Acambis plc, a leading vaccines company, has initiated a phase 1 clinical trial of its universal influenza vaccine candidate, ACAM-FLU-A.
ACAM-FLU-A is designed to be a universal vaccine candidate targeting all 'A' strains of the influenza virus. As such, it has the potential to be both a universal pandemic influenza vaccine and part of a universal seasonal vaccine. Historically, influenza pandemics have been caused by 'A' strains of the virus while seasonal vaccines target both 'A' and 'B' strains of the virus.
The phase 1 trial is: A randomised, double-blind, placebo-controlled, multi-centre trial in the US; Investigating ACAM-FLU-A's safety, tolerability and ability to generate an immune response. Being conducted in up to 80 healthy subjects aged between 18 and 40 years; and assessing two adjuvants or "immune stimulants' to determine whether they improve the effect of the vaccine on the immune system.
ACAM-FLU-A is the first vaccine candidate being developed under Acambis' influenza programme. It is a recombinant vaccine that uses a hepatitis B core protein to deliver M2e, the extra-cellular domain of the ion channel protein M2. Being highly conserved, M2e is intended to elicit immune responses to all influenza 'A' strains.
Acambis is using multiple approaches to develop innovative influenza vaccines. In addition to ACAM-FLU-A, its programme includes activities to identify an equivalent conserved region within the influenza virus 'B' strains in order to generate a universal vaccine candidate protective against all the strains that cause the high annual morbidity and mortality in humans. Acambis is also exploring recombinant neuraminidase- and haemagglutinin-based vaccines and their delivery using proprietary platform technologies to develop vaccine candidates superior to existing seasonal influenza vaccines.
Dr Michael Watson, Acambis' executive vice president, research & development, commented: "As a universal vaccine, ACAM-FLU-A can potentially overcome many of the drawbacks of existing influenza vaccines. By removing the need to re-engineer the vaccine each time the virus mutates, a universal vaccine can be manufactured and used at any time of year. It could be stockpiled in advance of a pandemic or potentially used routinely to ensure population protection against future pandemics. This trial is designed to prove that the vaccine generates an immune response as well as to give us safety data. We look forward to seeing the results around the end of this year.'
"With the market for influenza vaccines projected to rise to $4bn by 2010(1), this is a very attractive opportunity. Our universal vaccine approach is highly innovative and gives us a strong competitive position in the influenza vaccine market," said, Ian Garland, chief executive officer of Acambis.
Acambis' vaccine candidate was developed using technology licensed from VIB that was invented by Walter Fiers, Emeritus Professor of the VIB Department for Molecular Biomedical Research at the University of Ghent, Belgium.
As part of Acambis' plans to test the effect of various adjuvants on the safety and immunogenicity of ACAM-FLU-A, two adjuvants are being tested in this Phase 1 trial: aluminium hydroxide, which is widely used in licensed vaccines; and QS-21 Stimulon adjuvant, which is an investigational adjuvant provided under a licence and option agreement with Antigenics Inc.
Acambis is a vaccine company developing novel vaccines that target unmet medical needs or offer significant improvements over existing products. ChimeriVax-JE, Acambis' most advanced product in its non-bio-defence pipeline, has to date shown an excellent safety and efficacy profile following pivotal Phase 3 trials.