The UNISEC consortium has started a clinical trial study for one of its Universal Influenza Vaccines
16 October 2016, RUG Groningen, The Netherlands: The European consortium, UNISEC, has started the next phase in its search for an Universal Influenza Vaccine. Founded and coordinated from Groningen, The Netherlands, it is hereby one of the first parties, and probably the most advanced one on the globe, to find an answer against the dangerous threat to human population by a serious outbreak of pandemic influenza.
Influenza is a serious and expensive threat to the human population. The current strategy to prevent influenza-associated health risks is an annual vaccination of risk populations. Yet, current vaccines need to be adjusted each year and even then it is not guaranteed that they will match the circulating virus. Unfortunately, current vaccines are not effective against newly emerging influenza virus strains as demonstrated during the Mexican Flu Pandemic in 2009. Universal influenza vaccines, effective against a broad spectrum of influenza virus strains, are thus urgently needed. Such vaccines are based on conserved constituents of the virus and should raise humoral as well as cellular immunity that protect against influenza disease.
UNISEC* is a European consortium www.unisecconsortium.eu consisting of 3 academic partners, 5 National Health Institutes and 3 companies, all with leading expertise in influenza vaccine research and development. In addition, UNISEC has access to a network of clinical trial centers. UNISEC develops and evaluates a number of vaccine concepts in order to identify, develop and clinically test the most promising leads for a universal influenza vaccine, which must demonstrate adequate protection, and be technically suitable for development to a marketable product.
UNISEC is launching its first clinical study in October 2015. This phase IIb trial is a multicenter, randomized, double-blind, active-controlled study conducted under the auspices of the UNISEC consortium. The aim of the trial is to assess the safety and immunogenicity of the universal influenza vaccine candidate Multimeric-001 (developed by BiondVax Pharmaceuticals ltd (Israel). The trial will include 222 healthy adults aged 18-60 years, a group representing the target population for receiving vaccines when a pandemic outbreak occurs.
The trial is being conducted at the St. Istvan and St. Laszlo Hospital in Budapest, Hungary as well as additional satellite sites in the country. Recruitment of participants for the trial has started, and results are expected in the second half of 2016.
This clinical study will examine the benefits of priming with BiondVax’s universal flu vaccine prior to immunization with a bird flu prototype influenza vaccine (FluArt, Hungary). This new approach will enable public health authorities to be proactive and prepared in advance of any flu pandemic outbreak, by building a national stockpile of the universal flu vaccine. Such a stockpile allows vaccinations to start immediately upon any pandemic outbreak, compared to the current-day situation, in which there will be a delay of approximately 6 months due to the manufacture of the pandemic strain-specific vaccine.
The current trial is led by Prof. Dr. Eelko Hak, Trial Coordinator on behalf of the UNISEC consortium from the University of Groningen, The Netherlands and Dr. Zsofia Meszner, General Director of the National Institute of Child Health from St. Istvan and St. Laszlo Hospital (Hungary) as Principle Investigator and Dr. Dora Mathiazs the Strategic Director of the hospital. BiondVax, as well as other partners of the UNISEC consortium including the Robert Koch Institute in Berlin and the National Center of Epidemiology in Budapest, will be involved in the immunogenicity testing of the cellular and humoral responses.
Additional phase IIb clinical study with another universal influenza vaccine candidate, developed by the UK-based company SEEK (PepTcell Ltd), also member of the UNISEC consortium, is scheduled for 2016.
For further information please contact:
Prof. Erik Frijling (coordinator UNISEC consortium)
Tel: +31 (0)503633285Fax: +31 (0)503632500E-mail: firstname.lastname@example.org
Dr. Limor Chen (BiondVax Pharmaceuticals ltd)
Tel: +972 (0)89302529
Prof. John Oxford (dissemination)
Tel : +44 (0)7831 165 847
Email : email@example.com
This project has received funding from the European Union’s Seventh Framework Program for research, technological development and demonstration under grant agreement no. 602012.
*Universal Influenza Vaccine Consortium UNISEC
University of Groningen RUG The Netherlands:
Academic Medical Center Groningen UMCG The Netherlands.
SEEK (PepTcell Ltd) United Kingdom
BiondVax Pharmaceuticals Ltd Israel
hVIVO Services Ltd (formerly Retroscreen Virology Ltd) United Kingdom
National Institute for Biological Standards and Control NIBSC United Kingdom
Statens Serum Institute SSI Denmark
National Center of Epidemiology NCE Hungary
The Norwegian Institute of Public Health NIPH Norway
Robert Koch Institute RKI Germany