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news.VaxInnate has announced that its M2e universal influenza vaccine candidate was safe and immunogenic in its first Phase I clinical trial, raising hopes for a universal influenza vaccine that could provide protection against seasonal and pandemic influenza strains.
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A total of 60 healthy young adults participated in the double-blind, dose-escalating Phase I study, which was designed to assess the safety and immunogenicity of the M2e universal influenza vaccine candidate in dosages of 0.3ug, 1ug, 3ug and 10ug injected 28 days apart.
The trial was also designed to assess VaxInnate’s approach to developing and producing flu vaccines, which is based upon a proprietary combination of toll-like receptor-mediated immune enhancement and recombinant bacterial production of vaccine antigen. According to the company, this proprietary technology could significantly reduce the time required to produce vaccine supplies sufficient to meet national and even global needs.
Alan Shaw, CEO of VaxInnate, said: “We’re very pleased with the study data, which demonstrate that VaxInnate’s M2e universal flu vaccine candidate is safe and capable of eliciting a more potent immune response by delivering a one-two punch that triggers both arms of the body’s immune defense.
“Furthermore, it accomplishes this at doses below a microgram of vaccine antigen and without the use of conventional adjuvants. In short, this vaccine candidate has passed a critical initial test with data that have exceeded our expectations.”