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In US’ second clinical human testing for COVID-19 vaccines, a new vaccine candidate entered Phase 1 clinical human testing on Monday after the US Food and Drug Administration (FDA) accepted Inovio Pharmaceuticals’ Investigational New Drug (IND) application for INO-4800 vaccine candidate.
The company, backed by collaborators that include the Bill and Melinda Gates foundation is testing its DNA vaccine candidate designed to prevent COVID-19 infection with clinical testing in healthy volunteers beginning this week.
It will enrol up to 40 candidates in its Phase 1 study of the vaccines INO-4800 will enrol up to 40 in Philadelphia, PA (at the Perelman School of Medicine at the University of Pennsylvania) and Kansas City, MO (at the Center for Pharmaceutical Research).
Clnical Testing scope
“Each participant will receive two doses of INO-4800 four weeks apart, and the initial immune responses and safety data from the study are expected by late summer,” it said.
The company has based the virus on findings from its previous study for a DNA vaccine candidate for Middle East Respiratory Syndrome (MERS) which had shown promising results.
“Additional preclinical trials, including challenge studies, will continue in parallel with the Phase 1 clinical trial,” it further said.
The vaccine candidate works by injecting an independent genetic structure called plasmid into a patient. It helps the patient in producing an effective antibody that fights of the coronavirus infection.
The company will proceed on to Phase 2 after attaining initial safety and immunogenicity data from Phase 1 studies.
Other aspects of the project
Inovio plans to have one million doses of the vaccine available by year-end for additional trials and emergency use, pending appropriate regulatory guidance and funding, it said.
Apart from the Bill and Melinda Gates Foundation, the study is supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and VGXI, Inc., a wholly-owned subsidiary of GeneOne Life Science.
This is the second clinical trial for a COVID-19 vaccine with human volunteers. The US began its first human trial for a vaccine in March at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle where the first participant received an investigational vaccine to combat the virus which has now infected over 1.2 million people across the globe.
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