Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages (SLVP015 2007-2017)

June 9, 2017 updated by: Cornelia L. Dekker, Stanford University

Immune Senescence in the Elderly: Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages

In this study the investigators are trying to understand how immune function declines in the elderly using annual influenza vaccinations as a model system. The longitudinal study began in 2007 and continued through early 2017.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants ranging in age from 18 to 100 at time of initial enrollment will be immunized annually with the seasonal influenza vaccine, Fluzone, on Day 0. Follow-up visits will be conducted on Day 6-8 and Day 28. Unsolicited adverse events are collected from immunization until the Day 28 visit, serious adverse events are collected for the entire time of study participation. A blood sample is collected pre-immunization and at each follow-up visit. Volunteers will be followed for up to 11 years, those too frail to come in for visits received annual phone calls to monitor health. Last annual influenza vaccines were given in Fall 2015.

The main basic research effort will be to collect safety data and follow medical history events in elderly and younger control subjects. Investigators will also look at immune responses to influenza vaccination. In 2008, 2012 and 2014, the cohort added additional participants to replace those who had withdrawn.

Beginning in 2014, those participants 65 years and older were immunized with High Dose trivalent Fluzone and younger participants received the quadrivalent formulation of Fluzone.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-30, 60-79, or 80-100 years, inclusive at time of initial enrollment
  • General good health and ambulatory at time of enrollment
  • No acute illness at time of vaccination
  • Willing and able to sign Informed Consent
  • Available for follow-up for the planned duration of the study
  • Acceptable medical history by screening evaluation and brief clinical assessment
  • All female subjects of childbearing potential must use an acceptable method of contraception and not become pregnant for the duration of the clinical phase of the study (approximately 1 month to completion of Visit 3). (Acceptable contraception may include implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).

Exclusion Criteria:

  • Prior off-study vaccination with trivalent or quadrivalent (depending no year) influenza vaccine (TIV or IIV4) or live attenuated influenza vaccine (LAIV) in the current flu season
  • Allergy to egg or egg products
  • Allergy to vaccine components, including thimerosal
  • Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  • History of immunodeficiency
  • Any chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  • Blood pressure >150 systolic or > 95 diastolic at Visit 1
  • Chronic Hepatitis B or C.
  • Recent or current use of systemic immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays and inhaled steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
  • Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  • History of blood dyscrasias or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  • Use of anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin, Plavix, Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
  • Receipt of blood or blood products within the past 6 months
  • Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
  • Receipt of inactivated vaccine within 14 days prior to vaccination
  • Receipt of live, attenuated vaccine within 60 days of vaccination
  • History of Guillain-Barré Syndrome
  • Pregnant or lactating woman
  • Use of investigational agents within 30 days prior to enrollment
  • Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
  • Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 18-30 year olds at enrollment

Licensed seasonal Fluzone (inactivated influenza vaccine):

Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season.

Beginning with 2014-2015 season, Quadrivalent, inactivated influenza vaccine (IIV4) was given.
Biological: Trivalent, inactivated influenza vaccine (TIV)
Licensed Seasonal Influenza Vaccine TIV
Other Names:
  • Fluzone (IM)
Biological: Quadrivalent, inactivated influenza vaccine (IIV4)
Licensed Seasonal Influenza Vaccine IIV4
Other Names:
  • Fluzone (IM)
EXPERIMENTAL: 60-80 year olds at enrollment

Licensed seasonal Fluzone (inactivated influenza vaccine):

Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season.

Beginning with 2014-2015 season, High-Dose trivalent, inactivated influenza vaccine (TIV High-Dose) was given.
Biological: Trivalent, inactivated influenza vaccine (TIV)
Licensed Seasonal Influenza Vaccine TIV
Other Names:
  • Fluzone (IM)
Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
Licensed Seasonal High-Dose Influenza Vaccine TIV
Other Names:
  • Fluzone High-Dose (IM)
EXPERIMENTAL: 80-100 year olds at enrollment

Licensed seasonal Fluzone (inactivated influenza vaccine):

Trivalent, inactivated influenza vaccine (TIV) was given through the 2013-2014 season.

Beginning with 2014-2015 season, High-Dose trivalent, inactivated influenza vaccine (TIV High-Dose) was given.
Biological: Trivalent, inactivated influenza vaccine (TIV)
Licensed Seasonal Influenza Vaccine TIV
Other Names:
  • Fluzone (IM)
Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
Licensed Seasonal High-Dose Influenza Vaccine TIV
Other Names:
  • Fluzone High-Dose (IM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Received the Influenza Vaccine
Time Frame: Day 0 annually while on study
Day 0 annually while on study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Related Adverse Events
Time Frame: Day 0 to Day 28 following each annual vaccination while on study
Related adverse events were recorded annually during this 10 year longitudinal study.
Day 0 to Day 28 following each annual vaccination while on study

Other Outcome Measures

Outcome Measure
Time Frame
Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 5-7 for T Cells and Antibody-secreting Cells (ASCs)
Time Frame: Day 0 to 7
Day 0 to 7
Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 28-32 for Responses to the Vaccine Antigens
Time Frame: Day 0-Day28
Day 0-Day28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2007

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (ESTIMATE)

April 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-03192011-7599
  • 1U19AI090019-01 (U.S. NIH Grant/Contract)
  • 51731 (OTHER: Bill and Melinda Gates Foundation)
  • AG-NS-0792-11 (OTHER: Ellison Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique ID code and the volunteer identity (except for age) will not be disclosed.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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