Zika Resource Center
Zika Resource Center
August 13, 2016
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NIAID launches trial testing Zika vaccine for humans

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The National Institute of Allergy and Infectious Diseases announced the launch of a phase 1 clinical trial — VRC 319 — to study the safety and efficacy of an investigational DNA vaccine for the prevention of Zika virus, according to a press release.

The clinical trial will be led by Julie E. Ledgerwood, DO, chief of the clinical trials program in the NIAID’s Vaccine Research Center, and will include at least 80 healthy volunteers between the ages of 18 and 35 years dosed with the same amount of vaccine — a plasmid that was engineered and contains genes that code proteins of the Zika virus.

Julie E. Ledgerwood, DO

Julie E. Ledgerwood

“A team of scientists here at NIAID worked tirelessly to rapidly develop this vaccine for clinical testing,” John Mascola, MD, director of NIAID’s Vaccine Research Center. “DNA or gene-based vaccines induce antibodies, but they also can activate the cell-mediated immune response, which ultimately could yield strong and durable protection against disease.”

During the trial, volunteers will be divided randomly into four study groups of 20 each. All volunteers will receive a vaccination at the first visit and then half will receive an additional vaccination 8 or 12 weeks later. The remaining volunteers will receive two additional vaccinations: one group of 20 volunteers will receive a second one at 4 weeks and a third at 8 weeks, whereas the other 20 volunteers will receive a second vaccine at 4 weeks and a third at 20 weeks.

The clinical trial is part of the U.S. government’s response to the ongoing outbreak of Zika virus in the U.S., according to the release. More than 6,400 Zika cases have been reported in the U.S. and its territories, and there are currently no vaccines or medications to prevent or treat Zika virus.

Anthony S. Fauci, MD

Anthony S. Fauci

“A safe and effective vaccine to prevent Zika virus infection and the devastating birth defects it causes is a public health imperative,” Anthony S. Fauci, MD, director of the NIAID, said in the release. “NIAID worked expeditiously to ready a vaccine candidate, and results in animal testing have been very encouraging. We are pleased that we are now able to proceed with this initial study in people. Although it will take some time before a vaccine against Zika is commercially available, the launch of this study is an important step forward.”

If the results are favorable, NIAID plans to initiate a phase 2 clinical trial in Zika-endemic countries in 2017, according to the release.

Disclosure: Fauci, Ledgerwood and Mascola are employed by the NIH.