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IMPAACT P1073

This study is performed in collaboration with KIDCRU, and the International Maternal Peadiatric Adolescent AIDS Clinical Trials Group (IMPAACT). This protocol will study TB or BCG-related IRIS at selected international sites. TB symptoms or BCG complcations may appear with severe inflammation in a child soon after starting HAART. Complications following routine BCG vaccination occur in 1-2% of children in countries where BCG is given at birth to infants to prevent TB. Although the WHO recommends not giving BCG to HIV-infected newborn infants, the vaccine is being given at birth to all HIV-exposed infants because of the difficulties associated with early diagnosis and the fear that the vast majority of infants who will be HIV-uninfected might miss an opportunity to receive the vaccine.

BCG-IRIS is a BCG complication occurring after starting HAART, but it is not a reason to stop HAART. The triggers of IRIS are yet to be determined, and this study aims to contribute to the understanding of this phenomena. Children with a low CD4 T-cell count upon commencement of HAART are especially at risk for IRIS. IRIS events usually happen in the first 3 months of starting HAART. However, IRIS may occur as late as 9 months after starting HAART in rare cases.

This study will help to describe what happens  during IRIS, how often it occurs, identify factors that place an infant at risk, and investigate how the immune system contributes to this phenomenon. This can help  doctors to recognize signs and symptoms of IRIS earlier and provide a better treatment outcome. It will further provide additional insight into IRIS, which may lead to the development of new therapies for preventing and treating this serious disorder.

We are one of eight international laboratory sites in India, South Africa, Tanzania, Uganda and Zimbabwe who are processing the samples for the study.

Vaccine research at SUNIRG

We are currently performing the immunogenicity research for phase I and IIa/b TB vaccine trials (with VPM) ongoing in Cape Town South Africa. All our immunogenicity assays for the quantification of immune responses to the vaccine are based on commercially available (Quantiferon) and published methods (both short term and long term assays). Testing of the vaccine responses in the phase II trials are aproached through a series of whole blood assays where blood from the newborns vaccinated with either test vaccine or routinely administered BCG vaccine are co-incubated and characterised by either ELISA, multi colour flow cytometry, ELISPOT or proliferation assays. All the accumulated vaccine data are entered into our customized and tested databases which standardizes the process and makes transfer of data to the clinical trial statistician possible in an encrypted fashion.

?Apart from the current vaccine trial immunogenicity testing on going in our department, members of the group are also involved in vaccine research projects (eg TBTEA) and are often required to provide guidance on possible vaccine induced Biomarkers of TB.