Tuberculosis Vaccine Initiative
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TuBerculosis Vaccine Initiative P.O. Box 65 8200 AB Lelystad The Netherlands T +31 (0) 320 238960 F +31 (0) 320 238050 E [email protected] Chamber of Commerce 09180367 www.tbvi.eu ANNUAL REPORT 2008 Making TB a disease of the past ANNUAL REPORT 2008 CONTENTS Foreword 5 Making TB a disease of the past Tuberculosis 7 One death every eighteen seconds TBVI 11 Working together to conquer TB TB R&D in Europe 15 Greater investment in research Fundraising & Advocacy 19 Opening doors and finding sympathetic ears TBVI in action 23 Bridging the gap Organization 27 Partners 33 Donors 35 Financial Report 37 FOREWORD Making TB a disease of the past In the summer of 2007, Hannu Laang and Ole Olesen ten years. These resources will be used to stimulate scientific of the European Commission were the first to suggest discovery, to facilitate early clinical development of new the establishment of a separate entity to fund research vaccines, and to find biomarkers that indicate the potential for new vaccines to conquer tuberculosis. Less than success of vaccine candidates at an early stage. TBVI a year later, on 5 March 2008, Tuberculosis Vaccine aims to link scientific discovery and preclinical development Initiative or TBVI was established, a European based with industrial product and clinical development; to bridge foundation facilitating development of safer and more the gap between research and development. effective vaccines against tuberculosis. TBVI’s first year was mainly directed at establishing rela- In the years preceding the establishment of TBVI, thanks tions with governments, NGOs and industry. At the time of to EU funding and the combined efforts of the TBVAC writing this foreword, the first donations are coming in. We partners we had made excellent progress (TBVAC is an are extremely happy with the support of the EC and with integrated EU project). However, much work remained to the recent approval of the NEWTBVAC project to succeed be done and far more funding would be required for deve- TBVAC for the next four years. We’re delighted with the loping new vaccines. The STOP-TB partnership estimated support of the Bill and Melinda Gates Foundation, which a global requirement of 1.5 billion dollars for 2006-2015. enables us to conduct our advocacy and fundraising ac- To bridge the gap, we had to find other donors besides tivities for the next three years. Finally, we have secured European Union institutions. With financial support from the support of our first industrial donor, FIT Biotech. governments, non-governmental organizations and private industry, we could finance more scientific discovery, re- In the coming years, TBVI strives to support research and search and development. development in research centers all over Europe. Financially and practically. If we can generate sufficient resources TBVI was established using the infrastructure we laid and successfully join scientific research and industry, we down for TBVAC, and with assistance from the EU and might see the dawn of an era in which TB really is a dis- Wageningen University & Research Centre among others. ease of the past. TBVI consists of broadly the same partners that joined forces for TBVAC. The main goals of TBVI are to continue Jelle Thole, Director TBVI the international consortium of research institutes and to generate additional funding of € 200 million over the next 5 TUBERCULOSIS One death every eighteen seconds Far from being a disease of the past, tuberculosis cent risk of developing the disease in later life. People claims millions of victims each year. Around one third with HIV run a much higher risk; they are twenty times of the earth’s population is infected, resulting in over more likely to develop the symptoms once they are 9 million new cases and close to 2 million deaths an- infected. nually. With new infections occurring at a rate of one per second, Tuberculosis, or TB, is a common and often deadly infec- millions of people develop TB symptoms every year. In tious disease. It is caused by mycobacteria, mostly Myco- 2007, there were 9.27 million new cases, up from 8.3 million bacterium tuberculosis in humans. Tuberculosis spreads in 2000 and 6.6 million in 1990. Over half these cases are through the air when individuals who have the disease in Asia, predominantly China, India and Indonesia. Africa cough, sneeze or spit. A single sneeze can release up to is also heavily affected, with about a third of new cases. 40,000 droplets, each of which can transmit the disease. Particularly South Africa and Nigeria count many victims. In 2007, around 1,750,000 people died from tuberculosis. Tuberculosis usually attacks the lungs, but can also affect One in four deaths is HIV-related. other parts of the body, such as the lymphatic system, the central nervous system and the circulatory system. The Multiple drugs treatment classic symptoms of pulmonary TB are a chronic cough TB is treated with (a combination of) antibiotics to kill the with blood-tinged sputum, chest pain, fever and weight bacteria. However, whereas a treatment of one or two loss. Infection of other organs causes a wide range of weeks suffices for many other diseases, TB requires symptoms. Infection usually starts in the lungs. The bacteria much longer periods of treatment, up to a year. The best multiply and spread through the body through the results are obtained with DOTS, directly observed treatment, lymphatic system and the bloodstream. short-course. This involves observed treatment with four drugs for two months, followed by treatment with two One in three infected drugs for another four months. However, if the treatment About one third of the world’s population is infected with is prematurely ended or if the patient does not adhere to Mycobacterium tuberculosis. However, most will not get the prescribed regimen, the bacteria might become drug- ill. Only about one in ten infected people will develop clinical resistant. Drug-resistant TB poses an increasing problem. symptoms within one to two years. In most other individuals, About 5 per cent of the new cases of prevalent TB are a latent infection develops, with an approximately 10 per multidrug-resistant, that is, resistant to front-line DOTS 7 A disease of all ages drugs. Fifty-five countries have reported cases of exten- facing TB. The main goal is to dramatically reduce the Tuberculosis has been around since antiquity. Skeletal sively drug-resistant TB (XDR-TB). XDR-TB strains are global burden of tuberculosis by 2015 by ensuring that all remains have shown that prehistoric man suffered from resistant to both front line and second line anti-TB drugs. TB patients, including for example, those co-infected with TB, and tubercular decay has been found in the spines of HIV and those with drug-resistant TB, benefit from universal mummies from 3000 to 2400 BC. Hippocrates reported Control of tuberculosis is based upon two main pillars. access to high-quality diagnosis and patient-centered around 460 BC that tuberculosis was the most widespread Firstly, detection of individuals with TB in their sputum and treatment. The strategy also supports the development of disease of his time. subsequent treatment using DOTS. Secondly, children new and effective tools to prevent, detect and treat TB. are vaccinated with BCG to protect them against TB. BCG The Stop TB Strategy underpins the Stop TB Partnership’s The study of tuberculosis dates back to ‘The Canon of was developed between 1905 and 1921 at the Pasteur Global Plan to Stop TB 2006-2015. Medicine’ written by Ibn Sina in the 11th century. He iden- Institute in France. A century later, it is still the only vaccine tified pulmonary tuberculosis as a contagious disease and available. In children, the vaccine is highly effective was the first to suggest that it could spread through contact against disseminated TB and TB meningitis. However, BCG with soil and water. On 24 March 1882, Robert Koch is much less effective against pulmonary TB, especially in identified and described the bacillus causing tuberculosis: adolescents and adults. Furthermore, the vaccine may mycobacterium tuberculosis. In 1905, Mr. Koch received seriously harm children who are infected with HIV. the Nobel Prize for his discovery. Stop TB Partnership In 1908, French immunologists Camille Guérin and Albert In 1988, the Stop TB Partnership was established to combat Calmette at the Institut Pasteur started developing a vac- TB. Its aim is to halve the global burden of TB disease cine against TB. It would be called BCG (Bacille Calmette- relative to 1990 levels by 2015 and to eliminate TB as a Guérin). The BCG vaccine was first used in humans in However, in the developing world, many people still public health issue by 2050. The Partnership comprises France in 1921, but is was not until after World War II that fell victim to TB each year. The worldwide occurrence international organizations, countries, donors from the BCG was widely accepted and used, reducing the occur- of TB increased again from 124 per 100,000 (1990) to public and private sectors, governmental and nongovern- rence of TB considerably. 142 per 100,000 (2004). Since then, it has decreased mental organizations and individuals who have expressed slowly to 139 per 100,000. In Asia and Africa especially, an interest in working together to achieve this goal. The disease was further constrained by a steady improve- more than 4000 people die from the disease each day. ment in hygiene, sanitation, diagnosis and treatment. In HIV co-infection and the increasing incidence of drug- The World Health Organization (WHO) has developed a Europe, the number of deaths from TB steadily declined. resistant strains challenge current control programs.