Health Management Training to Enhance Influenza Vaccine Immunogenicity

Study Overview
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Brief Summary
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The goal of this study is to assess the immunogenicity of inactivated influenza vaccination (IIV) in healthy elderly volunteers aged 50 years and older receiving one of two different health management trainings.

Detailed Description
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We will obtain preliminary data on the time it takes to achieve a protective immune response, durability of response and occurrence of influenza in the following influenza season. Promising results in this age group will provide preliminary data for expanded future studies in the elderly.

Official Title
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Health Management Training to Enhance Influenza Vaccine Immunogenicity

Conditions
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No Conditions

Intervention / Treatment
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* Behavioral: Health Education
* Behavioral: Health Education Training


Participation Criteria
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Eligibility Criteria
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General Inclusion criteria are the following: age 50 years or older Infectious Disease tests - negative HIV test; hepatitis B surface antigen; anti-hepatitis C virus (HCV) Routine Laboratory tests able and willing to complete the informed consent process able and willing to participate for the planned duration of the study, including availability for follow-up telephone contact General Exclusion criteria self report of any medical conditions for which the Center for Disease Control (CDC) states should not be vaccinated with IIV self-reported vaccination with the seasonal influenza vaccine for the current 2010-2011 influenza season (vaccination with the H1N1 influenza vaccine before, during, or after the study will not be exclusionary) history of hypersensitivity to any influenza vaccine components including thimerosal or egg history of Guillain-Barre syndrome self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins (IL), corticosteroids (oral or inhaled)), G(M)- cerebrospinal fluid (CSF)) in 4 weeks before enrollment or self reported history of IL-2 administration within 5 years self-reported use of theophylline preparations or warfarin because of the theoretical possibilities of enhanced drug effects and toxicities following influenza vaccination any clinically significant abnormalities found during a routine physical examination self-reported history of any autoimmune disease acute febrile illness on the day of intended immunization - immunization deferred until illness resolved self report of current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with compliance and ability to make study visits (such as severe attention deficit hyperactivity disorder (ADHD) and current major depressive episode)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Education Training Group 1<br>One form of health education training | Behavioral: Health Education<br>* CDs, techniques, advice, and group training pertaining to a healthier lifestyle. Both groups will have this intervention, but the specific type of health education training will vary between groups.<br>Behavioral: Health Education Training<br>* 8 weeks of group training regarding health education techniques.<br>|
| Active Comparator: Health Education Training Group 2<br>Another form of health education training | Behavioral: Health Education<br>* CDs, techniques, advice, and group training pertaining to a healthier lifestyle. Both groups will have this intervention, but the specific type of health education training will vary between groups.<br>Behavioral: Health Education Training<br>* 8 weeks of group training regarding health education techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunoglobin antibody response |  | pre and post following 8 weeks of health management training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy adults aged 50 or older