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OpenTrials
Completed

NCT Number: NCT01256515

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.

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Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benson-Henry Institute, 151 Merrimac St, 4th Floor

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Health Education

Behavioral

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.

Health Education Training

Behavioral

8 weeks of group training regarding health education techniques.

Primary outcomes

  1. Immunoglobin antibody response

    Time frame: pre and post following 8 weeks of health management training

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Dec 8, 2010
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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