Setting Up a Standardized Peripheral Blood Mononuclear Cells Processing Laboratory to Support Multi-center HIV/AIDS Vaccine and Intervention Trials

Abstract

Despite infrastructure and capacity challenges in Africa, significant development has been made in the number of laboratories supporting immunological and safety studies required for large-scale HIV/AIDS vaccine or intervention trials. In Uganda, cohorts participating in HIV intervention trials are often recruited from rural areas. To avoid transporting samples from intervention trial areas over long distances (120 km) to central laboratories in Entebbe, we set up a standardized peripheral blood mononuclear cells (PBMCs) processing laboratory at a field station in Masaka, southwest Uganda. The laboratory was well equipped and enrolled into the International AIDS Vaccine Initiative (IAVI) Quality Assurance (QA) program. Staff was trained in laboratory techniques and Good Clinical Laboratory Practice (GCLP). The laboratory received IAVI and GCLP accreditation in 2008. In this paper we describe the process and achievements of measures taken to overcome challenges, to build staff capacity, and to optimize the quality of the cells yielded. * PBMCs : peripheral blood mononuclear cells IAVI : International AIDS Vaccine Initiative QA : quality assurance GCLP : Good Clinical Laboratory Practice CTL : cytotoxic T lymphocytes Th : T helper UVRI : Uganda Virus Research Institute SOPs : standard operating procedures SPARTAC : short pulse anti-retroviral treatment at seroconversion S101 : sample 1, operator 1 S1O2 : sample 1, operator 2 S2O1 : sample 2, operator 1 S2O2 : sample 2, operator 2 ELISPOT : enzyme-linked immunosorbent spot CLS : Clinical Support laboratory DAIDS : division of AIDS