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  BSL3 laboratory  
 

President Museveni and Makerere University Inaugurate Lab and Clinical Facility for Tuberculosis Vaccine Studies in Uganda
New clinical trial site is one of few in the world capable of conducting large-scale studies of new TB vaccines

 

KAMPALA, UGANDA – 28 August 2009 – The Makerere University Infectious Disease Institute (IDI) announces today the opening of a new laboratory and clinical facility that will be critical to conducting world-class tuberculosis (TB) vaccine clinical trials in Uganda. Ugandan President Yoweri Museveni, Makerere University officials, and Dr. Jerald Sadoff, President and CEO of the Aeras Global TB Vaccine Foundation today participated in a ribbon-cutting ceremony to inaugurate the new mycobacteriology laboratory at Makerere University’s Department of Medical Microbiology in Kampala. The laboratory is specially designed to work with the bacterium that causes TB and has the capability to detect difficult-to-diagnose TB infection.

LAUDATORY QUOTE FROM PRESIDENT MUSEVENI

Yesterday, officials from IDI and the Iganga/Mayuge Demographic Surveillance Site, as well as Dr. Sadoff, opened a case verification ward at Buluba Hospital in Iganga, which includes state-of-the-art equipment that will allow researchers to establish whether babies are infected with TB.

QUOTE BY MOSES OR PHILIPPA, OR BOTH, ABOUT TB IN UGANDA AND THE IMPORTANCE OF THE LAB AND CASE VERIFICATION WARD

The currently available TB vaccine, Bacille Calmette-Guérin (BCG), was developed nearly 90 years ago and provides some protection against serious forms of TB in children. However, it is not reliable against pulmonary TB, which accounts for most cases of TB. Although BCG is the most widely administered vaccine around the world, there has never been more TB in the world than now. A new TB vaccine could help improve the effectiveness of BCG to prevent more people from becoming ill with TB.

“Uganda is one of the countries most severely affected by the TB epidemic, so I am very pleased to be working with Makerere University’s Infectious Disease Institute, which is a lead institute in Uganda that is preparing for future clinical trials of new TB vaccines,” said Dr. Sadoff of Aeras. “IDI is equipped to conduct clinical trials to the highest international scientific and ethical standards and will be instrumental in the search for a new TB vaccine that could save millions of lives from TB.”

The mycobacteriology laboratory was funded by Aeras, and the Makerere University Department of Medical Microbiology provided space. The European and Developing Countries Clinical Trial Partnership (EDCTP) will provide ongoing support for the lab.  The case verification ward was funded by EDCTP and Aeras, with space provided by Buluba Hospital.

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About the Infectious Disease Institute
The Infectious Diseases Institute (IDI) is a Uganda-registered NGO, owned by Makerere University. IDI conducts care, training and research for HIV and related infectious diseases. IDI envisions a healthy Africa, free from the burden of infectious diseases. The Institute’s mission is to build capacity of health systems in Africa for the delivery of sustainable, high quality care and prevention of HIV/AIDS and related infectious diseases through training, research and advanced clinical services. www.idi.ac.ug
 
About the Aeras Global TB Vaccine Foundation
Aeras is a non-profit organization working as a Product Development Partnership to develop new tuberculosis vaccines and ensure that they are distributed to all who need them around the world. Aeras collaborates with academia, industry, foundations and governments to develop new TB vaccine candidates and delivery systems, manufacture vaccines at low cost and establish intellectual property rights to assure their future availability and affordability. Aeras is currently funded by private foundations and government agencies and has six TB vaccine candidates in the pipeline, four of which are in clinical trials in Africa, Europe and North America. Aeras operates a state-of-the-art manufacturing and laboratory facility in Rockville, Maryland, USA and has an office in Cape Town, South Africa. www.aeras.org

About Tuberculosis
Tuberculosis is the world's second deadliest infectious disease, with nearly 9.3 million new cases diagnosed in 2007. According to the World Health Organization (WHO), an estimated 1.8 million people died from TB in 2007. One-third of the world's population has been infected with the TB bacillus and current treatment takes 6­-9 months. The current TB vaccine, Bacille Calmette-Guérin (BCG), developed nearly 90 years ago, reduces the risk of severe forms of TB in early childhood but is not very effective in preventing pulmonary TB – the infectious and most common form of the disease. Tuberculosis is now the leading cause of death for people living with HIV/AIDS, particularly in Africa. Multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) are hampering treatment and control efforts.

About Tuberculosis in Uganda
Uganda ranks 16th on the list of 22 high-burden tuberculosis (TB) countries in the world. In 2007, the country had more than 102,000 new TB cases, with an estimated incidence rate of 330 per 100,000 population. Insufficient resources, non-adherence to TB treatment, poor access to health care services, and a limited number of skilled staff and diagnostic facilities all contribute to the TB epidemic in Uganda. HIV/AIDS further exacerbates the problem of TB control and according to WHO, around 39 percent of new TB patients in Uganda are HIV-positive.

 

Uganda Mycobacteriology Lab Opening Q&A
28 August 2009

What is the state of the TB epidemic globally?
Tuberculosis is the world's second deadliest infectious disease, with nearly 9.3 million new cases diagnosed in 2007. According to the World Health Organization (WHO), an estimated 1.8 million people died from TB in 2007. One-third of the world's population has been infected with the TB bacillus and current treatment takes 6­-9 months. The current TB vaccine, Bacille Calmette-Guérin (BCG), developed nearly 90 years ago, reduces the risk of severe forms of TB in early childhood but is not very effective in preventing pulmonary TB – the infectious and most common form of the disease.

Tuberculosis is now the leading cause of death for people living with HIV/AIDS, particularly in Africa. Multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) are hampering treatment and control efforts.

Today’s most commonly used TB diagnostic, sputum microscopy, is more than 100 years old and lacks sensitivity, detecting only half of the world’s new TB patients. Delay in proper diagnosis costs patients valuable time and money in receiving treatment.

Is TB a problem in Uganda?
Uganda ranks 16th on the list of 22 high-burden tuberculosis (TB) countries in the world. In 2007, the country had more than 102,000 new TB cases, with an estimated incidence rate of 330 per 100,000 population. Insufficient resources, non-adherence to TB treatment, poor access to health care services, and a limited number of skilled staff and diagnostic facilities all contribute to the TB epidemic in Uganda.  HIV/AIDS further exacerbates the problem of TB control and according to WHO, around 39 percent of new TB patients in Uganda are HIV-positive.

Why is a new TB vaccine necessary if most Ugandans have already been vaccinated with BCG?
The currently available TB vaccine, Bacille Calmette-Guérin (BCG), was developed nearly 90 years ago and provides some protection against serious forms of TB in children.  However, it is not reliable against pulmonary TB, which accounts for most of the worldwide disease burden.  Although BCG is the most widely administered vaccine around the world, there has never been more TB in the world than now.  A new TB vaccine could help improve the effectiveness of BCG to prevent more people from becoming ill with TB. 

Who is conducting TB vaccine research in Uganda?
The Infectious Diseases Institute (IDI), based at Makerere University, is the lead institute in Uganda conducting clinical epidemiological studies and preparing for future clinical trials of new TB vaccines. IDI/Makerere University is collaborating with the Aeras Global TB Vaccine Foundation (a non-profit product development partnership with six new TB vaccine candidates under development), the European and Developing Countries Clinical Trials Partnership (EDCTP) and other partners to establish a clinical trial field site in Iganga, Uganda. Aeras and EDCTP with IDI, Makerere University School of Public Health (MUSPH) and other partners have established clinical facilities (including a TB case verification ward and a state-of-the-art negative airflow procedure room) at St. Francis Buluba Hospital and administrative offices on the Iganga/Mayuge Demographic Surveillance Site (DSS) grounds.  The case verification ward at Buluba Hospital, to be launched 27 August 2009, will be critical to establish the endpoints needed for infant epidemiological studies and clinical trials. The ward will allow researchers to establish whether babies have TB infection by collecting sputum for two mornings in babies suspected of having TB, after they have gotten a tuberculin skin test and chest x-ray. The case verification ward was funded by EDCTP and Aeras, with space provided by Buluba Hospital.

A new TB diagnosis laboratory based at the Makerere University College of Health Sciences built with support from Aeras will be officially opened by University Officials and President Museveni on 28 August 2009.

What is a Mycobacteriology Laboratory?  Why is it needed?

What is special about this lab?
The laboratory, headed by Dr. Moses Joloba, the Head of the Department of Microbiology, is built with world-class TB diagnostic capacity.  Therefore, normally difficult to detect TB infection will be diagnosed here. 

It is a high-containment BioSafety level 2/3 (or BSL2+) laboratory.  This designation means that it is designed to maximize safe working conditions for the handling of agents that would otherwise pose moderate risk to personnel and the environment.  The new laboratory meets the internationally recognized Good Laboratory Practices (GLP) standards required for clinical trials, results of which will be presented to regulatory authorities for licensure applications.  

How will this lab be used?
The work of this laboratory will be critical for conducting a TB vaccine clinical trial at the highest international safety standards.  Volunteers for clinical studies will be tested for TB before they are enrolled and throughout the clinical study to detect the presence of TB in the population.  Diagnostic samples will be tested at this lab.

Will this lab improve the time it takes to diagnose TB for the average Ugandan citizen?

Are there any other labs like it in Uganda?

How much was invested in the development of the new lab?  Who contributed funding?

Equipment

$450,000.00

Salaries

$328,594.00

Construction

$150,000.00

TOTAL

$928,594.00

*Does not include consumables, since these are operating and recurring expenses.
*$129,000/year for lab salaries

The lab is funded by Aeras.  The Makerere University Medical School contributed space, supervision and some construction funds, and Sida/Sarec contributed some equipment and construction funds.  The EDCTP contributes to the ongoing running of the lab, including for funding consumables and staff.

 
     
 
     
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