Self Vaccine Immunology Statistical Center
OVERVIEW:
The Vaccine Immunology Statistical Center (VISC) is organized within the CAVD to provide services in the areas of statistical design and data analysis, a central repository for key CAVD studies, and support for laboratory data management. The diverse staff at VISC has expertise in the areas of biostatistics, immunologic assays, bioinformatics, data management, and information systems.
VISC ensures that CAVD studies are efficient by providing state-of-the-art statistical methods and, when required, develop novel methods. Specific areas of novel methodological development are the design of repeated low-dose challenge non-human primate studies, the analysis of immunologic checkerboard data, signal processing and normalization of flow cytometry-based assays, and network models for the analysis of multivariate outcomes in mouse immunogenicity experiments. The VISC team also designs data models for novel immunologic assays and engineers integrated data pipelines from lab instruments to the CAVD central data repository. Finally, VISC staff support data access, data sharing, and collaboration through a customized web portal available to the large community of CAVD investigators.
The VISC continues to assemble teams with expertise in biostatistics, immunologic assays, and information systems to assist CAVD investigators. The VISC team seeks to have the skills and flexibility necessary to address emerging needs quickly and to build effective, ongoing collaborative relationships. As the VISC moves forward it intends to work more with collaborators on best practices for study designs and data analysis, develop new and improved existing online tools, and settle upon standard nomenclatures and data formats to facilitate data sharing and communication.
RESEARCH OBJECTIVES:
- Develop, implement, and operate a Vaccine Immunology Data System (VIDS) for the standardized definition and uniform management of data from preclinical and clinical studies of HIV-related immunogens.
- Develop, implement, and operate a user-friendly web-based interface to the VIDS that includes tools for open access to and analyses of data, tools to seamlessly integrate and analyze information from other important HIV-related public data bases, and tools to facilitate communication, collaboration, and data exchange among CAVD researchers.
- Establish and operate a Biostatistics Unit that will provide state-of-the-art statistical collaboration to HIV-vaccine researchers.
PROGRESS:
The VISC continues to devote a large portion of its efforts towards assisting the CAVD Vaccine Immune Monitoring Consortia (VIMCs) with assay development and testing. These activities include improved data management, information exchange with investigators and lab personnel, study design, and statistical analysis.
Recent analytic and data support projects with the VIMCs included:
* Implementation of a proficiency testing program for the TZM-bl neutralizating antibody assay
* Support for the Neutralization Serotype Discovery Program
* Profiling the specificity of neutralizing antibodies in plasma panels
* Design and analysis for the testing and transfer of a standard CTC VIMC ELISpot assay to new labs
* Design, analysis and data support for the qualification of a standard ICS Flow assay
* Analysis and data support for testing nonhuman primate (NHP) T Cell assays
Additional biostatistical projects included:
* Developing statistical methods for evaluating vaccine efficacy and immunological surrogates of protection in repeated low-dose NHP challenge studies
* Developing methods for evaluating vaccine efficacy on viral load and on survival in NHP studies
* Mapping the specificities of neutralizing antibodies in broadly cross-reactive plasma
* Novel statistical analyses of mouse immunology data to infer specific mechanisms of vaccine action on primary endpoints
* Developing tools for predicting MHC-peptide binding, proteasomal cleavage and supertype classification
* Study designs for a Phase I clinical trial and NHP experiments