Proteomic Profiling for Influenza

Influenza Clinical Trial

Official title: Proteomic Profiling for Influenza Vaccination

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate a new method of detecting the flu infection. This method may allow researchers to identify new proteins being made in response to an infection even before symptoms of the infection are present. The goal of this study is not to prevent the flu but to monitor the immune system response. The elderly and those with chronic health problems are at greater risk for complications (i.e., pneumonia, bronchitis [bacterial infection in the lungs], and sinusitis [bacterial infection in the sinuses]) from the flu. Early detection and diagnosis of the flu decreases the number of people with these complications. Participants will include healthy people between the ages of 21-40, between the ages of 60-89, or 90 years and older, who are living in the communities surrounding the 3 study sites in Virginia. There will be 5 study visits, and subjects will participate up to 1 month.

Clinical Trial Description

The central hypothesis of this study is that immune responses to vaccination can be quantified by proteomic profiling of serum (and other clinical fluids), and that the host responses to different infectious agents are unique and can be 'fingerprinted' by proteomics. Using influenza virus vaccination, this study proposes to use mass spectrometry platforms to profile and characterize proteins from serum samples obtained from recipients. These samples will be used to develop a proteomic profiling system for monitoring vaccine response and, eventually, early detection/diagnosis of infection. The long-term goal of this approach is to develop tools useful for reducing the morbidity and mortality of influenza from natural and potential bioterrorism-related infections by improving measures of vaccine efficacy and early diagnosis. The primary objective is to use surface-enhanced laser desorption/ionization time-of-flight (SELDI-TOF) mass spectrometry and matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry proteomic profiling tools to analyze a series of serum samples obtained from cohorts of young and elderly subjects, before and after trivalent split-virus influenza vaccination, to identify surrogate markers reflective of the immune response. The secondary objective is to use concurrent T-cell activation, cytokine assays, and hemagglutination inhibition (HI) serologic assays to correlate cellular and humoral responses to influenza vaccination with protein profiling changes. Comparisons of the protein profile data with the T-cell activation, cytokine assays, and HI results will be evaluated using multiple classification algorithms, and potential biomarker proteins will be identified by sequencing with either a MALDI-TOF or electrospray ionization mass spectrometer. Study Participants will include healthy adult volunteers between the ages of 21-40, between the ages of 60-89, or 90 years and older, who are living independently in the communities surrounding the 3 study sites in Virginia. There will be 5 study visits, and subjects will be in the trial for up to 1 month. The primary endpoint of the study is to identify surrogate markers reflective of the immune response and to correlate these markers to cellular and humoral responses (demonstrated with T-cell activation, cytokine assays, and the HI serologic assays) to influenza vaccination. The secondary endpoint is safety. Data on the following solicited local reactions (injection site pain, bruising, redness, tenderness, and induration) and solicited systemic reactions (fever, headache, malaise, myalgia, cough, runny nose, chills, vomiting, arthralgia, rash, and diarrhea) will be collected from Day 0-Day 14 and categorized as none, mild, moderate, and severe. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study by severity, duration, and relatedness to the vaccine. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

• NCT number: NCT00133588
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 4
• Start date: November 2006
• Completion date: January 2007