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

April 3, 2017 updated by: Cornelia L. Dekker, Stanford University

Protective Mechanisms Against a Pandemic Respiratory Virus: B- Cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 1, 2009

This study will compare influenza vaccine responses in monozygotic and dizygotic twins.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

72

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

    • 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

8 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A: age 8-17 yo identical twins
Participants will be randomized to receive either Fluzone® (intramuscular) or FluMist® (intranasal)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Other: Group B: 18-30 yo identical twins
Participants to receive FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Other: Group C: 18-30 yo fraternal twins
Participants to receive FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Other: Group D: 40-49 yo identical twins
Participants to receive FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Other: Group E: 40-49 yo fraternal twins
Participants to receive FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Other: Group F: 70-100 yo twins
Participants to receive Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
Other: Group G: 70-100 yo non-twins
Participants to receive Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine
Time Frame: Day 0 to 28
Day 0 to 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Related Adverse Events
Time Frame: Day 0 to 28 post-immunization
Day 0 to 28 post-immunization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 6-28 post-immunization

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Garry Nolan, PhD, Stanford University
  • Principal Investigator: Ann Arvin, MD, Stanford University

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.

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

September 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (Estimate)

November 19, 2013

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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