T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009
NCT ID: NCT01987349
Last Updated: 2017-05-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
72 participants
INTERVENTIONAL
2009-09-30
2010-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 2, 2010
NCT03022396
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013
NCT03023176
B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)
NCT03020498
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012
NCT03022435
B-cell Immunity to Influenza (SLVP017)- Year 1, 2009
NCT02133781
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A: age 8-17 yo identical twins
Participants will be randomized to receive either Fluzone® (intramuscular) or FluMist® (intranasal)
Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Group B: 18-30 yo identical twins
Participants to receive FluMist® (intranasal)
FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Group C: 18-30 yo fraternal twins
Participants to receive FluMist® (intranasal)
FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Group D: 40-49 yo identical twins
Participants to receive FluMist® (intranasal)
FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Group E: 40-49 yo fraternal twins
Participants to receive FluMist® (intranasal)
FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Group F: 70-100 yo twins
Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
Group G: 70-100 yo non-twins
Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
FluMist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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. 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
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.
8 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cornelia L. Dekker
Professor, Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cornelia L Dekker, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Mark M 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
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University School of Medicine
Stanford, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SU-17219-2009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.