T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 2, 2010
NCT ID: NCT03022396
Last Updated: 2017-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
82 participants
INTERVENTIONAL
2010-09-30
2011-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group A: age 8-17 yo identical twins
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Group B: age 18-30 yo identical twins
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Group C: age 18-30 yo fraternal twins
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Group D: age 40 - 59 yo identical twins
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Group E: age 40 - 59 yo fraternal twins
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Group F: age 70 - 100 yo identical twins
Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
High Dose Fluzone® (intramuscular)
Licensed seasonal High dose trivalent inactivated influenza
Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Interventions
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High Dose Fluzone® (intramuscular)
Licensed seasonal High dose trivalent inactivated influenza
Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
8 Years
100 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Stanford University
OTHER
Responsible Party
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Cornelia L. Dekker
Professor, Pediatrics
Principal Investigators
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Cornelia Dekker, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Mark Davis, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Garry Nolan, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Ann Arvin, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Stephen Quake, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
References
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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.
Kay AW, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Holmes S, Blish CA. Enhanced natural killer-cell and T-cell responses to influenza A virus during pregnancy. Proc Natl Acad Sci U S A. 2014 Oct 7;111(40):14506-11. doi: 10.1073/pnas.1416569111. Epub 2014 Sep 22.
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.
Kay AW, Bayless NL, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Blish CA. Pregnancy Does Not Attenuate the Antibody or Plasmablast Response to Inactivated Influenza Vaccine. J Infect Dis. 2015 Sep 15;212(6):861-70. doi: 10.1093/infdis/jiv138. Epub 2015 Mar 4.
Rubelt F, Bolen CR, McGuire HM, Vander Heiden JA, Gadala-Maria D, Levin M, Euskirchen GM, Mamedov MR, Swan GE, Dekker CL, Cowell LG, Kleinstein SH, Davis MM. Individual heritable differences result in unique cell lymphocyte receptor repertoires of naive and antigen-experienced cells. Nat Commun. 2016 Mar 23;7:11112. doi: 10.1038/ncomms11112.
Horns F, Vollmers C, Croote D, Mackey SF, Swan GE, Dekker CL, Davis MM, Quake SR. Lineage tracing of human B cells reveals the in vivo landscape of human antibody class switching. Elife. 2016 Aug 2;5:e16578. doi: 10.7554/eLife.16578.
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.
de Bourcy CFA, Dekker CL, Davis MM, Nicolls MR, Quake SR. Dynamics of the human antibody repertoire after B cell depletion in systemic sclerosis. Sci Immunol. 2017 Sep 29;2(15):eaan8289. doi: 10.1126/sciimmunol.aan8289.
Other Identifiers
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SU-17219-2010
Identifier Type: -
Identifier Source: org_study_id
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