Preclinical Assays Needed to Predict Vaccine Efficacy

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Preclinical Assays Needed to Predict Vaccine Efficacy

Contributor: Sherry Ward, AltTox


Promising preclinical data for a candidate vaccine does not guarantee efficacy in phase II/III clinical trials. Thus, NIAID seeks novel preclinical assays capable of better predicting the likelihood of success in human clinical studies based on preclinical outcomes.

As researchers continue to identify new potential markers of protection, new opportunities to develop and qualify new or improved assays arise. These include:

  • Immunological assays to measure novel structural epitopes implicated in protection
  • Assays to measure promising markers of protection (e.g., cytokines, metabolites,¬†glycosylation state) identified through systems biology approaches
  • Assays using in vitro-reconstituted immune systems
  • Organoid-based assays
  • Refinement of existing assays to measure a predictive marker of protection
  • Evaluation of assays to determine predicted protection from disease using well-documented clinical samples

Successful applications will focus on a single, well-characterized investigational or licensed vaccine against one of the NIAID Emerging Infectious Diseases/Pathogens for which promising predictive markers of protection have been identified in human clinical studies.

Examples of supported assay development activities include the following:

  • Developing or optimizing assays using new or novel targets (e.g., biomarkers, antigens, epitopes)
  • Applying an existing qualified assay to a new candidate vaccine, biomarker, or antigen
  • Developing assay technologies such as nanotechnology and microfluidic-based systems, multiplex systems, robotics, or point of use technologies
  • Developing or optimizing next generation assay technologies

Proposed assay development and validation must use existing, well-characterized human clinical samples.

The complete funding opportunity announcement is available here:

Applications are due by September 30, 2015; Letters of Intent by August 30, 2015.