Bangalore, Feb 24, 2010: Tuberculosis or TB is the oldest disease known to science. Today, it is one of the biggest killers affecting almost two billion people. Far from being a disease of the past, around one-third of the earth’s population is infected, resulting in over nine million new cases and close to two million deaths annually.

About one-third of the world’s population is infected with Mycobacterium tuberculosis. Only about one in 10 infected people develop clinical symptoms within one to two years. In most other individuals, a latent infection develops, with an approximately 10 percent risk of developing the disease in future. People with HIV run a much higher risk; they are twenty-times more likely to develop the symptoms once they are infected.

With new infections occurring at a rate of one person per second, millions of people develop TB symptoms every year. In 2007, 9.27 million new cases were reported, up from 8.3 million in 2000 and 6.6 million in 1990. Over half of these cases are in Asia, predominantly China, India and Indonesia. Africa is also highly affected, with about one-third of new cases. Particularly, South Africa and Nigeria have many victims. In 2007, around 1,750,000 people died from tuberculosis. One in four deaths was HIV-related.

In 2007, Hannu Laang and Ole Olesen of the European Commission were the first to suggest the establishment of a separate entity to fund research for new vaccines to conquer tuberculosis. Less than a year later, on March 5, 2008, Tuberculosis Vaccine Initiative (TBVI) was established, a European-based foundation facilitating development of safer and more effective vaccines against tuberculosis.

TBVI is based in the Dutch city of Lelystad and is headed by Dr Jelle Thole, its director since launch. Dr Thole in an interview with BioSpectrum shares his thoughts on various issues such as TBVI’s initiatives, funding and development partners.

What are the major initiatives taken by TBVI to curb TB in the Asian countries?

TBVI is developing vaccines that are useful to people all over the world and are not focusing on specific vaccines for Asia. There is no reason to have specific vaccine for Asia because the TB-related issues are common in nature. The current live vaccine that we use is Bacillus Calmette-Guérin (BCG) and this protects children up to five years from meningitis. What we are trying to do now is to develop vaccines that boost the second vaccination of BCG and improve the performance in adult population.

We are also supporting a number of partnerships that develop these kinds of vaccines. The other type of vaccines that we are developing is the BCG replacement vaccine that will be used in children. BCG should offer long-term protection, however, it is entirely safe when it is used in HIV positive population. Initially, these vaccines will be tested in Africa and Asia before being used globally. For developing vaccines, we are working with organizations in South Korea—International Vaccines Institute, Seoul, and Young Sai University, Seoul. We are planning to expand our presence in Asia.

Eradication of TB has been just next to impossible. What makes TB so difficult to tackle?

TB has been around for thousands of years. The TB bacterium has evolved with the human host since a long time and it has continuously adapted to the human body. The TB bacterium has been very clever in resisting and adapting to the human host. It also has to do with different physiological forms of the bacterium. The bacterium can remain dormant in the human body evading and cheating the immune system. Almost two billion people, onethird of humanity is affected and they do not know if they are carriers of the disease unless their immunity weakens. In our second generation vaccines, we are developing vaccines that will have boosting properties.

Could you give an overview of TBVI’s partnerships and its effectiveness in finding cure for TB?

We do not have such product development partnerships (PDPs) as yet. We are working according to a different model where we leave ownership and responsibility with the partners we support.

Who are your major partners and how are those partnerships fulfilling your needs?

We work with over 40 research partners in Europe, Africa, Asia and South-America and we have a variety of joint projects with them. We are supported by European Commission, Bill and Melinda Gates Foundation, FIT-BIOTECH and Institute Merieux. We aim for a portfolio of five programs with a budget of $286 million (€200 million) for the coming 10 years; in our first year of existence in 2009 we have raised about $21.45 million (€15 million).

How do you operate internationally?

European Commission has a big project called the International project and in this project 35 partners work together. They are bound by a contract and have specific deliverables deadlines. Some of them work together and others work together in specific areas. Everybody, each year or twice a year gets exposed to the consortium and gets to know what is happening in the consortium. This brings them together and they can network with each others.

Has there been a decline or increase in the number of TB cases globally?

The TB Report is always two years late, so the report released in 2009 deals with cases of 2007 and the one coming in 2010 will be based on 2008 results. In 2007, there has been a slight decline of one percent in the number of new instances globally. This is very important because this might be a turning point because there has been an increase of 10 percent in the last 10 years. However, we need to wait and watch how much the infections decrease. A lot of countries have adopted DOTS strategy and they are treating positive cases. The partnership aims to detect 70 percent of these cases, treat 85 percent of them and we reach that target.