VaxInnate reports positive results from Phase I flu vaccine study

VaxInnate, a biotechnology company, has reported positive results from the Phase I study of VAX125, the company’s investigational hemagglutinin-flagellin flu vaccine. The flu vaccine was found to be safe and immunogenic in the study.

The new data support the potential of VAX125 to meet global vaccination needs, something currently not possible using conventional egg- or cell-based vaccines that require months to produce. VAX125 is the H1 component of what would ultimately be a trivalent seasonal flu vaccine, the company said.

Conducted in two parts, the Phase I study was designed both to assess the safety and immunogenicity a patient’s ability to make an immune response of different doses of VAX 125 and to select the optimal dose for use in a trivalent vaccine.

Part one was an open-label, escalating, dose-ranging Phase I study that assessed the safety and immunogenicity of seven doses (0.1, 0.3, one, two, three, five and eight micrograms) of VAX125 in 56 healthy adults aged 18-49.

Each of the seven VAX125 dosage levels was given as a single intramuscular dose to eight subjects.

Clinical and laboratory safety assessments took place one and seven days after immunization; immune response to VAX125 was assessed 0, seven, 14 and 28 days after immunization. All seven doses were safe and well tolerated, with one subject in the three micrograms dose group experiencing flu-like symptoms.

Part two was a randomized, placebo-controlled, blinded study designed to assess the safety and immunogenicity of the one micrograms and two micrograms doses and to select the optimal dose for a trivalent vaccine.

Approximately 48 healthy adults aged 18-49 were randomized into three groups to receive a single intramuscular dose of one micrograms (16 subjects) and two micrograms (16 subjects) compared to placebo (16 subjects). Clinical and laboratory safety assessments took place 0, 14 and 28 days postimmunization. Both doses were safe and well tolerated.

Given the antibody responses and the absence of significant adverse reactions, VaxInnate intends to continue development and clinical evaluation of the vaccine candidate for use in a trivalent vaccine formulation.

David Taylor, chief medical officer of VaxInnate, said: VaxInnate’s hemagglutinin-flagellin vaccine candidate for seasonal flu has passed a critical initial test. We’re encouraged by these data, which show that VAX125 is safe and elicits a potent immune response at sub-microgram doses. That’s particularly impressive when you consider that the dose of conventional flu vaccines in use today is 15 micrograms for each component.