Clinical trial NCT01256515: Health Management Training to Enhance Influenza Vaccine Immunogenicity
Official title: Health Management Training to Enhance Influenza Vaccine Immunogenicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Conditions
Keywords: Healthy adults aged 50 or older
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2010-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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)

Primary outcomes:
measure: Immunoglobin antibody response
timeFrame: pre and post following 8 weeks of health management training
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Benson-Henry Institute, 151 Merrimac St, 4th Floor
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: John Denninger, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: