Health Management Training to Enhance Influenza Vaccine Immunogenicity

No Conditions Clinical Trial

Official title:

Health Management Training to Enhance Influenza Vaccine Immunogenicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256515
• Other study ID #: 2009P001437
• Secondary ID: 5R01DP000339
• Status: Completed
• Phase: N/A
• First received: December 7, 2010
• Last updated: May 28, 2013
• Start date: November 2009
• Est. completion date: June 2012

Study information

• Verified date: May 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• No Conditions

Intervention

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.
• Health Education Training
8 weeks of group training regarding health education techniques.

Locations

Country	Name	City	State
United States	Benson-Henry Institute, 151 Merrimac St, 4th Floor	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunoglobin antibody response		pre and post following 8 weeks of health management training	No