FluGEM®
Influenza is caused by a virus that attacks mainly the upper respiratory tract – the nose, throat and bronchi and rarely also the lungs. In the very young, the elderly and people suffering from medical conditions such as lung diseases, diabetes, cancer, kidney or heart problems, influenza poses a serious risk. In these people, the infection may lead to severe complications of underlying diseases, pneumonia and death. In annual influenza epidemics 5-15% of the population are affected with upper respiratory tract infections. Hospitalization and deaths mainly occur in high-risk groups (elderly, chronically ill). These annual epidemics are thought to result in between three and five million cases of severe illness and between 250,000 and 500,000 deaths every year around the world. Most deaths currently associated with influenza in industrialized countries occur among the elderly over 65 years of age. In addition, influenza infections impose a considerable economic burden in the form of hospital and other health care costs and lost productivity. For example, in the USA recent estimates put the cost of influenza epidemics to the economy at US$ 71-167 billion per year.
FluGEM® is a new seasonal influenza vaccine candidate that can be administered intranasally. It is based on the validated bacterium-like-particle (BLP) based Mimopath® technology and the traditional egg- or cell-based inactivated trivalent influenza vaccines (TIV). In preclinical studies intranasal FluGEM® provided both robust local and systemic immune responses which resulted in superior and longer lasting protection in animal challenge models compared to a intramuscularly administered split virion benchmark vaccine. Preclinical toxicity studies show that intranasal FluGEM® is also very well tolerated. An adaptive clinical study in healthy adults and elderly using Mucosis intranasal FluGEM® vaccine began mid-2011. FluGEM® advantages:
- Allows for needle free administration;
- Both robust local and systemic immune responses;
- Superior protection.
Saluja V, Amorij JP, Roosmalen ML van, Leenhouts K, Huckriede A, Hinrichs WL, Frijlink HW. Intranasal delivery of influenza subunit vaccine formulated with GEM particles as an adjuvant. AAPS J. 2010; 12(2):109-16.
Saluja V, Visser MR, Veer W ter, Roosmalen ML van, Leenhouts K, Hinrichs WLJ, Huckriede A, Frijlink HW. Influenza antigen-sparing by immune stimulation with Gram-positive enhancer matrix (GEM) particles. Vaccine 2010; 28:7963-7969.
Saluja V, Visser MR, Roosmalen ML van, Leenhouts K, Huckriede A, Hinrichs WLJ, Frijlink HW. Gastro-intestinal delivery of influenza subunit vaccine formulation adjuvanted with Gram-positive Enhancer Matrix (GEM) particles. Eur. J. Pharm. Biopharm. 2010; 76:470-474.