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Trial record 76 of 597 for:    Fluzone® | Studies With Results

T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 3, 2011

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ClinicalTrials.gov Identifier: NCT03022422
Recruitment Status : Completed
First Posted : January 16, 2017
Results First Posted : May 11, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Brief Summary:
This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.

Condition or disease Intervention/treatment Phase
Influenza Biological: TIV Biological: High-Dose TIV Phase 4

Detailed Description:

The investigators plan to study the response to influenza vaccines much more broadly and deeply across different age groups and with different vaccine formulations and to probe the influence of genetics on these responses using monozygotic and dizygotic twins. On an investigational basis, investigators plan to compare various immunological responses, identify age-specific biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of T-cell repertoire to an influenza vaccine within an individual as a function of age and to what degree this is genetically determined.

Twin Groups B-E will receive a single administration of the 2011-2012 formulation of seasonal trivalent inactivated influenza vaccine (TIV). Group F, elderly monozygotic twin participants, will be randomly assigned to receive a single dose of inactivated vaccine, either the usual dose or the High-Dose TIV. Blood samples to conduct the assays described will be taken at pre-immunization, Days 7-10 and 28 post-immunization. The number of individual participants, not the number of twin pairs is being reported in all the modules.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Protective Mechanisms Against a Pandemic Respiratory Virus: B-Cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 3, 2011
Study Start Date : September 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Group B: 18-30 yo identical twins (TIV)
Individual twins to receive Fluzone® standard TIV
Biological: TIV
Influenza Virus Vaccine Suspension for Intramuscular Injection
Other Name: Fluzone® TIV

Group C: 18-30 yo fraternal twins (TIV)
Individual twins to receive Fluzone® standard TIV
Biological: TIV
Influenza Virus Vaccine Suspension for Intramuscular Injection
Other Name: Fluzone® TIV

Group D: 40-64 yo identical twins (TIV)
Individual twins to receive Fluzone® standard TIV
Biological: TIV
Influenza Virus Vaccine Suspension for Intramuscular Injection
Other Name: Fluzone® TIV

Group E: 40-64 yo fraternal twins (TIV)
Individual twins to receive Fluzone® standard TIV
Biological: TIV
Influenza Virus Vaccine Suspension for Intramuscular Injection
Other Name: Fluzone® TIV

Group F: 65-100 yo identical twins (TIV)
Individual twins to receive Fluzone® standard TIV
Biological: TIV
Influenza Virus Vaccine Suspension for Intramuscular Injection
Other Name: Fluzone® TIV

Group F: 65-100 yo identical twins (High-Dose TIV)
Individual twins to receive High-Dose Fluzone® TIV
Biological: High-Dose TIV
High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for intramuscular injection
Other Name: High-Dose Fluzone® TIV




Primary Outcome Measures :
  1. Number of Individual Twins Who Received Influenza Vaccine [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Number of Individual Twins With Related Adverse Events [ Time Frame: Day 0 to 28 post-immunization ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Otherwise healthy, ambulatory adults, ages 18-30 years (identical or fraternal twin pairs), 40-64 years (identical or fraternal twin pairs) or 65-100 years (identical twin pairs).
  2. Willing to complete the informed consent process.
  3. Availability for follow-up for the planned duration of the study at least 28 days after immunization.
  4. Acceptable medical history and vital signs.

Exclusion Criteria:

  1. Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) in Fall 2011
  2. Allergy to egg or egg products, or to vaccine components, including thimerosal (if TIV multidose vials used)
  3. Allergy to latex (for Group F only - may be assigned to Fluzone High-Dose). Review with investigator.
  4. Life-threatening reactions to previous influenza vaccinations
  5. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  6. History of immunodeficiency (including HIV infection)
  7. Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  8. Blood pressure >150 systolic or > 95 diastolic at Visit 1
  9. Hospitalization in the past year for congestive heart failure or emphysema.
  10. Chronic Hepatitis B or C
  11. Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays, topical steroids and inhaled steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
  12. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
  13. 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.
  14. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  15. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except aspirin up to 325 mg.day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
  16. Receipt of blood or blood products within the past 6 months
  17. Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
  18. Inactivated vaccine 14 days prior to vaccination
  19. Live, attenuated vaccine within 60 days of vaccination
  20. History of Guillain-Barre Syndrome
  21. Pregnant or lactating woman
  22. Use of investigational agents within 30 days prior to enrollment
  23. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
  24. 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): NCT03022422


Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Cornelia Dekker, MD Stanford University
Principal Investigator: Mark Davis, PhD Stanford University
Principal Investigator: Garry Nolan, PhD Stanford University
Principal Investigator: Ann Arvin, MD Stanford University
Principal Investigator: Stephen Quake, PhD Stanford University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cornelia L. Dekker, Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT03022422     History of Changes
Other Study ID Numbers: SU-17219-2011
2U19AI057229-06 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2017    Key Record Dates
Results First Posted: May 11, 2017
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Product Manufactured in and Exported from the U.S.: No

Keywords provided by Cornelia L. Dekker, Stanford University:
Trivalent, inactivated influenza vaccine
High-Dose trivalent, inactivated influenza vaccine
Adult and elderly identical twins
Adult fraternal twins

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs