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Health Management Training to Enhance Influenza Vaccine Immunogenicity

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
John W. Denninger, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01256515
First received: December 7, 2010
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
No Conditions
 Behavioral: Health Education
Behavioral: Health Education Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Health Management Training to Enhance Influenza Vaccine Immunogenicity

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Immunoglobin antibody response [ Time Frame: pre and post following 8 weeks of health management training ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: June 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

General Inclusion criteria are the following:

  • age 50 years or older
  • Infectious Disease tests - negative HIV test; hepatitis B surface antigen; anti-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 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, corticosteroids (oral or inhaled)), G(M)-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 ADHD and current major depressive episode)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256515

Locations
United States, Massachusetts
Benson-Henry Institute, 151 Merrimac St, 4th Floor
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Centers for Disease Control and Prevention
Investigators
Principal Investigator: John Denninger, M.D., Ph.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: John W. Denninger, MD, PhD, Director of Research, Benson-Henry Institute, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01256515     History of Changes
Other Study ID Numbers: 2009P001437, 5R01DP000339
Study First Received: December 7, 2010
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Healthy adults aged 50 or older

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013