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Medical monitor support and advice for FLU-v phase IIb study for influenza

Medical monitor support and advice for FLU-v phase IIb study for influenza
February 18, 2021 SueCarr

Each year, influenza affects up to 5 million people worldwide and leads to an estimated 650,000 deaths. Currently, the most effective available treatment is an annual vaccination with inactivated and attenuated influenza virus.

With the annual challenge of new strains, the efficacy of vaccines can be affected, and vaccine availability is often limited.

There are a number of projects in the pipeline looking to develop an efficacious universal influenza vaccine. FLU-v is one of these and is a broad-spectrum influenza vaccine that includes antibodies and cell-mediated immunity.

Boyds’ Dr Bryan Murray was the Medical Monitor on the Netherlands-based trial and provided support, oversight, and advice. The study was a randomised, double-blind, placebo-controlled, single-centre phase IIb clinical trial and involved 175 healthy adults aged between 18 and 60.

The aim of the trial was to compare the safety, immunogenicity, and exploratory efficacy of different formulations and dosing regimens of FLU-v versus placebo.

The study concluded that the adjuvanted FLU-v is immunogenic and merits phase III development to explore efficacy.

Commenting on the study, Dr Murray said: “There are a number of projects underway looking for a universal vaccine. The results of this study show real promise towards the discovery of a universal vaccine for the protection against influenza infection.”

To read the full details of the study and its results, click here.

Boyds provides medical monitoring support in relation to patient eligibility, adverse event advice and guidance and overall pharmacovigilance activities. Boyds is also able to provide CRA and clinical site management support if required. Find out more here.