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Clinical Trials/NCT02401893
NCT02401893CompletedNot Applicable

Factors Associated With Maintenance of Antibody Responses to Influenza Vaccine in Older, Community-Dwelling Adults

Vanderbilt University0 sites510 target enrollmentStarted: September 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
510
Primary Endpoint
Maintenance of Immune Response using Hemagglutinin inhibition titers

Study Overview

Brief Summary

Little is known about factors associated with maintenance of hemagglutinin inhibition (HAI) antibodies after influenza vaccination in older adults so the investigators enrolled adults ≥50 years.

Detailed Description

In the United States, yearly influenza vaccination begins in August or September. However, influenza season can extend into April of the following year. The duration of protection from annual vaccination in older adults is unknown, and little is known about factors associated with the maintenance of response throughout the influenza season. This study evaluated factors associated with the immune response of older adults to trivalent influenza vaccine and the maintenance of antibody responses for the duration of the influenza season.

Subjects

Subjects were enrolled at two sites, Vanderbilt University Medical Center (Nashville, TN) and Marshfield Clinic Research Foundation (Marshfield, WI), during September and October 2009. Subjects were eligible for recruitment if they were ≥50 years of age and had no contraindication to influenza vaccination. Subject recruitment included advertisements at Vanderbilt University Medical Center and letters of invitation to older adults who had received an influenza vaccine in the year prior at Marshfield Clinic.1 All subjects were vaccinated either by their usual caregiver or by the study staff. Strain components for the 2009-2010 Northern Hemisphere vaccine included A/Brisbane/59/2007-like (H1N1), A/Brisbane/10/2007-like (H3N2), and B/Brisbane/60/2008-like. Participants were given the trivalent seasonal vaccine because the 2009 H1N1 pandemic vaccine was not available.

Data Collection

All subjects donated serum pre-vaccination (S1) during September through October 2009, 21 - 28 days post-vaccination (S2) and post-influenza season, May through July, 2010, approximately 250 days (8 months) post-vaccination (S3). Study procedures, informed consent documents and data collection forms were reviewed and approved by Institutional Review Boards at each of the study sites.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age >=50 years

Exclusion Criteria

  • •Prior vaccine allergy or history of guillain barre

Outcomes

Primary Outcomes

Maintenance of Immune Response using Hemagglutinin inhibition titers

Time Frame: 1 year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Keipp Talbot

Assistant Professor

Vanderbilt University

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