Technology transfer of a dried blood virus neutralization assay to a GAVI-eligible country

Abstract

ABSTRACTBackgroundGlobal health clinical research is commonly led by high-income countries (HICs) as low- and middle-income countries face barriers to participate, including lack of financial and human capacity and lack of research environment. Respiratory syncytial virus (RSV) vaccine development is also led by HICs, preventing global vaccine access while LMICs carry the burden of life-threatening disease. This study aims to transfer an RSV neutralization assay, which uses live cells and virus with inherent high variation, to a GAVI-eligible country.MethodsUsing a train-the-trainer approach, a Ghanaian researcher was trained in the Netherlands on the dried blood-based RSV neutralization assay. Subsequently, a Dutch researcher visited Ghana to support the process of adapting the technique to the Ghanaian setting. In a previously validated RSV neutralization assay on dried blood, Hep-2 cells were infected with a serial dilution of sample-virus mixture to determine the half-maximal inhibitory concentration. Fifty-one dried blood and serum samples were tested in parallel in both countries to assess concordance.ResultsTraining and technology transfer was deemed successful, which was defined as neutralization measurements by the Ghana team and high concordance (Lin’s concordance correlation coefficient (CCC) > 0.8). Neutralizing capacity measured in identical samples in Ghana and the Netherlands correlated highly (Lin’s CCC = 0.87; Spearman rho = 0.89) but was systematically lower in Ghana than the Netherlands.ConclusionWe show successful strengthening of the laboratory research capacity in a GAVI-eligible country. Reliable measurement of RSV neutralizing antibodies in a GAVI-eligible country and the use of dried blood can contribute to inclusion of LMICs in RSV vaccine development and access.FundingNoneKEY MESSAGESWhat is already known?The global health research divide is evident in respiratory syncytial virus (RSV) vaccine development, where vaccines are developed and available in high-income countries (HICs), despite low- and middle-income countries (LMICs) bearing the majority of the disease burden. Representative trials and research capacity strengthening in LMICs are needed to ensure global vaccine access and equity.What this study adds?In this newly established partnership, we used a train-the-trainer approach to transfer a low-tech dried blood live-virus neutralization assay from the Netherlands to Ghana, a GAVI-eligible country. A sample panel measured in parallel in both countries showed high concordance and correlation despite the difficulties of running a bioassay with inherently high variability while using distinct materials.How this study might affect research, practice, or policy?The Ghana laboratory will leverage the established RSV neutralization assay to serve as a research hub in Africa supporting other LMICs to perform clinical sample analysis and management of clinical trial samples, ultimately reducing barriers to clinical trials and vaccine access, thereby advancing the sustainable development goals.