Original Research

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

Robert K. Langat, Bashir Farah, Jackton Indangasi, Simon Ogola, Gloria Omosa-Manyonyi, Omu Anzala, Jean Bizimana, Emmanuel Tekirya, Caroline Ngetsa, Moses Silwamba, Enoch Muyanja, Paramesh Chetty, Maureen Jangano, Nancy Hills, Jill Gilmour, Len Dally, Josephine H. Cox, Peter Hayes
African Journal of Laboratory Medicine | Vol 10, No 1 | a1056 | DOI: https://doi.org/10.4102/ajlm.v10i1.1056 | © 2021 Robert K. Langat, Bashir Farah, Jackton Indangasi, Simon Ogola, Gloria Omosa-Manyonyi, Omu Anzala, Jean Bizimana, Emmanuel Tekirya, Caroline Ngetsa, Moses Silwamba, Enoch Muyanja, Paramesh Chetty, Maureen Jangano, Nancy Hills, Jill Gilmour, Len Dally, Jos | This work is licensed under CC Attribution 4.0
Submitted: 06 June 2019 | Published: 17 February 2021

About the author(s)

Robert K. Langat, Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya; and International AIDS Vaccine Initiative (IAVI), Human Immunology Laboratory, Imperial College, London,, United Kingdom
Bashir Farah, Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya
Jackton Indangasi, Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya
Simon Ogola, Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya
Gloria Omosa-Manyonyi, Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya
Omu Anzala, Kenya AIDS Vaccine Initiative, Institute of Clinical Research, University of Nairobi, Nairobi, Kenya
Jean Bizimana, Projet San Francisco, Kigali, Rwanda
Emmanuel Tekirya, Projet San Francisco, Kigali, Rwanda
Caroline Ngetsa, Kenya Medical Research Institute Centre for Geographical Medicine Research Coast, Mombasa, Kenya
Moses Silwamba, Zambia EMORY HIV Research Project, Lusaka, Zambia
Enoch Muyanja, Ugandan Virus Research Institute-IAVI, Entebbe, Uganda
Paramesh Chetty, International AIDS Vaccine Initiative, Johannesburg, South Africa
Maureen Jangano, Clinical Laboratory Services, Johannesburg, South Africa
Nancy Hills, School of Medicine, University of California, San Francisco, California, United States
Jill Gilmour, International AIDS Vaccine Initiative (IAVI), Human Immunology Laboratory, Imperial College, London, United Kingdom
Len Dally, Emmes Corporation, Rockville, Maryland, United States
Josephine H. Cox, Clinical Trials Program, Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, United States
Peter Hayes, International AIDS Vaccine Initiative (IAVI), Human Immunology Laboratory, Imperial College, London, United Kingdom


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Abstract

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.


Keywords

PBMC processing; peripheral blood mononuclear cells; ELISpot; clinical trials; good clinical laboratory practice; proficiency testing.

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