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The NIH has launched a Phase I clinical trial in humans of an investigational Zika vaccine.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced on August 3, 2016 that it has launched a clinical trial of a vaccine candidate intended to prevent Zika virus infection. The early-stage study will evaluate the experimental vaccine’s safety and ability to generate an immune response in participants, the NIH said in a press announcement.
The study has enrolled approximately 80 healthy volunteers ages 18–25 years old at three study sites in the United States. The NIAID Zika virus investigational DNA vaccine contains a small piece of plasmid that scientists have engineered to contain genes that code for the proteins of the Zika virus. When injected into the human body, the body’s cells read the genes and make Zika virus proteins, which create virus-like particles. This creates an immune response, including neutralizing antibodies and T-cells.
After receiving the injection, study participants will attend follow-up visits within a 44-week time period after the first vaccination. During these visits, scientists will take blood samples from patients and measure the immune response to the 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,” John Mascola, MD, director of NIAID’s Vaccine Research Center, said in a statement.
The Phase I Trial, VRC 319, will be led by Julie E. Ledgerwood, DO, chief of the VRC’s clinical trials program. Initial safety and immunogenicity data from the Phase I trial are expected by January 2017. If results show a favorable safety profile and immune response, NIAID plans to initiate a Phase II trial in Zika-endemic countries in early 2017.