An investigational Zika vaccine developed by NIAID and the NIH enters phase 1 clinical trials.
At least 80 people between the ages of 18 and 35 years will be enrolled in the trial, which will take place at 3 study sites in the United States including the NIH Clinical Center in Bethesda, Maryland. The trial will test vaccine safety and immunogenicity.
Scientists at NIAID’s Vaccine Research Center developed the DNA vaccine, which does not contain Zika virus and therefore cannot cause an infection. The vaccine contains a genetically engineered plasmid—a small, circular piece of DNA—that encodes Zika virus proteins. These proteins assemble into viruslike particles that provoke an immune response against the virus. This response is composed of both neutralizing antibodies and T cells.
“NIAID worked expeditiously to ready a vaccine candidate, and results in animal testing have been very encouraging,” NIAID Director Anthony S. Fauci, MD, said in a statement (http://bit.ly/2bwrFDP). “Although it will take some time before a vaccine against Zika is commercially available, the launch of this study is an important step forward.”
Trial participants will be followed up for 2 years. A phase 2 trial in Zika-endemic countries is planned for early 2017, depending on the early results of the current trial.
NIAID is also supporting several other Zika vaccine candidates. NIAID will fund phase 1 trials of a whole-particle inactivated Zika virus vaccine developed at the Walter Reed Army Institute of Research, 2 of which will launch this fall and in early 2017.