AU-St Jude

PROJECT SUMMARY

 Background

Africa University – St. Jude project was established in 2006 in collaboration with and sponsored by St Jude Children’s Research Hospital (SJCRH) in Memphis, Tennessee, USA. This project involved the set up and establishment of Africa University Clinical Research Centre (AUCRC) in preparation for an HIV vaccine trial and lasted for three years. Sadly, due to some unfavourable developments on the international platform regarding an unrelated HIV vaccine that had been tested in a number of countries, the sponsor withdrew the HIV vaccine study in 2008. The purpose of the DVP ZIM study was to evaluate the safety and tolerability of a candidate preventive HIV vaccine in the city of Mutare, Zimbabwe. This was necessitated by high incidence of new HIV infections in sub-Saharan Africa by then therefore; an effective vaccine was seen as essential to halt the spread of HIV.

 Lack of local competing clinical trials in Mutare was also seen as strength to conduct this study because it enabled both staff and community to focus on the HIV vaccine trial without competing trials seeking volunteers from the same population pool and this was going to enhance recruitment rates. Despite the study being halted, AUCRC had already been established and capacity building for all staff to conduct and manage clinical trials had been enhanced. All CRC HOD staff, PIs and Co-Investigators received a 3-week protocol training at St. Jude Children’s Research Hospital in Memphis, Tennessee, USA. Infrastructure where AUCRC is currently housed was part of SJCRH capacitation including office and laboratory equipment. The research laboratory was also established at Africa University College of Health, Agriculture and Natural Sciences (CHANS).

Primary objective:

To evaluate the tolerability and safety of the multi-envelope D-D-V-P-D-P regimen in Zimbabwe population

Secondary objective:

To characterize the kinetics, duration and magnitude of the HIV-envelope specific immune responses elicited by the multi-envelope D-D-V-P-D-P regimen in a Zimbabwean population.

Some major achievement of AU-St Jude DVP ZIM collaboration

• Setting up of a Clinical Research Centre (CRC) infrastructure at Africa University.
• Setting up and equipping CRC Research Pharmacy with two – 80°C and -20°C freezers.
• Facilitated and sponsored registration of CRC Research Pharmacy with Medicines Control Authority of Zimbabwe (MCAZ).
• Facilitated the registration process of CRC Research Clinic with the Health Professional Authority (HPA).
• Trained all CRC staff on how to conduct and manage clinical trials.
• Networked CRC with the International Partnership for Microbicide (IPM) to run IPM 100.1 study.
• Setting up and equipping AU-College of Health, Agriculture and Natural Sciences Research Laboratory.

 Laboratory equipment to perform the following was supported by SJCRH:

• Haematology (complete full blood count)
• Chemistry: Analyzer that can perform at least 48 programmable tests
• Microbiology
  • Wet mounts
  • BV Grain stains
• PBMC extraction
• Flow Cytometry
• Cardiac markers
• Preparation of cell lysetes

Additional equipment included:

• -80°C and -20°C freezers
• Fridges
• Temperature controlled centrifuge
• Bio-specimen storage facilities
• Generator and UPS (Inverter) for power back-up

Despite the halting of the DVP ZIM study, St. Jude built capacity for CRC to conduct and manage clinical trials.