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draadje tuberculose

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TB Vaccine Critical, But Money Tight
BERLIN - An important tuberculosis vaccine trial among HIV-positive participants in Klerksdorp has been paused this year due to funding constraints as governments and donors pull back in the face of struggling economies.
Peg Willingham, Senior Director External Affairs at Aeras told journalists this week that less money was being channeled towards the development of a TB vaccine and that some governments had "taken time off".
"It will still take time to develop a vaccine, even if we had all the money in the world. The science is difficult," Willingham added.
There was however, some good news with the Netherlands Ministry of Foreign Affairs renewing its funding to Aeras with a pledge of an additional 11,7-million Euros over four years.
She said the Klerksdorp trial would resume next year. The Aeras Global TB Vaccine Foundation is a non-profit development partnership developing new TB vaccines and ensuring they are distributed to those who need it.
Speaking on the eve of the 41st Union World Conference on Lung Health, Willingham said they were not in competition with other diseases also in need of a vaccine, but that "money goes to things that are politically popular".
Aeras has set as a goal the development of a vaccine that can be given to all ages as well as those living with HIV and drug-resistant TB. There are currently 9 candidate vaccines in clinical trials with several being tested at South Africa sites. South Africa is also being considered as a site to manufacture a TB vaccine once a successful product has been developed.
"We don't want a vaccine that's too expensive, so we won't pursue it. When it comes to TB, customers are people who can't pay," said Willingham.
The only TB vaccine currently available, the Bacille Calmette Guerin (BCG) gives limited and unreliable protection and does not protect against pulmonary TB which affects 75% of those infected. In South Africa, BCG is given to infants a couple of hours after birth.
Researchers presenting at The Union conference have called for HIV positive infants to be placed on antiretrovirals as soon as they are diagnosed. There is agreement that currently the BCG vaccine is not safe in HIV-infected infants, but that this may change as ARVs become more widely available.
Because it is a live vaccine, it can cause "disseminated BCG disease," a type of whole-body bacterial infection that is fatal in more than 70 percent of cases.
The World Health Organisation (WHO) recommends that use of the BCG vaccine be delayed until infants can be tested for HIV.
According to WHO statistics 1,7-million people died from TB in 2009, including 380 000 with HIV. This equates to 4 700 deaths a day.
There were 9,4-million new TB cases in 2009.
allafrica.com/stories/201011140006.html

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A phase II clinical trial of AERAS-402/Crucell Ad35 in adults infected with HIV was started in April 2010. HIV patients are at high risk of TB co-infection and the two diseases are an especially deadly combination, so the results of this safety and efficacy trial will be eagerly awaited. The study is being conducted by the Aurum Institute in Klerksdorp, South Africa.
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Even in de blender….

Aeras Awarded €11.7 Million Grant from Dutch Government www.aeras.org/newscenter/news-detail....
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BERLIN - An important tuberculosis vaccine trial among HIV-positive participants in Klerksdorp has been paused this year due to funding constraints as governments and donors pull back in the face of struggling economies.
allafrica.com/stories/201011140006.html
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clinicaltrials.gov/ct2/show/NCT01017536
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Via de deurmat: January
Aeras Newsletter

Phase II Clinical Trial in Kenya Advances

Sixty-four infants have been enrolled, to date, in a Phase II tuberculosis vaccine clinical trial in the Siaya District, Nyanza Province of Western Kenya. The candidate vaccine is AERAS-402/Crucell Ad35, and is designed as a booster to the currently available TB vaccine. The Kenya study is led by KEMRI/CDC, a joint research project of the Kenya Medical Research Institute and the Centers for Disease Control and Prevention.

The trial in Kenya is the first phase of a multi-center clinical trial co-sponsored by Aeras and is designed to evaluate dosing regimens for the second phase of the trial. The second phase is designed to evaluate the efficacy of the candidate vaccine and includes expansion of the study into additional African research locations. Significant support for this Phase II trial comes from the European and Developing Country Clinical Trials Partnership (EDCTP) through a consortium of African research institutes, which includes KEMRI/CDC.

Professor Charles Mgone, the EDCTP Executive Director, commenting on the project noted that, "it underpins the principle of EDCTP working in partnership with the European Commission, Member States, Product Development Partners and other Public and Private Partnerships to facilitate advancements in clinical research to fight HIV/AIDs, Malaria and Tuberculosis." EDCTP is currently funding 18 projects on TB vaccines and diagnostics. Aeras is a contributing partner on four of these projects.
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Scientists optimistic as Phase II TB trial progresses well
Written by Henry Neondo
Thursday, 27 January 2011
Sixty-four infants have been enrolled, to date, in a Phase II tuberculosis vaccine clinical trial in the Siaya District, Nyanza Province of Western Kenya.

The candidate vaccine is AERAS-402/Crucell Ad35, and is designed as a booster to the currently available TB vaccine.

The Kenya study is led by KEMRI/CDC, a joint research project of the Kenya Medical Research Institute and the Centers for Disease Control and Prevention.

The trial in Kenya is the first phase of a multi-center clinical trial co-sponsored by Aeras and is designed to evaluate dosing regimens for the second phase of the trial.

The second phase is designed to evaluate the efficacy of the candidate vaccine and includes expansion of the study into additional African research locations.
Dr. Grace Kiringa study coordinator for the AERAS-402/Crucell Ad35 trials in Kenya, says "the main purpose of the study at this point is to confirm and evaluate the safety profile of this new TB vaccine. So far, in previous studies that have been done in healthy adults, adults living with HIV and in healthy infants there have been no serious adverse events reported. And so, to the best of our knowledge, the vaccine is safe. This is extremely promising and critical to finding a new vaccine that will help put an end to the TB epidemic."
She adds that while HIV is a health priority in Kenya, it has also fueled a resurgence of TB which is now the leading cause of death in HIV patients. Dr. Kiringa notes, "The efforts to find an effective TB vaccine should be concurrent with HIV vaccine efforts because as you fight one, you also fight the other."
Significant support for this Phase II trial comes from the European and Developing Country Clinical Trials Partnership (EDCTP) through a consortium of African research institutes, which includes KEMRI/CDC.

Prof Charles Mgone, the EDCTP Executive Director, commenting on the project noted that, "it underpins the principle of EDCTP working in partnership with the European Commission, Member States, Product Development Partners and other Public and Private Partnerships to facilitate advancements in clinical research to fight HIV/AIDs, Malaria and Tuberculosis."

EDCTP is currently funding 18 projects on TB vaccines and diagnostics. Aeras is a contributing partner on four of these projects.

www.africasciencenews.org/asns/index....
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Leading UCT TB Vaccine Research Unit Awarded Major Grant

February 2011, Cape Town, South Africa - The University of Cape Town’s (UCT) South African Tuberculosis Vaccine Initiative (SATVI) is once again the recipient of major tuberculosis (TB) research funding. SATVI’s co-director, Prof. Willem Hanekom, was awarded a $5.3million (R36million) research grant by the Bill & Melinda Gates Foundation, to learn why some persons exposed to the TB germ develop TB disease, while others do not.
Worldwide, 9 million people develop TB disease annually, and 1.7 million die. Only 10% of people who are infected with the TB germ develop lung disease.
If successful, the research project can make a significant contribution to the fight against TB.
‘Our first aim is to learn what to measure in blood to indicate that an exposed person will develop TB disease. This will allow targeted intervention with antibiotics. The knowledge gained from our research should also guide development of new vaccines, to prevent TB altogether,’ explains Prof. Hanekom.
This 3-year project will bring together some of the world’s best scientists from Seattle, Stanford, San Diego and the Netherlands. The study will be led by Prof. Hanekom from UCT’s Faculty of Health Sciences.
The research team will analyse stored blood samples already collected from 6,363 adolescents. Nearly 50% of these adolescents were found to be infected with the TB germ at enrollment. Some developed TB disease during 2 years of follow-up, but most remained healthy. Stored blood will now be retrieved, to look for differences in immune responses between those that developed TB disease and those who remained healthy. The researchers will use cutting edge technology for their search for these ‘correlates of risk of TB disease’.
SATVI has grown from a staff of 13 in 2001 to a multi-skilled team of over 200 and is currently the leading clinical TB vaccine research site in the world. The group studies new vaccines to prevent TB, and addresses critical unanswered questions in TB vaccinology. SATVI’s study participants are enrolled at its site in the Worcester region, while laboratory tests are completed in Cape Town.

www.satvi.uct.ac.za/index.php/pdf/201...
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