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| ID | Type | Description | Link |
|---|---|---|---|
| 2U19AI057229-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study will investigate response to influenza vaccines in monozygotic and dizygotic twins of different ages.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: age 8-17 yo identical twins | Other | Individual twins to receive Fluzone® (intramuscular) |
|
| Group B: age 18-30 yo identical twins | Other | Individual twins to receive Fluzone® (intramuscular) |
|
| Group C: age 18-30 yo fraternal twins | Other | Individual twins to receive Fluzone® (intramuscular) |
|
| Group D: age 40 - 59 yo identical twins | Other | Individual twins to receive Fluzone® (intramuscular) |
|
| Group E: age 40 - 59 yo fraternal twins | Other | Individual twins to receive Fluzone® (intramuscular) |
|
| Group F: age 70 - 100 yo identical twins | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Fluzone® (intramuscular) | Biological | Licensed seasonal High dose trivalent inactivated influenza |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Individual Twins Who Received Influenza Vaccine | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Individual Twins With Related Adverse Events | Day 0 to 28 post-immunization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia Dekker, MD | Stanford University | Principal Investigator |
| Mark 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 | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24154599 | Background | 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. | |
| 25246558 | Background | 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. |
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All numbers of participants reflect an individual participant, not a twin pair. All enrollment numbers reflect the number of participants, not the number of twin pairs.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Age 8-17 yo Identical Twins | Individual Twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| FG001 | Group B: Age 18-30 yo Identical Twins | Individual Twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| FG002 | Group C: Age 18-30 yo Fraternal Twins | Individual Twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| FG003 | Group D: Age 40 - 59 yo Identical Twins | Individual Twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| FG004 | Group E: Age 40 - 59 yo Fraternal Twins | Individual Twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| FG005 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All numbers reflect the number of individual participants, not the number of twin pairs. Ie, in Group A there were 16 participants who were part of 8 twin pairs.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Age 8-17 yo Identical Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| BG001 | Group B: Age 18-30 yo Identical Twins |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Individual Twins Who Received Influenza Vaccine | 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. | 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. | Posted | Count of Participants | Participants | Day 0 to 28 |
|
Day 0 to 28 of study participation
Clinical Assessment performed at each visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Age 8-17 yo Identical Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Cornelia Dekker | Stanford University School of Medicine, Dept. of Pediatrics | 650-724-4437 | cdekker@stanford.edu |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D007273 | Injections, Intramuscular |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
|
| Fluzone® (intramuscular) | Biological | Licensed seasonal trivalent inactivated influenza |
|
|
| 25594173 | Background | 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. |
| 25740957 | Background | 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. |
| 27005435 | Background | 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. |
| 27481325 | Background | 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. |
| 29706550 | Derived | 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. |
| 28963118 | Derived | 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. |
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
| BG002 | Group C: Age 18-30 yo Fraternal Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| BG003 | Group D: Age 40 - 59 yo Identical Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| BG004 | Group E: Age 40 - 59 yo Fraternal Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| BG005 | Group F: Age 70 - 100 yo 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 |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | The Race is inconsistent in Group D because identical twins self reported differently from each other. One identical twin reported Hispanic and American Indian and the other identical twin said Hispanic and Caucasian. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
| OG002 | Group C: Age 18-30 yo Fraternal Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| OG003 | Group D: Age 40 - 59 yo Identical Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| OG004 | Group E: Age 40 - 59 yo Fraternal Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza |
| OG005 | Group F: Age 70 - 100 yo 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 |
|
|
| Secondary | Number of Individual Twins With Related Adverse Events | Posted | Count of Participants | Participants | Day 0 to 28 post-immunization |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Group B: Age 18-30 yo Identical Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Group C: Age 18-30 yo Fraternal Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Group D: Age 40 - 59 yo Identical Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza | 0 | 20 | 0 | 20 | 0 | 20 |
| EG004 | Group E: Age 40 - 59 yo Fraternal Twins | Individual twins to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza | 0 | 14 | 0 | 14 | 0 | 14 |
| EG005 | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D007267 |
| Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |