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Clinical Trials

Date: 2012-09-13

Type of information:

phase: 1

Announcement:

Company: Immune Targeting Systems (UK)

Product: Flunisyn® (pan-strain influenza-A T-cell vaccine)

Action mechanism: Flunisyn® vaccination stimulates the production of T-cells that recognise and destroy influenza-infected cells. In contrast, conventional influenza vaccines induce an antibody response against the virus (a “humoral” response). T-cell vaccines offer many clinical advantages over conventional vaccines, especially against rapidly mutating viruses, because they can promote immune responses to parts of the virus that do not change from one flu season to the next. Flunisyn™ is therefore applicable to multiple seasonal and pandemic influenza strains. The most conserved parts of the influenza virus are located within the internal regions of the virus particle that are not presented to the humoral arm of the immune system. This is why conventional vaccines, which only target the highly variable, external regions of the virus, have to be newly produced to counter the threat from each season’s circulating strain. Conventional influenza vaccines have several additional limitations, most notably, low efficacy in at-risk populations including the elderly, chronically ill and young children; Flunisyn® has been designed to address these limitations.

Disease: influenza

Therapeutic area: Infectious diseases

Country:

Trial details: The trial was a randomised, double-blind, placebo-controlled, escalating dose study in 48 healthy adult volunteers. The second trial was a randomised, double blind study to compare the immunogenicity of Flunisyn®, alone or with an undisclosed adjuvant, in 48 healthy adult volunteers. Both formulations generated strong cell-mediated immunity but with the adjuvant formulation generating enhanced responses.

Latest news: Immune Targeting Systems, an emerging leader in the development of vaccines that promote T-cell responses against viruses and cancers, has announced compelling data from two Phase I clinical trials of Flunisyn®, the Company’s lead vaccine programme which elicits potent immune responses against multiple strains of influenza-A virus.
The first Phase I trial showed that Flunisyn® generated statistically significant cell-mediated immune responses to the vaccine and was safe and well tolerated in vaccinated groups compared to placebo.
From both trials, the T-cell responses induced by Flunisyn® were able to recognise multiple strains of Influenza A.

Is general: Yes