The cataclysm caused by the COVID-19 pandemic has impacted on clinical trials in terms of alternatives for study participants, enhanced operational and financial support for progressively more complex trial protocol designs and greater collaboration among sponsors.
Therefore, presented here is a sample of the summarised report of new candidate antiviral and vaccine therapies undergoing clinical trials worldwide as from the week 4 to 8 May 2020 in the pursuit of gaining regulatory approval for treatment and/or prophylaxis against SARS-CoV-2 coronavirus infection.
For this Phase I U.S. based clinical trial, all 40 healthy volunteers have had their first dose of the COVID-19 DNA vaccine INO-4800 as announced 29 April last month. Interim immune responses and safety data are anticipated to be published late next month. The 40 participants were enrolled at the University of Pennsylvania in Philadelphia, PA, and at a clinic in Kansas City, MO, USA. Each participant will be administered two doses of INO-4800 four weeks apart. The primary study objective of this Phase I trial will be to assess the safety profile and immunogenicity of INO-4800 in anticipation of advancing rapidly to a Phase II/III efficacy study, which is due to be potentially initiated this summer 2020.
INO-4800 is the sponsor's DNA vaccine candidate designed to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19 infection. The creation of INO-4800 has been accelerated using sponsor's proprietary DNA medicine platform after the publication of the genetic sequence of the coronavirus that causes COVID-19. The sponsor has prior experience of working with coronaviruses and is the only company with a vaccine in Phase IIa development for a related coronavirus that causes Middle East Respiratory Syndrome (MERS) infection.
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