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

August 15, 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 2, 2010

This study will investigate response to influenza vaccines in monozygotic and dizygotic twins of different ages.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

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

Yes

Genders Eligible for Study

All

Description

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.

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
Individual twins to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Names:
  • TIV
Other: Group B: age 18-30 yo identical twins
Individual twins to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Names:
  • TIV
Other: Group C: age 18-30 yo fraternal twins
Individual twins to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Names:
  • TIV
Other: Group D: age 40 - 59 yo identical twins
Individual twins to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Names:
  • TIV
Other: Group E: age 40 - 59 yo fraternal twins
Individual twins to receive Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Names:
  • TIV
Other: Group F: age 70 - 100 yo identical twins
Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
Biological: Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Names:
  • TIV
Biological: High Dose Fluzone® (intramuscular)
Licensed seasonal High dose trivalent inactivated influenza
Other Names:
  • High Dose TIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 to 28

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Mark Davis, PhD, Stanford University
  • 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.

General Publications

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, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-17219-2010
  • 2U19AI057229-06 (U.S. NIH Grant/Contract)

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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