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T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 2, 2010

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ClinicalTrials.gov Identifier: NCT03022396
Recruitment Status : Completed
First Posted : January 16, 2017
Results First Posted : August 21, 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 response to influenza vaccines in monozygotic and dizygotic twins of different ages.

Condition or disease Intervention/treatment Phase
Influenza Biological: High Dose Fluzone® (intramuscular) Biological: Fluzone® (intramuscular) 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 A-E will receive a single administration of the 2010-2011 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. Each twin is counted as a single participant. All reporting numbers reflect the number of participants, not the number of twin pairs.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 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 2, 2010
Study Start Date : September 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Group A: age 8-17 yo identical twins
Individual twins to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Name: TIV

Group B: age 18-30 yo identical twins
Individual twins to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Name: TIV

Group C: age 18-30 yo fraternal twins
Individual twins to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Name: TIV

Group D: age 40 - 59 yo identical twins
Individual twins to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Name: TIV

Group E: age 40 - 59 yo fraternal twins
Individual twins to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Name: TIV

Group F: age 70 - 100 yo identical twins
Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
Biological: High Dose Fluzone® (intramuscular)
Licensed seasonal High dose trivalent inactivated influenza
Other Name: High Dose TIV

Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Name: TIV




Primary Outcome Measures :
  1. Number of Individual Twins Who Received Influenza Vaccine [ Time Frame: Day 0 to 28 ]
    All numbers reported are the number of participants, not the number of twin pairs. Each member of a twin was counted individually as a participant.


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

Inclusion Criteria:

  1. Otherwise healthy, ambulatory children or adults, ages 8-17 years (identical twins), 18-30 years (identical or fraternal twins), 40-59 years (identical or fraternal twins) or 70-100 years (identical twins).
  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.
  5. All female of childbearing potential, must use an acceptable method of contraception and not become pregnant for the duration of the study (approximately 1 month or to completion of Visit 3). (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).

Exclusion Criteria:

  1. Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) in Fall 2010
  2. Allergy to egg or egg products, or to vaccine components, including thimerosal (if TIV multidose vials used)
  3. Life-threatening reactions to previous influenza vaccinations
  4. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  5. History of immunodeficiency
  6. 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.
  7. Blood pressure >150 systolic or > 95 diastolic at Visit 1
  8. Hospitalization in the past year for congestive heart failure or emphysema.
  9. Chronic Hepatitis B or C
  10. Recent or current use of 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.
  11. 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).
  12. 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.
  13. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  14. Use of any 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.
  15. Receipt of blood or blood products within the past 6 months
  16. Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
  17. Inactivated vaccine 14 days prior to vaccination
  18. Live, attenuated vaccine within 60 days of vaccination
  19. History of Guillain-Barre Syndrome
  20. Pregnant or lactating woman
  21. Use of investigational agents within 30 days prior to enrollment
  22. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
  23. 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): NCT03022396


Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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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):
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Responsible Party: Cornelia L. Dekker, Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT03022396     History of Changes
Other Study ID Numbers: SU-17219-2010
2U19AI057229-06 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2017    Key Record Dates
Results First Posted: August 21, 2017
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cornelia L. Dekker, Stanford University:
Inactivated influenza vaccine
Identical twins
Fraternal twins
High-Dose influenza vaccine
Elderly twins
Child twins
Inactivated influenza vaccine, high-dose
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs