Proof-Of-Principle Of A Technology Transfer Of A Dried Blood Virus Neutralisation Assay To A Gavi-Eligible Country.

Abstract

Background Global health clinical research is commonly led by high-income countries (HICs) as low- and middle-income countries (LMICs) 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, while LMICs carry the burden of life-threatening disease. Representative trials and research capacity strengthening in LMICs are needed to ensure global vaccine access and equity. This study aims to transfer an RSV neutralisation assay, which uses live cells and virus with inherent high variation, to a country eligible to receive support from the Gavi, the Vaccine Alliance. Methods Using a train-the-trainer approach, a Ghanaian researcher was trained in the Netherlands on the dried blood-based RSV neutralisation assay. Subsequently, a Dutch researcher visited Ghana to support the process of adapting the technique to the Ghanaian setting. In a previously validated RSV neutralisation 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. Results Training and technology transfer was deemed successful, which was defined as neutralisation measurements by the Ghana team and high concordance (Lin’s concordance correlation coefficient (CCC)>0.8). Neutralising 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. Conclusion We show successful transfer of an RSV neutralisation assay, thereby strengthening the laboratory research capacity in a Gavi-eligible country. Reliable measurement of RSV neutralising antibodies in a Gavi-eligible country and the use of dried blood can contribute to inclusion of LMICs in RSV vaccine development and access.