What We Do - Clinical Research Division
The Aurum Institute’s Health Research is recognised by the South African National Research Foundation as a Research Institute. The Aurum Institute has five programmatic areas of research that include HIV Vaccines, HIV Treatment and Prevention, TB Vaccines, TB Treatment and Basic Sciences and Special Projects. The Aurum Institute has a Science Core comprised of scientists that are responsible for developing investigator-initiated research projects.
The research is implemented by two research operations units: The Clinical Research Division (CRD)1 and the Implementation Research Division (IRD)2.
The Clinical Research Division conducts all clinical phase (I through III with IV capability) investigator-initiated trials, network trials (such as the NIH HIV Vaccine Trials Network and AIDS Clinical Trial Group, EDCTP funded PANACEA), Product Development Partner trials (such as Aeras TB Vaccine Foundation, Alliance for New TB drugs, FIND),pharma trials and prospective TB/HIV associated follow-up cohort studies. The CRD is also responsible for basic science research. The Implementation Research Division conducts largely investigator-initiated research that includes epidemiology, large cluster randomized implementation studies and phase IIIb/IV clinical trials.
Aurum has an extensive clinical research infrastructure nested within its Clinical Research Division which includes four established Clinical Research Centres:
- Tembisa conducting LTBI, DS-TB, HIV and pharma trials plus a basic sciences TB-HIV co-infection prospective cohort follow-up study focussing on lung inflammation and TB-IRIS associated PET-CT lung imaging.
- Rustenburg conducting LTBI, DS-TB, MDR-TB and HIV, trials plus basic sciences LTBI / TB incidence prospective cohorts focussing on identifying design cues for second wave TB vaccine candidates (TB immunology).
- Klerksdorp conducting LTBI, DS-TB and HIV trials.
- Welkom Kopanong MDR-TB Clinical Research Centre with boundless access to MDR-TB potential participants and some pre-XDR potential participants.
Furthermore, the CRD has leveraged and secured collaborations with Vx Pharma, a state-of-the-art inpatient facility specialising in early-phase and pharmacokinetic studies. Vx Pharma, has established referral systems and access to less vulnerable study populations suitable for participation in HIV vaccine and TB vaccine trials. Existing relationships have paved the way to facilitating Aurum’s delivery of future vaccine studies nested within the HVTN trial networks at Vx Pharma. Recently the Winnie Mandela Clinic Research Centre in nearby Tembisa is already conducting an LTBI treatment study (WHIP3TB) and will be taking on HVTN 703 (mAb infusion study) and HVTN 705 (later phase HIV vaccine study). Interest has peaked in setting up Welkom for non-MDR TB work as a TB and HIV Vaccine facility. In-part EDCTP leveraged funding has already been successfully applied for.
Similarly, an impressive research infrastructure within the IRD exists with; nine prisons and more than 80 primary health clinics. Other populations that Aurum does research to include mines and peri-mine and mine labour-sending communities, high burden communities and taxi ranks.
Aurum has extensive experience in the disciplines required to implement large-scale studies including data management using electronic data capture systems and data fax, community mobilization, quality assurance and training. Aurum has managed phase I, IIa, III and IV clinical trials and managed multisite clinical trials in South Africa and the Southern and East Africa. Aurum has particular expertise in the design and execution of large, cluster-randomized studies.