Clinical Trials

Date: 2016-07-26

Type of information: Treatment of the first patient

phase: 1

Announcement: treatment of the first patient

Company: Inovio Pharmaceuticals (USA - PA) GeneOne Life Science (Republic of Korea)

Product: synthetic vaccine for the Zika virus GLS-5700

Action mechanism: DNA vaccine. GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. Inovio is developing its synthetic Zika vaccine with GeneOne Life Sciences and academic collaborators. Inovio synthetically generated DNA vaccine constructs targeting multiple Zika virus antigens using its SynCon vaccine technology. These SynCon constructs were administered using Inovio's CELLECTRA® electroporation delivery technology.  

Disease: Zika virus infection

Therapeutic area: Infectious diseases

Country: Canada, USA

Trial details:

• The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700.  ZIKA-001 is the first in man clinical trial of this vaccine which encodes for the premembrane-membrane and envelope regions of Zika virus. Zika virus, first discovered in the Zika forest in 1947, has caused a large epidemic in South America, Central America, and the Caribbean islands commencing in late 2014 or early 2015. Zika virus can cause significant neurologic disease to include Guillain Barre Syndrome in adults and microcephaly and other birth defects among children born to mothers who are infected during pregnancy. At present no vaccines or treatments have been approved for Zika virus infection. (NCT02809443)

Latest news:

• • On July 26, 2016, Inovio Pharmaceuticals announced the dosing of the first subject in its multi-center phase I trial to evaluate Inovio’s Zika DNA vaccine (GLS-5700). In addition to the previously announced US FDA approval for the conduct of the study, Health Canada’s Health Products and Food Branch has also approved this study, which will be conducted at clinical sites in Miami, Philadelphia, and Quebec City. This phase I, open-label, dose-ranging study of 40 healthy adult volunteers is evaluating the safety, tolerability and immunogenicity of GLS-5700 administered with the CELLECTRA®-3P device, Inovio’s proprietary intradermal DNA delivery device. Inovio expect to complete subject dosing and report interim phase I results later this year.
• • On June 20, 2016, Inovio Pharmaceuticals and GeneOne Life Science announced that they have received approval to initiate a phase I human trial to evaluate Inovio’s Zika DNA vaccine (GLS-5700) to prevent infection from this concerning virus. In preclinical testing this synthetic vaccine induced robust antibody and T cell responses in small and large animal models, demonstrating the product’s potential to prevent infection from this harmful pathogen in humans. This phase I, open-label, dose-ranging study with 40 healthy subjects will evaluate the safety, tolerability and immunogenicity of GLS-5700 administered intradermally with CELLECTRA®, Inovio’s proprietary DNA delivery device.
• • On May 16, 2016, Inovio Pharmaceuticals announced that testing of its synthetic vaccine for the Zika virus induced robust antibody and T cell responses in non-human primates (monkeys), demonstrating the product’s potential to prevent infection from this pathogen.
• Two doses of the Zika DNA vaccine delivered either intramuscularly or intradermally resulted in seroconversion, or the development of detectable specific antibodies in the blood, in all vaccinated non-human primates. Researchers also observed that vaccination generated robust and broad T cell responses as analyzed by the standardized T cell ELISPOT assay. These findings are vital given the potential importance of neutralizing antibodies in preventing infection and the role T cells play in clearing infection by killing cells that harbor the virus.
• • On February 17, 2016, Inovio Pharmaceuticals announced that preclinical testing of its synthetic vaccine for the Zika virus induced robust and durable immune responses, demonstrating the potential for a SynCon® vaccine to prevent and treat infections from this harmful pathogen. In this pre-clinical study, DNA vaccine constructs targeting multiple Zika virus antigens were synthetically generated using Inovio's SynCon® vaccine technology. These SynCon constructs were administered using Inovio's CELLECTRA® electroporation delivery technology. Inovio's Zika DNA vaccine resulted in seroconversion, or the development of detectable specific antibodies in the blood, in all vaccinated mice. Researchers also observed that vaccination generated robust and broad T cell responses as analyzed by the standardized T cell ELISPOT assay. These findings are vital given the potential importance of neutralizing antibodies in preventing infection and the role T cells play in clearing infection by killing cells that harbor the virus. Inovio now plans to initiate phase  I human testing of the  synthetic Zika vaccine before the end of 2016.

   

Is general: Yes