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T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009

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ClinicalTrials.gov Identifier: NCT01987349
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : May 12, 2017
Last Update Posted : May 12, 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 compare influenza vaccine responses in monozygotic and dizygotic twins.

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluzone® (intramuscular) Biological: FluMist® (intranasal) Phase 4

Detailed Description:
The investigators plan to study the response to different influenza vaccines much more broadly and deeply across different age groups and with different vaccine modalities and to probe the influence of genetics on these responses using monozygotic and dizygotic twins.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 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 1, 2009
Study Start Date : September 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

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
Participants will be randomized to receive either Fluzone® (intramuscular) or FluMist® (intranasal)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)

Biological: FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)

Group B: 18-30 yo identical twins
Participants to receive FluMist® (intranasal)
Biological: FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)

Group C: 18-30 yo fraternal twins
Participants to receive FluMist® (intranasal)
Biological: FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)

Group D: 40-49 yo identical twins
Participants to receive FluMist® (intranasal)
Biological: FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)

Group E: 40-49 yo fraternal twins
Participants to receive FluMist® (intranasal)
Biological: FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)

Group F: 70-100 yo twins
Participants to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)

Group G: 70-100 yo non-twins
Participants to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)




Primary Outcome Measures :
  1. Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine [ Time Frame: Day 0 to 28 ]

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

Other Outcome Measures:
  1. Lymphocyte Response to Influenza Immunization [ Time Frame: Day 6-28 post-immunization ]
    Compare lymphocyte responses at Days 6-14 and the lymphocyte and serology responses at Day 28 post-immunization following annual administration of the influenza vaccines



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 twin pairs), 18-30 years (identical or fraternal twin pairs), 40-49 years (identical or fraternal twin pairs) or 70-100 years (twin or non-twin adults).
  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. Negative urine pregnancy test for women of childbearing potential
  6. If the subject is female and of childbearing potential, she must use an acceptable method of contraception and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).

Exclusion Criteria:

  1. Prior vaccination with TIV or LAIV in Fall 2009
  2. Allergy to egg or egg products, or to vaccine components, including gentamicin, gelatin, arginine or MSG (for LAIV only), or thimerosal (TIV multidose vials only).
  3. Life-threatening reactions to previous influenza vaccinations
  4. Asthma (LAIV groups only)
  5. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  6. History of immune deficiency
  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, blood pressure >150/95 at screening, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  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 are permissible).
  11. Subjects in close contact with anyone who has a severely weakened immune system should not receive LAIV.
  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, Plavix, Aggrenox may be acceptable after review by investigator.
  16. Receipt of blood or blood products within the past 6 months
  17. Medical or psychiatric condition or occupational responsibilities that preclude subject 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): NCT01987349


Locations
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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
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Principal Investigator: Cornelia L Dekker, MD Stanford University
Principal Investigator: Mark M 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

Additional Information:
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: NCT01987349     History of Changes
Other Study ID Numbers: SU-17219-2009
2U19AI057229-06 ( U.S. NIH Grant/Contract )
First Posted: November 19, 2013    Key Record Dates
Results First Posted: May 12, 2017
Last Update Posted: May 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cornelia L. Dekker, Stanford University:
Influenza vaccines
healthy participants
immunity to influenza
identical twins
fraternal twins
non-twins
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