Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01827462
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : June 12, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Trivalent, inactivated influenza vaccine (TIV) Biological: Quadrivalent, inactivated influenza vaccine (IIV4) Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose) Phase 4

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 In 2008, 2012 and 2014, the cohort added additional participants to replace those who had withdrawn.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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immune Senescence in the Elderly: Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages
Actual Study Start Date : October 2007
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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 Name: Fluzone (IM)

Biological: Quadrivalent, inactivated influenza vaccine (IIV4)
Licensed Seasonal Influenza Vaccine IIV4
Other Name: 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 Name: Fluzone (IM)

Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
Licensed Seasonal High-Dose Influenza Vaccine TIV
Other Name: 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 Name: Fluzone (IM)

Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
Licensed Seasonal High-Dose Influenza Vaccine TIV
Other Name: Fluzone High-Dose (IM)




Primary Outcome Measures :
  1. Number of Participants Who Received the Influenza Vaccine [ Time Frame: Day 0 annually while on study ]

Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827462


Locations
Layout table for location information
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Principal Investigator: Cornelia L Dekker, MD Stanford University
Principal Investigator: Mark M Davis, PhD Stanford University
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Cornelia L. Dekker, Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT01827462    
Other Study ID Numbers: SU-03192011-7599
1U19AI090019-01 ( U.S. NIH Grant/Contract )
51731 ( Other Identifier: Bill and Melinda Gates Foundation )
AG-NS-0792-11 ( Other Identifier: Ellison Foundation )
First Posted: April 9, 2013    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by Cornelia L. Dekker, Stanford University:
Inactivated, trivalent influenza vaccine
elderly
immunosenescence
longitudinal study
Inactivated, High-Dose trivalent influenza vaccine
Inactivated, quadrivalent influenza vaccine
young adults
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs