The National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, has launched human trials to test the safety and efficacy of a potential Zika vaccine.
The clinical trials are expected to include 80 healthy participants aged 18 to 35 years at three sites: Emory University in Atlanta, University of Maryland School of Medicine's Institute for Global Health in Baltimore and the NIH Clinical Center in Bethesda, Md. The 80 individuals will be divided into four groups of 20. All will be administered the vaccine on their first visit, half will receive an additional dose 8 to 12 weeks later, the remaining two groups will be given two additional vaccine doses — one group at week four and eight and the other at week four and week 20.
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The vaccine candidate contains a circular piece of engineered DNA which contains genes that create Zika virus proteins designed to incite an immune response from neutralizing antibodies and T cells. DNA vaccines like this one do not contain infectious materials and have displayed high levels of safety in clinical trials for other diseases.
"A safe and effective vaccine to prevent Zika virus infection and the devastating birth defects it causes is a public health imperative," said Anthony S. Fauci, MD, NIAID director. "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."
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