FDA News

FDA approves first clinical trial evaluating Zika vaccine in humans

Inovio Pharmaceuticals and GeneOne Life Science announced that the FDA recently approved the launch of a phase 1 trial that will assess the safety, tolerability and immunogenicity of a Zika DNA vaccine in healthy volunteers, according to an Inovio representative.

The phase 1, open-label, dose-ranging trial is the first to evaluate a Zika vaccine in humans. The vaccine, GLS-5700, will be administered to 40 healthy participants intradermally with a DNA delivery device, according to a press release. GLS-5700 previously demonstrated robust antibody and T-cell responses in animal models during preclinical testing.

“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,” J. Joseph Kim, PhD, MBA, president and CEO of Inovio, said in the release. “We plan to dose our first subjects in the next weeks and expect to report phase 1 interim results later this year.”

Inovio Pharmaceuticals and GeneOne Life Science collaborated with academic partners from the United States and Canada for the vaccine’s development, the release said. The consortium previously worked together to advance vaccines against Ebola and Middle East respiratory syndrome, or MERS.

Disclosure: Kim is an employee of Inovio Pharmaceuticals.

Inovio Pharmaceuticals and GeneOne Life Science announced that the FDA recently approved the launch of a phase 1 trial that will assess the safety, tolerability and immunogenicity of a Zika DNA vaccine in healthy volunteers, according to an Inovio representative.

The phase 1, open-label, dose-ranging trial is the first to evaluate a Zika vaccine in humans. The vaccine, GLS-5700, will be administered to 40 healthy participants intradermally with a DNA delivery device, according to a press release. GLS-5700 previously demonstrated robust antibody and T-cell responses in animal models during preclinical testing.

“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,” J. Joseph Kim, PhD, MBA, president and CEO of Inovio, said in the release. “We plan to dose our first subjects in the next weeks and expect to report phase 1 interim results later this year.”

Inovio Pharmaceuticals and GeneOne Life Science collaborated with academic partners from the United States and Canada for the vaccine’s development, the release said. The consortium previously worked together to advance vaccines against Ebola and Middle East respiratory syndrome, or MERS.

Disclosure: Kim is an employee of Inovio Pharmaceuticals.

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