A School of Medicine and Health Sciences team was awarded $2 million to bring a clinical trial to Brazil.
A team of School of Medicine and Health Sciences researchers were awarded more than $2 million to facilitate a vaccine trial in Brazil. The country has been hit hard by the mosquito-borne illness, which is linked to birth defects.
Researchers were awarded funding from Leidos Biomedical Research, Inc. The trial is also sponsored by the National Institute of Allergy and Infectious Disease of the National Institutes of Health.
The world became widely aware of the Zika virus in 2016 when an epidemic spread rapidly throughout South and Central America and cases were reported by travelers returning from this region to the United States. Since that outbreak, new Zika outbreaks have also been reported in Asia.
David Diemert, associate professor of microbiology, immunology and tropical medicine at SMHS, will lead the research team alongside Jeffrey Bethony, SMHS professor of microbiology, immunology and tropical medicine. They are partnering with the Hospital das Clínicas and the Fundação Oswaldo Cruz in Belo Horizonte, Brazil, to enroll 100 subjects into the clinical trial.
The trial will include 2,400 total subjects across sites in Central and South America, Puerto Rico and the southern United States. During the study, transmission of the virus will be monitored and additional volunteers may be signed up at sites with higher rates of infection.
“We are going into what is expected to be the transmission season in Brazil,” Dr. 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.”
The vaccine being tested by the GW team was developed by the NIH.
Researchers will evaluate the safety and tolerability of the vaccine, as well as the efficacy of the vaccine compared to placebo, over the course of the trial. The vaccine is a DNA vaccine, which elicits a strong antibody response using a microbe’s genetic material. The DNA vaccine can be given to pregnant women, whereas a vaccine that contains a live virus could pose a risk to the fetus if administered during pregnancy.
Zika in pregnant women is linked to fetal birth defects like microcephaly, a condition where a baby’s head is significantly smaller than typical due to abnormal brain development.
“The main concern about Zika virus infection is Congenital Zika syndrome,” Dr. Bethony said. “Some people will get Zika and be asymptomatic. However, infection in a woman who is expecting could put the child at risk for microcephaly.”
Subjects who receive the injections will then be followed for a two-year period. Following the trial, if the vaccine is determined successful, the populations in these endemic areas will see the potential for better prevention against infection with the Zika virus.
The study, “A Phase 2/2B, Randomized Trial to Evaluate Safety, Immunogenicity, and Efficacy of a Zika Virus DNA Vaccine in Healthy Adults and Adolescents,” will take place over a three-year period.