The George Washington University (GW) School of Medicine and Health Sciences (SMHS) in the US is set to conduct the clinical trial of an investigational vaccine for prevention of the Zika infection in Brazil.
Leidos Biomedical Research has provided a grant of more than $2m to the university’s research team, which is led by SMHS associate professor David Diemert and professor Jeffrey Bethony.
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The randomised Phase II/IIB trial will enrol approximately 100 participants and is being conducted at the Hospital das Clínicas and the Fundação Oswaldo Cruz in Belo Horizonte in the country.
Designed to monitor transmission of the virus, the trial will involve a total of 2,400 subjects at various sites in Central and South America, Puerto Rico, and southern US.
The trial is sponsored by the National Institutes of Health (NIH) National Institute of Allergy and Infectious Disease (NIAID) and could further recruit additional participants at sites with higher infection rates.
Diemert said: “We are going into what is expected to be the transmission season in Brazil. 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 investigational agent of the trial is a DNA vaccine developed by the NIH to trigger an antibody response using the genetic material of a microbe.
During the trial, the vaccine’s safety, efficacy, and tolerability will be compared to placebo.
After administration of the vaccine, the subjects will undergo a follow-up period of two years, while the trial is scheduled for a duration of three years.
