_'*PROVIDED. Aeras has an established track record of implementinglarge-scale,community-basedTB vaccine field trials in theI developingworld, and is currently developinga global network of TB vaccine trial sites. The objective of thisI application is to cooperate with the CDC to expand this global network of TB vaccine trial sites by preparingl communities for large (over 5,000 subjects) community-based clinical trials for the evaluation of new vaccine candidates for TB in multiple, diverse, global locations. The focus of activitiesproposedfor support in this application will be at a site in Andhra Pradesh, India. Tuberculosis is recognized as one of the top three causes of death due to infectious disease. Despite the availability of inexpensive treatments that are effective in up to 95% of cases, the disease causes nearly 2 million deaths per year. In 1998, the US Department of Health and Human Services Advisory Council for Elimination of Tuberculosis and USPHS agencies convened a workshop to create a national strategy for development of effective tuberculosis vaccines, resulting in a """"""""Blueprint for Tuberculosis Vaccine Development"""""""". Subsequent focus and effort have yielded great progress, and at least six phase I trials of new vaccine candidates arc=,likely to have been or will be initiated between 2002 and 2005. To ensure adequate capacity to conduct phase III trial.,; in TB endemic areas, infrastructure development and training at community based field sites will be required. To achieve our objective of further development of the required network, we will complete four specific aims:
i Specific Aim 1 : To create a professional development program in Clinical Research Practice for the full range of staff needed in a large, community-based TB vaccine trial in India.
Specific Aim 2 : To develop laboratory capacity for advanced TB diagnosis and immunologic assays, logistics and systems that will meet regulatory standards, and develop referral systems to treat and cure patients with TB as required for a TB vaccine trial.
Specific Aim 3 : To conduct epidemiologic studies to characterize TB incidence and prevalence, and to conduct observational cohort studies that will mimic the conduct of a vaccine trial.
Specific Aim 4 : Refine information on TB prevalence and incidence in neonatal and adolescent cohorts in th_ proposed vaccine trials site. _=_eras recognizes the extensive epidemiological and technical tuberculosis experience and expertise of the Centers for IDisease Control and Prevention, and welcomes the ODDOrtunittvo collaborate with the CDC to achieve these aims.
