https://www.theguardian.com/world/2016/jun/20/human-testing-experimental-zika-vaccine-virus
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Inovio Pharmaceuticals receives FDA clearance to start 40-person study
DNA-based vaccine aims to stimulate antibodies by mimicking Zika virus
Scientists expect to test the first experimental Zika vaccine on humans in the coming weeks, after the pharmaceutical company Inovio received approval from the US Food and Drug Administration to start a small clinical trial.
Zika, which is a mosquito-borne virus, can cause severe birth defects, is linked with the muscle paralysis syndrome Guillain-Barré, and is now endemic in much of Latin America.
Inovio plans to enroll 40 healthy adults in its trial. Research will focus on safety, dosage and the body’s immune response to the vaccine, the company said. Such research is typical of a “phase one” trial, as scientists call such early work.
Researchers would probably need several trials to prove the vaccine is safe, effective and provided at the right dose. Testing on “small and large animals” has already occurred, the company said. The experimental vaccine, called GLS-5700, uses synthetic fragments of virus DNA to provoke an immune response in the body.
Scientists first started sounding the alarm about Zika early in 2016, when a link appeared with microcephaly, an uncommon birth defect where children are born with abnormally small heads and severe developmental impairment.
By April, scientists at the Centers for Disease Control and Prevention confirmed Zika was the cause of the birth defects. By June, the World Health Organization reported more than 1,500 cases of microcephaly in Brazil, which has by far the largest number, and that mosquitoes in more than 60 countries carried the disease.
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