study sites in the U.S., including its Bethesda, MD-based clinical center. Researchers plan to enroll at least 80 healthy volunteers between the ages of 18-35, the NIAID announced Wednesday.

Ultimately, the trial will show whether the vaccine is safe and can trigger an immune system response in subjects, the NIH said in a statement. The hope is that the jab could stop the virus from spreading and prevent microcephaly, a birth defect that causes small head size in infants born to mothers with Zika.

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The trial responds to a growing healthcare problem. More than 50 countries and territories have reported Zika transmission, according to CDC numbers cited by the NIH. In the U.S., at least 6,400 cases were reported.

“A safe and effective vaccine to prevent Zika virus infection and the devastating birth defects it causes is a public health imperative,” NIAID Director Anthony Fauci said in a statement.

NIAID will use a similar method to develop its investigational DNA Zika vaccine as it did to make another one for West Nile virus. Researchers found the latter jab safe in a Phase I clinical trial.

Even though “it will take some time” before a Zika vaccine is ready for the market, the trial marks “an important step forward,” Fauci said. Researchers plan to report out initial safety data by January 2017.

If all goes to plan, NIAID will kick off a Phase II clinical trial of the vaccine in countries with Zika virus in early 2017, the NIH said. 

Meanwhile, some pharma companies are already working to develop a Zika vaccine. Inovio Pharmaceuticals ($INO) recently moved into the first human trials with its candidate. In June, Emergent BioSolutions got a BARDA contract worth up to $21.9 million to develop a Zika vaccine for a Phase I trial.

Bigger names such as GlaxoSmithKline ($GSK) and Sanofi ($SNY) are also jumping on the Zika vaccine bandwagon. Last month, GSK announced that it would work with the NIH on a Zika R&D project at its new vaccine research hub in Rockville, MD.

The announcement followed a similar move from Sanofi. The pharma giant the same week said that it would work with the U.S. Army’s Walter Reed Army Institute of Reseach to further an inactivated Zika virus vaccine candidate. Sanofi is also developing its own Zika vaccine candidate separately.

- read the NIH’s statement

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