Tuberculosis vaccine
The vaccine candidate targeting Tuberculosis (TB) is a recombinant subunit vaccine based on our adjuvant IC31® in conjunction with antigens discovered by Statens Serum Institut (SSI).
An initial Phase I trial performed in healthy BCG-naïve volunteers obtained promising safety and immunogenicity data in March 2007. In the presence of IC31®, strong T-cell responses in humans were observed that further confirmed pre-clinical data. The study was conducted in the Netherlands and supported by the European Union-funded program “TB-VAC”.
Based on the promising data, a second Phase I clinical trial was initiated in December 2007. This study was conducted in latent TB-infected and BCG-vaccinated patients. The ongoing study intends to evaluate different tuberculosis antigens in combination with IC31®. It is conducted at Karolinska Institutet in Stockholm, Sweden, and funded by the Aeras Global Tuberculosis Vaccine Foundation and the EU.
In February 2008, sanofi-aventis and SSI entered into a partnership for further development of the vaccine candidate, aiming to make a new TB vaccine widely available in shortest possible time.
About Tuberculosis
According to the World Health Organization (WHO) an estimated one-third of the world’s population is infected. Most remain asymptomatic. However, each year, more than 9 million people worldwide develop active Tuberculosis (TB) and for about 1.7 million, the outcome is fatal. In addition, TB is the leading cause of death among people infected with HIV since each disease speeds the progress of the other.
The disease is caused by two different bacteria; Mycobacterium tuberculosis, the most common cause, and Mycobacterium bovis. It is transmitted from infected people with active TB by inhalation of aerosol droplets. Most commonly, it attacks the lungs as pulmonary TB but it can also affect the central nervous system, the lymphatic system, the circulatory system, the genitourinary system, bones, joints and even the skin.
Tuberculosis is most common in developing countries, particularly in Africa and Asia. Still, the rise in HIV infection and the neglect of TB control programs have enabled a resurgence of TB in the developed world as well. Even though the number of new cases per capita has been falling globally since 2003, population growth has increased the total number of infected cases, according to WHO.
Current treatment and prevention
Today the only available vaccine against TB, bacille Calmette-Guérin (BCG)-vaccine, is derived from an attenuated strain of Mycobacterium bovis. It has been used for more than 50 years; however, the protective efficacy of BCG for preventing pulmonary TB in adolescents and adults is variable, ranging from 0 to 80 percent. In addition, the world faces an increase in multidrug-resistant strains of Mycobacterium tuberculosis, highlighting the urgent need for an improved vaccine.
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Partners
- Statens Serum Institut (SSI)
- sanofi-aventis