Health Management Training to Enhance Influenza Vaccine Immunogenicity

Mass General Brigham

Status: Completed

Conditions: No Conditions

Treatments: Behavioral: Health Education Training; Behavioral: Health Education

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01256515

5R01DP000339 (U.S. NIH Grant/Contract)

2009P001437

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Health Education Training Group 1

Experimental group

Description:

One form of health education training

Treatment:

Behavioral: Health Education Training

Behavioral: Health Education

Health Education Training Group 2

Active Comparator group

Description:

Another form of health education training

Treatment:

Behavioral: Health Education Training

Behavioral: Health Education