A research team at the George Washington University (GW) School of Medicine and Health Sciences (SMHS) was recently awarded more than $2 million from Leidos Biomedical Research, Inc. to begin a Zika virus vaccine trial in Brazil.
Led by David Diemert and Jeffrey Bethony, both professors of microbiology, immunology, and tropical medicine at SMHS, the research team is partnering with the Brazil-based Hospital das Clinicas and the Fundação Oswaldo Cruz in Belo Horizonte, Brazil to enroll 100 subjects for the trial.
In total, the trial will include 2,400 individuals across a number of testing sites in Central and South America, Puerto Rico and the southern United States.
The vaccine candidate being evaluated, a DNA-based vaccine, was developed by the U.S. National Institutes of Health (NIH).
For the Phase 2/2B study, the researchers will monitor the transmission of the virus in each selected area as well as evaluate the safety, tolerability, and efficacy of the vaccine compared to a placebo. Each subject will then be monitored for a two year period.
“We are going into what is expected to be the transmission season in Brazil,” Diemert said. “That’s one of the reasons we are heading into this trial now. The people in these areas will be vaccinated before we would start to see cases of Zika.”
Unlike previous Zika vaccine candidates, the DNA-based vaccine can be given to pregnant women without the risk that live virus-based vaccines pose to fetuses, such as Congenital Zika Syndrome.
“Some people will get Zika and are asymptomatic,” Bethony said. “However, infection in a woman who is expecting could put the child at risk for microcephaly.”
Should the vaccine prove to be successful, the researchers said that the populations in endemic areas would see the potential for better prevention against Zika infection.