The Phase I/IIa trial will assess the safety, reactogenicity and immunogenicity of the vaccine regimen. Credit: Marco Verch.

UK-based Vaccitech has started treating patients with influenza A vaccine MVA-NP+M1 (VTP-100) in a Phase IIb clinical trial.

Located in Antwerp, Belgium, the trial will recruit a total of 155 individuals, which will be administered with either VTP-100 or placebo.

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Designed to prevent both seasonal influenza and pandemics, VTP-100 triggers enhanced immune protection against all influenza A strains. It uses a replication-deficient pox viral vector called MVA to produce a strong immune response against Matrix 1 (M1) and Nucleoprotein (NP) influenza antigens.

Dubbed Flu 010, the Phase IIb trial is intended to evaluate VTP-100’s protective capabilities as a standalone vaccine for use in a future pandemic or pre-pandemic influenza.

Of the total participants, 134 will receive the A/Belgium/4217/2015 (H3N2) influenza virus strain.

Vaccitech expects study data to be available early next year.

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The company noted that its Australian subsidiary has completed vaccination of 2,200 participants in a double-blind, randomised, placebo-controlled Flu 009 Phase IIb field trial being conducted in the country.

This trial will assess VTP-100’s additive protective efficacy against influenza-like illness when given in adjunction with existing licenced quadrivalent influenza seasonal vaccines (QIV).

Outpatients that received standard-of-care QIV earlier in the influenza season were enrolled at nine sites across Australia. The trial will investigate if VTP-100 + QIV could provide better efficacy over QIV alone.

Interim results from the trial are expected early next year. Based on the findings, the company intends to continue the study for a second season and enrol up to 6,000 participants overall in Australia.

Vaccitech CEO Tom Evans said: “We expect positive data to support the positioning of VTP-100 as a vaccine that can reduce the burden of influenza, both as a pre-pandemic intervention and as an add-on to a seasonal vaccine, especially in high-risk individuals.”