This research study is being done because influenza (the flu) affects many people each year throughout the world. The elderly and those with chronic health problems are at greater risk for complications (i.e., pneumonia, bronchitis [bacterial infection in the lungs], sinusitis [bacterial infection in the sinuses]) from the flu. Early detection and diagnosis of the flu decreases the number of people with these complications. The purpose of this research study is to evaluate one method of detecting the flu infection. This method may allow researchers to identify the 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.

Condition	Intervention	Phase
Influenza	Vaccine: Trivalent split Inf	Phase IV

Further Study Details: 

Expected Total Enrollment:  150

Bioengineering of the influenza virus to generate viral strains never previously seen in the human population remains a looming bioterrorism threat. Additionally, these strains could be engineered to be drug-resistant to current anti-influenza drugs. Introduction of a strain like this could have devastating consequences, essentially creating super-carriers of infection that would spread rapidly through the immune-naïve human population. This is not likely a realistic scenario at present, as only a few laboratories possess the requisite tools to generate recombinant virus stocks. However, this is likely to change within the next 5 years, and no guarantees can be made that the technology will not end up in the possession of bioterrorists and supporting nations. Developing high-throughput diagnostic methods and novel vaccine strategies to combat these possibilities for influenza, and other bioterrorist pathogens, remains a critical need for homeland defense. Healthy individuals who are living independently in the Hampton Roads communities near the Glennan Center will be invited to participate in the study. Participants must be between 21 and 40 years (young) or older than 64 years of age (elderly). The Glennan Center has a well-developed research program in influenza vaccine investigations, and annually, hundreds of local elderly volunteers participate in this research. Our central hypothesis is that immune responses to vaccination can be quantified by proteomic profiling of serum (and other clinical fluids), and that the host response to different infectious agents are unique and can be ''''fingerprinted'''' by proteomics. Using influenza virus, we propose to use mass spectrometry platforms to profile and characterize proteins from serum samples obtained from recipients of the intramuscular trivalent split vaccine (non-replicating). 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 our approach is to develop tools useful for reducing the morbidity and mortality of influenza from natural and potential bioterrorism infections by improving measures of vaccine efficacy and early diagnosis. The primary objective is to use SELDI-MS and MALDI-MS proteomic profiling tools to analyze a longitudinal series of serum samples obtained from a cohort of young and elderly patients, before and after trivalent split influenza vaccination, to identify surrogate markers reflective of the immune response. The secondary objective is to use concurrent T-cell activation 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 and HI results will be evaluated using multiple classification algorithms, and potential biomarker proteins will be identified by sequencing with either a MALDI-TOF/TOF or electrospray ion-trap tandem mass spectrometer.

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

1. Healthy males and females 21 to 40 years of age or 65 and older;
2. Subjects must provide written informed consent;
3. Subject is judged to be healthy on the basis of verbal history;
4. Subject is able to cooperate with the requirements of the study (read, write, and speak English, and will be available for 1 month after enrollment);
5. Subject is mentally capable to give consent based on investigator judgment;
6. Females of childbearing potential (as determined by the investigator or licensed clinician) must practice abstinence or must agree to use an effective method of birth control (eg, oral contraceptives; diaphragm or condom in combination with contraceptive jelly; cream or foam; intrauterine device; Depo-Provera (R); skin patch; vaginal ring or cervical cap) for 30 days prior to vaccination and must agree to continue using this method during the entire duration of the study and for at least 2 months after study completion;
7. Subject must have access to telephone service.

Exclusion Criteria:

1. Subject did not receive an influenza vaccine in the previous flu season (fall 2004);
2. Subject had influenza at any time during the past 2 years;
3. Subject received an influenza vaccine 6 months preceding enrollment in the study;
4. Subject received any vaccine 14 days before starting this study or plans to receive any vaccine during this study;
5. Subject received blood or blood products in the last 3 months;
6. Subject is allergic to eggs, contact lens solution, or has ever had a severe reaction to any influenza vaccine;
7. Subject is allergic to latex rubber;
8. Subject has known or suspected disease(s) of the immune system;
9. Subject has underlying unstable chronic disease such as uncontrolled hypertension, congestive heart failure, recent heart attack, liver and kidney disease, etc;
10. Subject is taking certain medications, eg, immunosuppressive agents or tamoxifen, or medications for cancer, arthritis, or asthma;
11. Subject is pregnant or planning to become pregnant within the next 2 months;
12. Subject is breastfeeding;
13. Subject has a history of allergic disease or reactions likely to be exacerbated by any component of the study vaccine, including a history of anaphylaxis or serious vaccine reaction;
14. Subject has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); diabetes mellitus, if well controlled, dependent diabetes is excluded as defined by need for dose adjustment in the past 3 months; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); arteriosclerotic event during the 2 weeks prior to enrollment (eg, history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack);
15. Subject has a history of severe reactions following immunization with influenza virus vaccines;
16. Subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol;
17. Subject has acute respiratory or other active infections or illnesses;
18. Subject has any active neurologic disorders;
19. Subject as a prior history of Guillain-Barré Syndrome.

Please refer to this study by ClinicalTrials.gov identifier  NCT00133588

Richard Drake      (757) 446-5656 

Virginia
      Eastern Virginia Medical School, Norfolk,  Virginia,  23507,  United States

Study ID Numbers:  05-0044
Last Updated:  August 22, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00133588
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23