Performance of International AIDS Vaccine Initiative African clinical research laboratories in standardised ELISpot and peripheral blood mononuclear cell processing in support of HIV vaccine clinical trials.

Autor: Langat RK; Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya.; International AIDS Vaccine Initiative (IAVI), Human Immunology Laboratory, Imperial College, London, United Kingdom., Farah B; Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya., Indangasi J; Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya., Ogola S; Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya., Omosa-Manyonyi G; Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya., Anzala O; Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya., Bizimana J; Projet San Francisco, Kigali, Rwanda., Tekirya E; Projet San Francisco, Kigali, Rwanda., Ngetsa C; Kenya Medical Research Institute Centre for Geographical Medicine Research Coast, Mombasa, Kenya., Silwamba M; Zambia EMORY HIV Research Project, Lusaka, Zambia., Muyanja E; Ugandan Virus Research Institute-IAVI, Entebbe, Uganda., Chetty P; International AIDS Vaccine Initiative, Johannesburg, South Africa., Jangano M; Clinical Laboratory Services, Johannesburg, South Africa., Hills N; School of Medicine, University of California, San Francisco, California, United States., Gilmour J; International AIDS Vaccine Initiative (IAVI), Human Immunology Laboratory, Imperial College, London, United Kingdom., Dally L; Emmes Corporation, Rockville, Maryland, United States., Cox JH; Clinical Trials Program, Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, United States., Hayes P; International AIDS Vaccine Initiative (IAVI), Human Immunology Laboratory, Imperial College, London, United Kingdom.
Jazyk: angličtina
Zdroj: African journal of laboratory medicine [Afr J Lab Med] 2021 Feb 17; Vol. 10 (1), pp. 1056. Date of Electronic Publication: 2021 Feb 17 (Print Publication: 2021).
DOI: 10.4102/ajlm.v10i1.1056
Abstrakt: Background: Standardisation of procedures for performing cellular functional assays across laboratories participating in multicentre clinical trials is key for generating comparable and reliable data.
Objective: This article describes the performance of accredited laboratories in Africa and Europe on testing done in support of clinical trials.
Methods: For enzyme-linked immunospot assay (ELISpot) proficiency, characterised peripheral blood mononuclear cells (PBMCs) obtained from 48 HIV-negative blood donors in Johannesburg, South Africa, were sent to participating laboratories between February 2010 and February 2014. The PBMCs were tested for responses against cytomegalovirus, Epstein Barr and influenza peptide pools in a total of 1751 assays. In a separate study, a total of 1297 PBMC samples isolated from healthy HIV-negative participants in clinical trials of two prophylactic HIV vaccine candidates in Kenya, Uganda, Rwanda and Zambia were analysed for cell viability, cell yield and cell recovery from frozen PBMCs.
Results: Most (99%) of the 1751 ELISpot proficiency assays had data within acceptable ranges with low responses to mock stimuli. No significant statistical difference were observed in ELISpot responses at the five laboratories actively conducting immunological analyses. Of the 1297 clinical trial PBMCs processed, 94% had cell viability above 90% and 96% had cell yield above 0.7 million per mL of blood in freshly isolated cells. All parameters were within the predefined acceptance criteria.
Conclusion: We demonstrate that multiple laboratories can generate reliable, accurate and comparable data by using standardised procedures, having regular training, having regular equipment maintenance and using centrally sourced reagents.
Competing Interests: The authors have declared that no competing interests exist.
(© 2021. The Authors.)
Databáze: MEDLINE
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