Laboratory expansion to large-scale international HIV preventive vaccine trials.
OBJECTIVE
The purpose of this article is to describe the requirements for clinical laboratories supporting large-scale multinational trials of prophylactic AIDS vaccine trials and review the progress made.


RESULTS
There is an increasing need for laboratories in Africa, Asia and the Caribbean to support internationally initiated and funded clinical trials of preventive HIV vaccine candidates. A number of qualified laboratories are currently supporting AIDS vaccine trials in these regions, although there remains a need to develop capacity further. The standardization of all tests is key in order that data can be pooled and compared across multiple sites and products. Significant progress has been made towards this aim. The recent development of quality programmes including good clinical laboratory practices are key to ensuring data are reliable and meet the requirements of regulatory bodies. In addition, HIV diagnostic tests are being developed to distinguish true HIV infection from vaccine-induced antibodies.


CONCLUSIONS
Significant advances have been made to develop laboratories capable of supporting multinational AIDS vaccine trials.
aInternational AIDS Vaccine Initiative, Core Laboratory, Chelsea and Westminster Hospital, London, UK bDepartment of Molecular Medicine and Haematology, University of Witwatersrand, Johannesburg, South Africa cNational Institute for Communicable Diseases, Johannesburg, South Africa dDepartment of Retrovirology, AFRIMS/Henry M. Jackson Foundation, Bangkok, Thailand.
Jill W
JW
Gilmour
Wendy S
WS
Stevens
Clive
C
Gray
Mark
M
de Souza