Crucell and Aeras announces unique TB vaccine trials
Foundation has announced the initiation of a series of clinical
studies for a unique TB vaccine, which allows millions of doses to
be manufactured simultaneously while keeping costs relatively low.
This is of utmost importance particularly in the case of poverty-related diseases such as HIV, malaria and TB. In approaching vaccine development in this way, the hope is that more people can be treated more effectively as well as more cheaply.
The studies, which follow promising results for the vaccine obtained in animal studies, are scheduled to start in Europe, the US and Africa in the second quarter of 2006.
The vaccine uses a combination of adenovirus serotype-35 (Ad35) and Crucell's PER.C6 production technology. The technology is a cell line developed for the large-scale manufacture of biopharmaceutical products including vaccines.
The strengths of the PER.C6 technology lie in its safety profile, scalability and productivity under serum-free culture conditions.
"We developed a vector system that is stable over enough passages to allow for the production of a large number of vaccine doses," commented Crucell's chief scientific officer, Dr Jaap Goudsmit.
"It took us a substantial period of time to develop such a system for Ad35 vectors, particularly because our TB vaccine contains a combination of multiple antigens in a single vector," he added.
AdVac technology is a vaccine technology developed by Crucell and is considered to play an important role in the fight against emerging and re-emerging infectious diseases and in biodefence.
The technology supports the practice of inserting genetic material from the disease-causing virus or parasite into a 'vehicle' called a vector, which then delivers the immunogenic material directly to the immune system.
Most vectors are based on an adenovirus, such as the virus that causes the common cold. The AdVac technology is designed to manage the problem of pre-existing immunity in humans against the most commonly used recombinant vaccine vector, adenovirus serotype 5 (Ad5), without compromising large-scale production capabilities or the immunogenic properties of Ad5.
What is unique about the AdVac technology is that it is based on adenovirus vectors that do not regularly occur in the human population, such as Ad35.
In contrast to the AdVac vectors, antibodies to Ad5 are widespread among people of all ages and are known to lower the immune response to Ad5-based vaccines, thereby impairing the efficacy of these vaccines.
There is an urgent need for a fast, cost-effective way to contain tuberculosis in order to treat and control this highly contagious bacterium that infects one-third of the world's population,
The spread of TB has been most prevalent in developing countries where the rate of infection has been soaring. In the developing world, with poor infrastructure like roads and communications, even six months may be too long for the people located there.
Another factor has been the HIV pandemic, which has increased the problem of TB in addition to HIV itself.
