Aging Clinical Trial
Official title:
Factors Associated With Maintenance of Antibody Responses to Influenza Vaccine in Older, Community-Dwelling Adults
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.
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.
Age, co-morbid conditions, sex, and race were ascertained from participant interview. Recent
chemotherapy, radiation therapy, or use of immunomodulating medications were ascertained by
self-report or chart review. CDC-defined high risk medical conditions were identified by
self-report of organ transplantation, cancer, diabetes mellitus, splenectomy (functional or
anatomic), cardiovascular disease, renal disease, sickle cell disease, chronic pulmonary
disease, seizure disorder, immune deficiency, or dementia.2 Self-reported stress was
determined by asking participants to respond yes or no to the question "Have you suffered
psychological stress or acute disease in the past 3 months?" included as part of the Mini
Nutritional Assessment Questionnaire.3 Height and weight were measured by research study
staff and body mass index (BMI) was calculated as weight (kg) / height (m)2.
Laboratory Methods
Blood samples were processed, stored, and shipped by each institution's local Sample
Processing Core to Battelle (Columbus, OH). Hemagglutinin inhibition (HAI) testing was
performed in duplicate against the influenza vaccine strains in the 2009-2010 Northern
Hemisphere influenza vaccine. Although there is debate about the best correlate of
protection for influenza,4 seroprotection was defined as an HAI titer of ≥40 since it is the
correlate recognized by the United States Food and Drug Administration.5 Seroconversion was
measured at S2 and defined as a four-fold rise in HAI post-influenza vaccination compared to
pre-vaccination or ≥40 if S1 was <10. Maintenance of antibody response was measured in
participants with an S2 ≥40, and defined as an S3≥40. If duplicate HAI results were
discrepant by more than two fold, a third test was performed and the minimum result was
recorded.
Statistical Analysis
Multivariable logistic regression models were run for the binary outcomes seroprotection at
S2 and S3 and seroconversion at S2. Age, BMI, stress, high risk medical conditions (yes/no),
female gender, study site and transformed S1 titer were included in all models. Time in days
from S1 to S3 was included in models with S3 related outcomes as a continuous variable.
Restricted cubic splines were applied to age and BMI. All raw HAI titers were log
transformed using the method outlined by Beyer,6 changing dilution titers to integers with
HAI <10 coded as 0, 10 as 1, 20 as 2, 40 as 3 and so on. Interaction terms between age and
high risk status, and stress or age and sex were tested and were not included based on
non-significant p values of overall interaction terms. Figures were generated by predicting
the probability of having a HAI titer ≥40 by logistic regression. All analyses were done
using R version 2.12.2.
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Observational Model: Cohort, Time Perspective: Prospective
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