Date: 2016-01-28
Type of
information: Initiation of patient enrollment
phase: 1
Announcement: initiation of patient enrollment
Company: Inovio Pharmaceuticals (USA - PA) GeneOne Life Science (Republic of Korea)
Product: MERS vaccine (GLS-5300)
Action
mechanism: vaccine/plasmid. GLS-5300 is a DNA plasmid vaccine that expresses the MERS coronavirus spike (S) glycoprotein.
Disease: Middle East respiratory syndrome (MERS)
Therapeutic
area: Infectious diseases - Respiratory diseases
Country: USA
Trial
details: This study will evaluate the safety of GLS-5300 at one of three dose levels following a three-injection vaccination regimen followed by electroporation. The study will also assess immune responses over a 1 year period with respect to the generation of antibody and cellular responses. (NCT02670187)
Latest
news:
- • On December 6, 2016, Inovio Pharmaceuticals announced that the International Vaccine Institute (IVI) will provide new funding and support to further advance GLS-5300, Inovio’s vaccine to prevent Middle East Respiratory Syndrome (MERS) virus infection. IVI will add technical, laboratory and financial support for GLS-5300 clinical trials in Korea.
- Inovio, GeneOne and its academic collaborators have evaluated GLS-5300 in mice, rhesus macaques and camels. As published in Science Translational Medicine, the vaccine induced robust immune responses in all three species. GLS-5300 has been specifically able to induce 100% protection from a live virus challenge in a rhesus macaque non-human primate study. The results of the non-human primate study supported the conduct of the first phase I clinical trial of 75 healthy volunteers in collaboration with the Walter Reed Army Institute of Research.
- • On January 28, 2016, Inovio Pharmaceuticals announced the beginning of recruitment for its collaborative vaccine study for MERS (Middle East Respiratory Syndrome). Inovio and GeneOne Life Science are co-developing Inovio’s MERS vaccine (GLS-5300) in partnership with the Walter Reed Army Institute of Research (WRAIR) in Maryland, where the trial is being conducted. The primary and secondary goals of this first-in-man phase I trial are to obtain safety and immunogenicity data. This trial represents the first MERS vaccine to be tested in humans for this disease that has no approved vaccines or treatments.
Last year, GLS-5300 induced 100% protection from a live virus challenge in a rhesus macaque non-human primate study. Inovio and its collaborators evaluated its MERS vaccine in mice, camels as well as non-human primates. As published in Science Translational Medicine, the vaccine induced robust immune responses capable of preventing the virus from infecting cells in all three species. In monkeys, all vaccinated animals in the study were protected from symptoms of MERS when challenged with a live MERS virus.
Middle East Respiratory Syndrome is caused by a coronavirus that is related to the severe acute respiratory syndrome (SARS). While SARS infected more than 8,000 people, the disease was short-lived between 2002 and 2004 and had a mortality rate of about 10%. Since 2012, MERS has infected over 1,600 people, with almost 600 deaths, a mortality rate of about 40%, and is still ongoing. Highlighting the global concern for MERS, in the summer of 2015 a single business person returned to South Korea from Saudi Arabia and was the index case for a country-wide epidemic involving 186 persons with a 20% mortality rate.
- * On October 19, 2015 , GeneOne Life Science which partnered with Inovio Pharmaceuticals to develop Inovio’s MERS vaccine (GLS-5300), announced the filing of an Investigational New Drug Application (IND) for GLS-5300 with the FDA. The companies expect to move the MERS vaccine into a phase I clinical trial in healthy volunteers before year end.
Is
general: Yes
