US-based biopharmaceutical company FluGen has begun the first Phase I clinical trial of H3N2 RedeeFlu universal vaccine for influenza.
The RedeeFlu vaccines are new M2-deleted single replication (M2SR) viruses that rapidly issues antibody and cellular immune responses similar to that of wild type influenza, but without producing an infectious virus.
The randomised, blinded, dose-ranging Phase I trial has enrolled 96 healthy adult subjects between 18 and 49 years of age.
The trial has been designed to determine the safety of the vaccine, as well as evaluating both the antibody and T-cell responses generated by the vaccine.
FluGen president and CEO Paul Radspinner said: "The initiation of this first in man study is an important milestone achieved through the research and development efforts of the FluGen team and our collaborators.
“We believe that RedeeFlu could be the first influenza vaccine to show robust protection from drifted or mismatched flu strains.”
Influenza (flu) is a contagious respiratory disease triggered by influenza viruses transmitted from person to person via droplets and small particles produced when infected people cough or sneeze.
Symptoms of the disease are a sudden onset of high fever, aching muscles, headache and severe malaise, non-productive cough, sore throat and rhinitis.
In previous multiple preclinical models, RedeeFlu vaccines have demonstrated protection against both drifted and completely mismatched strains of influenza when compared with other live or inactivated influenza vaccine technologies.