The Hope Clinic of the Emory Vaccine Center will be one of three U.S. study sites to participate in an NIH-sponsored clinical trial of a vaccine candidate intended to prevent Zika virus infection. The vaccine was developed by the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH).

The Phase I clinical trial, called VRC 319, will evaluate the experimental vaccine’s safety and ability to generate an immune system response in participants. At least 80 healthy volunteers ages 18-35 years will be enrolled at the three sites, including the NIH Clinical Center in Bethesda, Maryland; the Hope Clinic of the Emory Vaccine Center in Atlanta; and the University of Maryland Medical Center in Baltimore.

The vaccine includes a small, circular piece of DNA—called a plasmid—that scientists engineered to contain genes that code for proteins of the Zika virus. When the vaccine is injected into the arm muscle, cells read the genes and make Zika virus proteins, which self-assemble into virus-like particles. The body mounts an immune response to these particles, including neutralizing antibodies and T cells. DNA vaccines do not contain infectious material—so they cannot cause a vaccinated individual to become infected with Zika—and have been shown to be safe in previous clinical trials for other diseases.

In Atlanta, the clinical trial will be led by Infectious Disease physicians Srilatha Edupuganti, MD, and Nadine Rouphael, MD, at the Hope Clinic of Emory University School of Medicine.

"As recent events show, the Zika virus threat is growing rapidly in many countries, including the United States, says Edupuganti. "It is critical that we develop a vaccine against this disease, which has devastating consequences for the health of pregnant women and babies, and we are pleased to join this NIH clinical trial."

Initial safety and immunogenicity data from the Phase 1 trial are expected by January 2017. If results show a favorable safety profile and immune response, NIAID plans to initiate a Phase 2 trial in Zika-endemic countries in early 2017.

For more information about the NIH clinical trial, see Questions and Answers: Phase 1 Clinical Trial of NIAID Zika Virus investigational DNA vaccine, and ClinicalTrials.gov (identifier NCT02840487) or the NIH news release.

Emory plans to begin enrolling participants by the end of August.

For information about participating in the clinical trial at Emory, please e-mail vaccine@emory.edu or call the Emory Hope Clinic at 404-712-1371.