First-in-Human Zika Vaccine Clinical Trial Approved
Inovio Pharmaceuticals, Inc. and GeneOne Life Science, Inc. got approval for the initiation of Phase I in-human clinical trial to evaluate Inovio’s Zika DNA vaccine (GLS-5700) in order to prevent infection from Zika virus.
The synthetic vaccine triggered powerful antibody and T-helper cell responses in animal models during preclinical testing, this clearly explains the product’s potential to prevent infection from Zika virus in humans.
CELLECTRA®, Inovio’s proprietary DNA delivery device will be used for intradermal administration of GLS-5700 in the Phase I trial. The tolerability, safety and immunogenicity profile of GLS-5700 will be studied in 40 volunteers during the trial.
Figure 1. CELLECTRA® DNA delivery device (photo credit: Inovio Pharmaceuticals, Inc. and GeneOne Life Science, Inc.).
CELLECTRA® working is based on electroporation principle in which it releases millisecond electrical pulses to the injection site in a controlled manner. This creates temporary pores in cell membranes and thus allow highly efficient cellular uptake of plasmid DNA into cells.
Figure 2. Mechanism of plasmid DNA delivery by CELLECTRA® (photo credit: GeneOne Life Science, Inc.).
This effect of CELLECTRA® lead to an improved in vivo delivery of plasmid DNA and improvement in immunogenicity of DNA vaccine.
Figure 3. The effect of CELLECTRA® (photo credit: GeneOne Life Science, Inc.).
Academic collaborators from the USA and Canada are associated with Inovio and GeneOne for the development and growth of Zika vaccine, GLS-5700. Previously, Inovio and GeneOne had collaborated with them for the development of Inovio’s Ebola and MERS vaccines.
Dr. J. Joseph Kim, Inovio’s President & CEO, said, “We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers. As of May 2016, 58 countries and territories reported continuing mosquito-borne transmission of the Zika virus; the incidences of viral infection and medical conditions caused by the virus are expanding, not contracting. We plan to dose our first subjects in the next weeks and expect to report phase I interim results later this year.”
Till now, Indian vaccines maker Bharat Biotech, National Institutes of Health (NIH) and Sanofi were in neck to neck competition for bringing the first vaccine for Zika virus infection to the market.Now with the entry of Inovio’s GLS-5700 in the Phase I trial it seems to have taken the lead. NIH is planning to start human trial on its product this year.
Though still there is no vaccine or therapy available for Zika virus infection but slowly and steadily the wagon of remedy is moving towards its destination. Lets see what happens next!
Featured Image credit: Zika virus infographic include transmission worldwide. © kristypolsk (BigStock Photo ID: 124422704)