Pseudomonas vaccine
Intercell’s prophylactic vaccine against Pseudomonas infections has shown safety and first hints for efficacy in Phase II studies in patients with 2nd- and 3rd-degree burns. The vaccine candidate is currently being tested in a next extensive Phase II clinical trial. The interim analysis from 225 out of 400 total patients to be vaccinated in this study has shown good safety and tolerability of the vaccine. In addition, robust immunogenicity by antibody induction which were assessed by standard and avidity IgG ELISA and functional opsonization assays could be shown.
Our vaccine candidate targeting Pseudomonas infections is being developed in-house and is based on antigens derived from two outer-membrane proteins from Pseudomonas aeruginosa.
In six previous Phase I and II clinical trials, the vaccine candidate has shown an excellent safety and tolerability profile. The vaccine has been found to be highly immunogenic at all dose levels tested and has generated strong humoral responses even in patients with 2nd- and 3rd-degree burns, who have a high risk of immune suppression. No critical safety findings were made.
The current Phase II study aims to investigate immunogenicity and safety in intensive care patients. About 400 patients will be enrolled in more than 50 intensive care units in 11 countries in Europe and Latin America.
A major cause of nosocomial infections
Pseudomonas aeruginosa (Pseudomonas) is the second-leading cause of nosocomial infections, which are mainly acquired in intensive care units, and affects primarily patients who require mechanical ventilation. Infections of the heart, central nervous system, respiratory system, skin and soft tissue are common. The free-living and tolerant gram-negative bacillus rarely causes infections in healthy persons but is a significant threat to patients suffering from cystic fibrosis or with a suppressed immune defense, particularly patients suffering from severe burns, cancer or HIV. Invasive infections may also occur when intact skin or mucous membrane is disrupted by insertion of medical devices as urinary or intravascular catheters.
Hospital-acquired infections are one of the major causes of death and serious illness worldwide, resulting in an annual cost burden of more than USD 20 billion in the developed world. In the United States and Europe about 4 million patients become infected annually resulting in 200,000 deaths per year. The incidence of nosocomial infections is steadily increasing due to increasing medical interventions and antibiotic resistance.
Current treatment and prevention
Pseudomonas aeruginosa is intrinsically resistant to many antibiotics at concentrations achievable in vivo. In the treatment of pulmonary infection, antibiotics need to penetrate to the bronchial epithelium and secretions. However, in patients with cystic fibrosis and bronchiectasis, penetration may be reduced due to thickening and scarring of the bronchial wall.
Despite the use of newer broad-spectrum anti-Pseudomonas agents including cephalosporins, fluoroquinolones, and carbapenems, Pseudomonas aeruginosa infection remains a major cause of morbidity and mortality in hospitals. A variety of new approaches are under study including inhaled antibiotic therapy, growth factors and vaccines. Passive immunotherapeutic approaches using human monoclonal antibodies are also being investigated.
Currently there is no licensed vaccine available to prevent infection with Pseudomonas aeruginosa.
Latest News
Intercell provides update on ongoing Phase II vaccine studies
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