- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01987349
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
Status
Completed
Conditions
Intervention / Treatment
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
-
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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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:
- 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).
- Willing to complete the informed consent process.
- Availability for follow-up for the planned duration of the study at least 28 days after immunization.
- Acceptable medical history and vital signs.
- Negative urine pregnancy test for women of childbearing potential
- 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:
- Prior vaccination with TIV or LAIV in Fall 2009
- 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).
- Life-threatening reactions to previous influenza vaccinations
- Asthma (LAIV groups only)
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immune deficiency
- 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.
- Hospitalization in the past year for congestive heart failure or emphysema.
- Chronic Hepatitis B or C
- Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays are permissible).
- Subjects in close contact with anyone who has a severely weakened immune system should not receive LAIV.
- 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).
- 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.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- 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.
- Receipt of blood or blood products within the past 6 months
- Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
- Inactivated vaccine 14 days prior to vaccination
- Live, attenuated vaccine within 60 days of vaccination
- History of Guillain-Barre Syndrome
- Pregnant or lactating woman
- Use of investigational agents within 30 days prior to enrollment
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
- 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)
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Other: Group B: 18-30 yo identical twins
Participants to receive FluMist® (intranasal)
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Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
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Other: Group C: 18-30 yo fraternal twins
Participants to receive FluMist® (intranasal)
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Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
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Other: Group D: 40-49 yo identical twins
Participants to receive FluMist® (intranasal)
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Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
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Other: Group E: 40-49 yo fraternal twins
Participants to receive FluMist® (intranasal)
|
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
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Other: Group F: 70-100 yo twins
Participants to receive Fluzone® (intramuscular)
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Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
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Other: Group G: 70-100 yo non-twins
Participants to receive Fluzone® (intramuscular)
|
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
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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
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Day 0 to 28
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Related Adverse Events
Time Frame: Day 0 to 28 post-immunization
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Day 0 to 28 post-immunization
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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
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Day 6-28 post-immunization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- Horowitz A, Strauss-Albee DM, Leipold M, Kubo J, Nemat-Gorgani N, Dogan OC, Dekker CL, Mackey S, Maecker H, Swan GE, Davis MM, Norman PJ, Guethlein LA, Desai M, Parham P, Blish CA. Genetic and environmental determinants of human NK cell diversity revealed by mass cytometry. Sci Transl Med. 2013 Oct 23;5(208):208ra145. doi: 10.1126/scitranslmed.3006702.
- Brodin P, Jojic V, Gao T, Bhattacharya S, Angel CJ, Furman D, Shen-Orr S, Dekker CL, Swan GE, Butte AJ, Maecker HT, Davis MM. Variation in the human immune system is largely driven by non-heritable influences. Cell. 2015 Jan 15;160(1-2):37-47. doi: 10.1016/j.cell.2014.12.020.
- Cheung P, Vallania F, Warsinske HC, Donato M, Schaffert S, Chang SE, Dvorak M, Dekker CL, Davis MM, Utz PJ, Khatri P, Kuo AJ. Single-Cell Chromatin Modification Profiling Reveals Increased Epigenetic Variations with Aging. Cell. 2018 May 31;173(6):1385-1397.e14. doi: 10.1016/j.cell.2018.03.079. Epub 2018 Apr 26.
Helpful Links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-17219-2009
- 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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