The National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health, has launched a clinical trial of a vaccine intended to prevent Zika virus infection. The NIH is evaluating the experimental vaccine’s safety and its ability to generate an immune system response among clinical trial participants.
The number of confirmed Zika cases as of press time reached 15 in Miami and no vaccines or specific therapeutics to prevent or treat the virus currently exist.
NIH said participants in the clinical trial include more than 80 healthy volunteers ages 18-35 years old at three sites within the United States, including the NIH Clinical Center in Bethesda, Maryland. Earlier this year, scientists at NIAID’s Vaccine Research Center developed the investigational vaccine, dubbed the NIAID Zika virus investigational DNA vaccine.
[Update: athenahealth recasts Zika infection threat from 5,000 Floridians down to fewer than 2,000]
More than 50 countries and territories, including the U.S., have active Zika virus transmission, according to the U.S. Centers for Disease Control and Prevention. More than 6,400 Zika cases have been reported in the United States and its territories. Zika infections usually are asymptomatic, though some individuals experience mild illness lasting about a week. Zika virus infection during pregnancy can cause a serious birth defect called microcephaly, as well as other severe fetal defects of the brain and other organs.
“A safe and effective vaccine to prevent Zika virus infection and the devastating birth defects it causes is a public health imperative,” said NIAID director Anthony S. Fauci, MD. “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.”
The approach being used to the NIAID Zika virus investigational DNA vaccine is similar to that used for another investigational vaccine developed by NIAID for West Nile virus. That vaccine candidate was found to be safe and induced an immune response when tested in a Phase 1 clinical trial.
“A team of scientists here at NIAID worked tirelessly to rapidly develop this vaccine for clinical testing,” said John Mascola, MD, director of NIAID’s Vaccine Research Center, speaking of the Zika virus DNA vaccine. “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.”
Twitter: @SiwickiHealthIT
Email the writer: bill.siwicki@himssmedia.com
