OPTIMALVAC

Initiative on Optimizing Malaria Vaccine Lab Assays Evaluation

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 Obiettivo del progetto (Objective)

'A broad-range of candidate malaria vaccines derived from diverse novel technologies have resulted from the multiple approaches being taken by different groups in developing malaria vaccines. The majority of the candidates are recombinant proteins based on complex native antigens found on the surface of the parasite. Vaccine potential of these parasite surface antigens is often supported by epidemiological data, and by the ability to induce specific antibodies or potential protective responses in animals and later, in humans. Individual groups have developed assays within the context of the vaccine discovery efforts, with identification of measurable processes for parasite growth and virulence to test specific antigens. In-house assays are strain, stage and even process specific and the ability to compare results between different candidates is further limited by diverse methodologies and assay components such as parasites, cells and reagents. The absence of some level of harmonization of practices also makes interpreting the meaning and relevance of vaccine research outcomes complex. Lack of an enabling environment for comparability of research results generated in different labs could unfortunately lead to scepticism of the results that in turn generate uncertainty about the efficacy of the vaccines and rationale of the development pathway. To compare the relative merits of different candidate vaccines and approaches in a credible and informed manner, efforts must be made to create this enabling environment by supporting the development of a baseline level of standardization around key assays that can be utilized a) in the evaluation of malaria vaccines, and b) throughout the Development process. Consistent, reproducible and comparable intra- and inter-lab performance and increased accuracy and precision of assay data, will strengthen the quality of the data on vaccine performance and generate greater confidence in the vaccine potential of the candidate.'

Introduzione (Teaser)

Through the development and exchange of reference reagents, standard protocols and software tools, the Optimalvac initiative aimed to provide a consensus platform for malaria-related research. Assay standardisation is important for the malaria vaccine technology roadmap.

Descrizione progetto (Article)

Diverse technologies and approaches have been utilised over the years to generate various malaria vaccines. Within these efforts and in order to test different antigens, research groups have developed specific assays using highly divergent reagents, cells and parasite strains.

Comparability of these research results generated in different laboratories is crucial for strengthening their overall validity and the efficacy of the developed vaccines. To achieve this, the EU-funded 'Initiative on optimising malaria vaccine lab assays evaluation' (Optimalvac) effort was designed to harmonise assays used in the evaluation of malaria vaccines.

By bringing together 12 partner institutions, the Optimalvac initiative concentrated on optimising assays and protocols for antibody recognition of parasite proteins (humoral assays), for cell-dependent parasite inhibition (functional assays) and for cell-mediated immunity.

The immune fluorescence assay (IFA) is an enhanced method for detecting parasite proteins in patient blood samples. Optimisation of the protocol during the Optimalvac project resulted in robust and reproducible antibody end-point titres for use in both pre-clinical and clinical tests. Similar results were obtained for the antibody-dependent cellular inhibition (ADCI) assay.

Regarding the enzyme-linked immunosorbent spot (ELISPOT) assay, which allows enumeration of the B lymphocytes that secrete antibodies, Optimalvac worked to identify the consensus reagents, protocol steps and results reading process. This would ensure assay uniformity across all consortium partners.

The extensive variability detected among partners in the intracellular cytokine staining (ICS) assay led to the development of a consensus data analysis platform.

The Optimalvac initiative succeeded in bringing malaria researchers to agree on developing consensus immunoassays for monitoring disease stage and vaccine efficacy. The involvement of research groups outside the consortium is a proof of the beneficial effect of such a uniform platform for future research activities.