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Vaccines are one of the best ways to prevent the world’s most common and dangerous infectious diseases. Because vaccines are not yet available for many significant infectious diseases and many bacterial pathogens are becoming resistant to antibiotics, there is a critical need for a new generation of efficient and safe vaccines.
Smart Vaccines – a new generation of vaccines
Intercell has specialized in the development of “smart vaccines”, which include only the essential ingredients and which stimulate both important elements of the human immune system: T-cells and B-cells.
Intercell’s first product on the market is a Japanese Encephalitis vaccine. The product is approved in the U.S. (FDA), Europe (European Commission), Canada (Health Canada) and Australia (TGA).
Japanese Encephalitis is a mosquito-borne infection which strikes 30,000 to 50,000 humans each year, causing about 15,000 deaths. The disease is most common in several developing countries in Asia and has expanded into new areas. Most affected are residents in rural areas, particularly children. In addition, the virus is a consistent threat to millions of international travelers and military personnel who visit these nations.
- Film: Production of our Japanese Encephalitis vaccine (5:14 Minutes)
Intercell is currently undertaking clinical studies of a novel, needle-free vaccine patch against Travelers’ Diarrhea (Phase III).
The most common cause of Travelers’ Diarrhea is bacterial contamination of food and water. Of the approximately 55 million travelers visiting endemic areas each year, about 20 million will develop Travelers’ Diarrhea. No existing vaccine broadly targets Travelers’ Diarrhea.
In addition, children and younger adults in developing countries in Asia, the Middle East, Africa, Central and South America are at particular risk. The World Health Organization (WHO) estimates that 350,000 children in endemic areas die every year due to infections of the bacteria causing Travelers’ Diarrhea.
Intercell’s vaccine against S. aureus is currently tested in Phase II/III (sequential design) clinical trials and is being developed in partnership with Merck & Co, Inc.
S. aureus, a bacterium, is the most common cause of hospital-acquired infections. Symptoms of S. aureus range from minor skin infections to serious or fatal infections of bone, inner organs or the blood. Today, many S. aureus bacteria are resistant to multiple antibiotics.
Intercell’s vaccine against the Pseudomonas bacterium is developed in-house and has shown promising results in multiple clinical studies.
Pseudomonas is the third-most-frequent cause of hospital-acquired infections. It causes disease in individuals with a suppressed immune system, including those suffering from severe burns, cancer or HIV. Pneumonia and infections of heart, central nerves, respiratory, skin and soft tissue are common. The bacterium is often resistant to antibiotics, which complicates the treatment.
Intercell is developing a treatment for Hepatitis C that stimulates the immune system to mount an attack on the viral infection. The approach, known as therapeutic vaccination, has shown promising results in Phase II clinical studies.
Hepatitis C is spread by direct contact with human blood. The disease can lead to chronic liver diseases, including cirrhosis (damages of normal liver tissue) and liver cancer. Worldwide, approximately 170 millions of people are chronic carriers of Hepatitis C, and 3 to 4 million are newly infected each year, according the World Health Organization. Currently, there is no vaccine and long-term treatment with marketed therapeutics is inefficient, costly and has substantial side effects.
Intercell is developing a Pandemic Influenza patch that is designed to enhance the immune response to existing injected Pandemic Influenza vaccines. If successful, the patch will expand the limited vaccine supplies by allowing lower doses of vaccine to be used.
The Vaccine Enhancement Patch (VEP) has generated positive data in ongoing clinical trials, demonstrating that – when used with an injected Pandemic Influenza vaccine – a single dose can confer protection. For the development and commercialization Intercell has an strategic alliance with GSK. The program is fully funded by the United States Department of Health and Human Services.
Pandemic Influenza is a global outbreak of Influenza that occurs when particularly virulent and easy-to-spread influenza strains emerge. During the 20th century, several major pandemics occurred, including the 1919 Spanish Influenza that killed as many as 40 million. The threat of a new global pandemic Influenza, such as the outbreak of the Asian, or bird, Influenza, accentuates the need for efficient vaccines that can be quickly administered.
Intercell’s vaccine against Seasonal Influenza is being developed in partnership with Novartis (Phase I ongoing). The vaccine combines our proprietary adjuvant (booster) IC31® with Novartis’ Influenza vaccine.
Influenza is a highly contagious viral disease. The virus attacks the respiratory tract and is transmitted from person to person by droplets. Usual symptoms include fever, headache, muscle pains and a runny nose. Though not usually deadly for most, the elderly are at particular risk of complications and death. As much as 15 percent of the world’s population suffers an Influenza infection each year, and 250,000 to 500,000 deaths are linked to Influenza each year, according to the World Health Organization. Vaccination rates with currently licensed vaccines remain below the goal of public health officials, and existing vaccines do not generate an optimal response in those with weakened immune systems.
Intercell’s novel vaccine against Tuberculosis is being developed in co-development with Denmark’s Statens Serums Institut and sanofi-aventis. Early data has been promising, and additional studies are on track.
Tuberculosis is caused by bacteria spread through the air and is one of the world’s most severe health problems. One-third of the world’s population is infected and the disease causes symptoms in about 5 to 10 percent of cases. A total of 1.5 million people die each year cause to the disease. In addition, Tuberculosis is the leading cause of death among people infected with HIV, since each disease speeds the progress of the other. Today’s licensed vaccine is given to newborns and provides excellent protection for 10 to 15 years, but a second boost does not provide sufficient protection, creating an unmet need for a vaccine in adolescents and adults.
Intercell is developing a novel vaccine targeting a majority of the subtypes of the Pneumococcus bacteria. The vaccine is intended primarily for children in developing countries, though we believe it will also fill a significant need for the elderly in developed countries. A Phase I clinical trial was initiated in 2009. The initial analysis of the Phase I data has indicated a good safety and tolerability of the vaccine candidate. The development of this vaccine candidate is supported by the U.S. non-profit organization PATH.
Streptococcus pneumoniae, or Pneumococcus, is the most common bacterial infection in both industrialized and developing countries. It causes middle ear infections (otitis media), bacteria in the blood (bacteraemia), lung inflammation (pneumonia), brain and cerebrospinal fever (meningitis) and systemic inflammatory response syndrome (sepsis). Very young children and the elderly are at highest risk. There are two vaccines on the market, recommended for different ages. Still, the vaccines are expensive and target only a limited number of the more than 90 different existent subtypes (serotypes) of the bacteria.
The vaccine against infections caused by Group A Streptococcus (GAS) is being developed in partnership with Merck & Co., Inc. and is based on antigens discovered Intercell. The vaccine is currently undergoing pre-clinical development.
GAS is a bacterium often found in the throat and on the skin of healthy individuals. Occasionally, it causes infections which range from mild throat or skin infections to more severe illnesses as rheumatic fever, destruction of muscles, fat and skin tissue or infections in inner organs. Sore throat in children is the most common form of GAS infection, which leads to 10 million doctor visits in the United States alone. Currently, GAS infections are treated with antibiotics. A new vaccine would then not only decrease the use and risk of antibiotics resistance but also reduce the large financial burden to the healthcare system.
A vaccine candidate targeting an undisclosed disease-causing microorganism is currently being developed by Intercell´s partner sanofi-aventis. The vaccine candidate has the potential to address an important unmet medical need in the field of infectious diseases. The vaccine is based on certain bacterial antigens, which have been identified by Intercell’s proprietary technology platform AIP® (Antigen Identification Program). In July 2005 sanofi-aventis exercised its option on exclusive worldwide commercial rights to the identified vaccine antigens.
Intercell is developing a prophylactic vaccine against Lyme Borreliosis (LB). The vaccine candidate is currently in pre-clinical development.
Lyme borreliosis is the most commonly reported tick borne-infection in Europe (about 85,000 cases annually), North America (between 20,000-25,000 cases registered each year) and Asia. (Source WHO and CDC). The most common sign of infection is a skin rash at the site of the tick bite. The bacteria can then disseminate and cause a variety of different manifestations including arthritis (damages to the joints of the body), carditis (heart inflammation) or neurological problems. There is today no available vaccine against LB and the disease is treated with long term application of antibiotics.
In addition to vaccines, we and our respective partners (Merck & Co., Inc. and Kyowa Hakko Kirin) are developing antibodies against infection diseases including Staphylococcus aureus, Pneumococcus, Group A Streptococcus and Group B Streptococcus.

