Health Management Training to Enhance Influenza Vaccine Immunogenicity

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.

Study Overview

• Status: Completed
• Conditions: No Conditions
• Intervention / Treatment: Behavioral: Health Education; Behavioral: Health Education Training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Benson-Henry Institute, 151 Merrimac St, 4th Floor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health Education Training Group 1; One form of health education training	Behavioral: Health Education; 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.; Behavioral: Health Education Training; 8 weeks of group training regarding health education techniques.
Active Comparator: Health Education Training Group 2; Another form of health education training	Behavioral: Health Education; 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.; Behavioral: Health Education Training; 8 weeks of group training regarding health education techniques.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: John Denninger, M.D., Ph.D., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 7, 2010
• First Posted (Estimate): December 8, 2010

Study Record Updates

• Last Update Posted (Estimate): May 29, 2013
• Last Update Submitted That Met QC Criteria: May 28, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Healthy adults aged 50 or older
• Other Study ID Numbers: 2009P001437; 5R01DP000339 (U.S. NIH Grant/Contract)