) said Tuesday that the first patients have been treated in its clinical study testing immune responses in elderly adults that were immunized with the company's H1N1 universal flu vaccine.
The phase 1 study will look at the ability of Inovio's SynCon vaccine alone, as well as in combination with the 2012 seasonal influenza vaccine, to generate protective levels of immune responses.
The company will also look at the vaccine's ability to generate specific antibody immune responses against unmatched flu strains, and T-cell immune responses that can be helpful in fighting the flu, especially for the elderly, which are absent from current flu vaccines.
Inovio's SynCon technology allows it to design synthetic vaccines with the potential to protect against unmatched sub-types and strains of pathogens, including newly emergent, unknown strains of a virus that will periodically emerge through mutation, as in the case of influenza.
The H3N2, H1N1, and Type B influenza strains represented in each year's seasonal influenza vaccine are updated annually, but only protect against a single strain within each of these subtypes.
When a selected strain mutates, the annual vaccine may not provide protection, as witnessed with the 2009 swine flu H1N1 pandemic.
The company noted that the population most susceptible to the flu, those over 65 years of age, represent about 90 per cent of annual flu deaths in the US as older people's immune systems are typically weaker.
The phase 1 open label study will take place at the University of Manitoba in Winnipeg, Canada, funded in part by a grant from the Canadian Institute of Health Research, Inovio said.
In the trial, 50 healthy elderly patients will be divided into three groups.
One group of 20 subjects will receive a 2 dose regimen of Inovio's H1N1 SynCon flu vaccine delivered using the company's own intradermal electroporation device, while a second group of 20 will receive one dose of Inovio's vaccine delivered using electroporation followed by a dose of the 2012 trivalent seasonal flu vaccine 24 weeks later.
The third group of 10 subjects will receive a placebo delivered by electroporation followed by a dose of the seasonal flu vaccine 24 weeks later.
The study will assess the tolerability, safety, and the immune responses of the different vaccination regimens.
"We recently reported protective levels of immune responses against six unmatched strains of influenza in our H5N1 clinical study and expect data in the third quarter from our second influenza study, which includes an H1N1 component and is being tested in a population less vulnerable to influenza," said president and CEO, Dr. J. Joseph Kim.
"Having achieved best-in-class T-cell responses against other diseases, we will also assess T-cell generation against influenza, which is widely believed to be an important avenue to increasing protection for the highly at-risk 65-plus population."
In January, the company reported it was moving closer to a "universal flu vaccine" as animal studies showed protective antibody immune responses against multiple H3N2 and Type B strains.
The data built on previous studies by the company, which reported that its H5N1 synthetic vaccine achieved hemagglutination inhibition (NYSE:HI) titers against six unmatched strains of this influenza subtype in a phase I human study.
With the vulnerability of elderly in mind, Inovio said the new clinical study will aim to assess the ability to generally induce stronger antibody responses, as well as provide universal cross-strain protection and stimulate a part of the immune system not triggered by conventional flu vaccines.
"There have been limited new vaccine innovations with the potential to better protect the elderly against influenza," said chief of the Special Pathogens Program at the Public Health Agency of Canada, and a principal investigator of his study, Dr. Gary P. Kobinger.
"We are pleased to conduct this trial to evaluate this potential breakthrough influenza vaccine technology."