T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009
Protective Mechanisms Against a Pandemic Respiratory Virus: B- Cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 1, 2009
2 other identifiers
interventional
72
1 country
1
Brief Summary
This study will compare influenza vaccine responses in monozygotic and dizygotic twins.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 24, 2013
CompletedFirst Posted
Study publicly available on registry
November 19, 2013
CompletedResults Posted
Study results publicly available
May 12, 2017
CompletedMay 12, 2017
April 1, 2017
4 months
October 24, 2013
January 11, 2017
April 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine
Day 0 to 28
Secondary Outcomes (1)
Number of Participants With Related Adverse Events
Day 0 to 28 post-immunization
Other Outcomes (1)
Lymphocyte Response to Influenza Immunization
Day 6-28 post-immunization
Study Arms (7)
Group A: age 8-17 yo identical twins
OTHERParticipants will be randomized to receive either Fluzone® (intramuscular) or FluMist® (intranasal)
Group B: 18-30 yo identical twins
OTHERParticipants to receive FluMist® (intranasal)
Group C: 18-30 yo fraternal twins
OTHERParticipants to receive FluMist® (intranasal)
Group D: 40-49 yo identical twins
OTHERParticipants to receive FluMist® (intranasal)
Group E: 40-49 yo fraternal twins
OTHERParticipants to receive FluMist® (intranasal)
Group F: 70-100 yo twins
OTHERParticipants to receive Fluzone® (intramuscular)
Group G: 70-100 yo non-twins
OTHERParticipants to receive Fluzone® (intramuscular)
Interventions
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (3)
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.
PMID: 24154599BACKGROUNDBrodin 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.
PMID: 25594173BACKGROUNDCheung 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.
PMID: 29706550DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Cornelia Dekker
- Organization
- Stanford University School of Medicine, Dept. of Pediatrics
Study Officials
- PRINCIPAL INVESTIGATOR
Cornelia L Dekker, MD
Stanford University
- PRINCIPAL INVESTIGATOR
Mark M Davis, PhD
Stanford University
- PRINCIPAL INVESTIGATOR
Garry Nolan, PhD
Stanford University
- PRINCIPAL INVESTIGATOR
Ann Arvin, MD
Stanford University
- PRINCIPAL INVESTIGATOR
Stephen Quake, PhD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Pediatrics
Study Record Dates
First Submitted
October 24, 2013
First Posted
November 19, 2013
Study Start
September 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
May 12, 2017
Results First Posted
May 12, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share