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Proposal 1132

Title of the Proposed Research

Cytokine patterns in anti-viral disease vaccines: a knowledge driven approach

Lead Researcher

Atul J. Butte, MD, PhD

Affiliation

Stanford University
Stanford, CA
USA

Funding Source

This research will be funded by National Institute of Allergy and Infectious Diseases, Division of Allergy, Immunology and Transplantation, contract HSN272201200028C

Potential Conflicts of Interest

None

Data Sharing Agreement Date

14 May 2015

Lay Summary

Cytokines, key regulators of the immune system, play a central role in both health and disease. These small proteins are secreted from a variety of cell types including, but not limited to, immune cell types and are involved in many biological processes. Cytokines have been implicated both as possible diagnostics markers and therapeutics targets. For example, Interleukin 18 (IL-18) has been identified as an early diagnostic marker for acute kidney injury (Parikh, Abraham et al. 2005) while Tumor Necrosis Factor alpha (TNF-a) is a therapeutic target for rheumatoid arthritis (Feldmann 2002). Another important aspect of immunity in health and disease involves different immune cell types such as lymphocytes, leukocytes, macrophages, basophiles and eosinophils in fighting infections, inflammatory responses, allergic reactions etc.

The availability of immune-related data is dramatically increasing, making such data an attractive source for systemic research. However, with the rapid growth of biomedical knowledge, integration of different data sources is becoming more crucial. Access to information, analysis of data, and integration of knowledge are key components of biomedical research. Scientists now must be able to integrate their data with other data, to combine information from multiple sources, and to compare their results to prior knowledge.

To date, integrated immune-related data, such as text-mined cytokine-disease relationships, cytokine level measurements and cell counts, have not been systematically and methodically examined. Examining disease-related cytokine patterns can help gain better insight into disease-related immune characteristics and find immune-related similarities and differences between diseases. As a use case to our knowledge-driven approach, this research aims to elucidate cytokine-related patterns in a verity of different anti-viral vaccines based on open clinical trial data. Using the control and vaccinated arms of several different clinical trials, we aim to identify those vaccine related immune patterns and use them to characterize and compare between the different vaccines against diseases.

Study Data Provided

Study 108933: Phase IIIb, Observer-blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus (HPV-6,11,16,18 L1 VLP) Recombinant Vaccine Merck & Co., Inc.]
Study 110223: Reactogenicity and immunogenicity of GSK Biologicals' influenza vaccine GSK576389A in elderly adults (≥67 years) previously vaccinated with the same candidate vaccine. Fluarix™ will be used as reference.
Study 110794: Immunogenicity, safety and reactogenicity of GSK Biologicals' influenza vaccine GSK1247446A with various formulations in subjects aged 18-64 years
Study 109801: Complementary testing to further evaluate the immunogenicity of a GSK Biologicals’ HPV vaccine (580299) in healthy female subjects aged over 26 years enrolled in study 104820.
Study 108251: Evaluate immunogenicity & safety of a single or double-dose of the pandemic influenza candidate vaccine (GSK1562902A) given following a two-administration schedule (21 days apart) in adults over 60 yrs
Study 107863: Evaluation of the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV vaccine 580299 (Cervarix TM) in adult human immunodeficiency virus (HIV) infected female subjects

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation