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Immune Responses to Influenza Vaccine Among Healthy Employees Working at Roswell Park Cancer Institute and the Relationship to Vitamin D Status


N/A
18 Years
64 Years
Open (Enrolling)
Both
Healthy, no Evidence of Disease

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Trial Information

Immune Responses to Influenza Vaccine Among Healthy Employees Working at Roswell Park Cancer Institute and the Relationship to Vitamin D Status


PRIMARY OBJECTIVES:

I. To examine the effect of 25-hydroxy vitamin D3 levels on the immunologic response
(antibody responses week 4 [4 weeks (+/- 7 days)] post-vaccination) to the injectable
seasonal (2011-2012) trivalent influenza vaccine among Roswell Park Cancer Institute (RPCI)
employees. (Observational component) II. To examine the effect of vitamin D3
(cholecalciferol) supplementation on the immunologic response (antibody response Week 16 [4
weeks (+/- 7 days)] post-vaccination) to the injectable seasonal (2012-2013) trivalent
influenza vaccine among RPCI employees. (Intervention component)

SECONDARY OBJECTIVES:

I. To track occurrences of flu-like illness in the study population from November 1, 2011
through April 1, 2012, using a standardized epidemiologic questionnaire. (Observational
component) II. To determine the relationship between 25-hydroxy vitamin D3 levels at time of
vaccination and its immunologic responses Week 20 (8 weeks [+/- 7 days]) and Week 24 (12
weeks [+/- 7 days]) following administration of the injected seasonal (2012-2013) trivalent
influenza vaccine. (Intervention component) III. To track occurrences of flu-like illnesses
in the study population from November 2012 through April 2013, using a standardized
epidemiologic questionnaire. (Intervention component) IV. To evaluate the association
between single-nucleotide polymorphisms (SNPs) and polymorphisms in the deoxyribonucleic
acid (DNA) sequence of vitamin-D3 metabolizing enzymes, measures of vitamin-D3 metabolism
(24,25 hydroxy [OH] vitamin D3) and response to seasonal (2012-201) trivalent influenza
vaccine. (Intervention component)

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive low-dose cholecalciferol orally (PO) once daily (QD) for 12 weeks,
followed by the seasonal (2012-2013) trivalent influenza vaccine intramuscularly (IM).

ARM II: Patients receive high-dose cholecalciferol PO QD for 12 weeks, followed by the
seasonal (2012-2013) trivalent influenza vaccine IM.

After completion of study treatment, patients are followed up periodically.


Inclusion Criteria:



Healthy individuals seen at the Employee Health Clinic who will be eligible to receive
influenza vaccine Willingness to comply with study expectations Subject or legal
representative must understand the investigational nature of this study and sign an
Independent Ethics Committee/Institutional Review Board approved written informed consent
form prior to receiving any study related procedure INTERVENTION COMPONENT ONLY: Willing
to suspend use of any other vitamin D supplementation during the 3 month treatment
interval; if currently using > 2,000 IU/day of vitamin D supplementation, must suspend use
30 days prior to enrollment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Effect of 25-hydroxy vitamin D3 levels on immunologic response (antibody responses) to injectable seasonal (2011-2012) trivalent influenza vaccine (Observational component)

Outcome Description:

Descriptive statistics will be used to assess for differences in the occurrence of self-reported flu-like illnesses in the study population.

Outcome Time Frame:

At 4 weeks post-vaccination

Safety Issue:

No

Principal Investigator

Martin Mahoney

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 203111

NCT ID:

NCT01561989

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263