Evaluation technologies

The field needs new evaluation tools

The most significant challenge that malaria vaccine scientists face is a lack of understanding of the specific immune responses associated with protection against the parasitic disease. Successful development of evaluation tools, including assays and challenge models, that help elucidate protective immune responses in people is therefore a critical need.

The development of effective evaluation technologies to support both our pre-clinical and clinical programs is essential for MVI to successfully execute its strategy. Our chief areas of focus are immunological assays and challenge models, including those related to the development of newly supported Plasmodium vivax and transmission-blocking vaccine (TBV) approaches.

This range of activities should provide robust data to inform decision-making around the development of vaccine candidates and to reduce development investment risk. Our activities include:

• Identifying and engaging partners to drive the development and qualification of tools for assessing vaccine candidates.
• Upgrading the capabilities of existing reference and service centers for immunological assays.
• Supporting toxicology testing at a centralized toxicology testing service center.
• Supporting the development of standardized and high-quality control standards and reagents for the conduct of immunoassays.

MVI evaluation activities explained

Support for test centers

We have identified several labs with strong backgrounds in performing standardized assays and have engaged them in assay support activities on behalf of the malaria vaccine community. Activities include blinded testing of pre-clinical and clinical samples using standardized assays that enable comparison between different formulations and delivery platforms, as well as development of additional assays as needed to evaluate novel antigens.

Harmonization activities

Variability in procedures and types of assays hinders comparability among vaccine candidates. MVI supports several efforts aimed at identifying high quality reference reagents and acceptance of common methodologies.

Research and development

In cases where tools do not exist to identify and quantitate relevant immune responses, MVI engages research groups in developing or optimizing immunological assays and challenge models to improve our ability to develop strong vaccine candidates.