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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 compare influenza vaccine responses in monozygotic and dizygotic twins.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: age 8-17 yo identical twins | Other | Participants will be randomized to receive either Fluzone® (intramuscular) or FluMist® (intranasal) |
|
| Group B: 18-30 yo identical twins | Other | Participants to receive FluMist® (intranasal) |
|
| Group C: 18-30 yo fraternal twins | Other | Participants to receive FluMist® (intranasal) |
|
| Group D: 40-49 yo identical twins | Other | Participants to receive FluMist® (intranasal) |
|
| Group E: 40-49 yo fraternal twins | Other | Participants to receive FluMist® (intranasal) |
|
| Group F: 70-100 yo twins | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone® (intramuscular) | Biological | Licensed seasonal trivalent inactivated influenza vaccine (IIV3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine | Day 0 to 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related Adverse Events | Day 0 to 28 post-immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphocyte Response to Influenza 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 | Day 6-28 post-immunization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| 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. | |
| 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. |
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Numbers listed in the tables reflect individual twins and not twin pairs.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Age 8-17 yo Identical Twins | Participants will be randomized to receive Fluzone® (intramuscular) |
| FG001 | Group A: Age 8-17yo Identical Twins | Participants will be randomized to receive FluMist® (intranasal) |
| FG002 | Group B: Age 18-30 yo Identical Twins | Participants to receive FluMist® (intranasal) |
| FG003 | Group C: Age 18-30 yo Fraternal Twins | Participants to receive FluMist® (intranasal) |
| FG004 | Group D: Age 40-49 yo Identical Twins | Participants to receive FluMist® (intranasal) |
| FG005 | Group E: Age 40-49 yo Fraternal Twins | Participants to receive FluMist® (intranasal) |
| FG006 | Group F: 70-100 yo Identical Twins | Participants to receive Fluzone® (intramuscular) |
| FG007 | Group G: 70-100 yo Nontwins | Participants to receive Fluzone® (intramuscular) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants between the ages of 8 - 100 years old.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Age 8-17 yo Identical Twins (Fluzone) | Participants will be randomized to receive Fluzone® (intramuscular) |
| BG001 | Group A: Age 8-17 yo Identical Twins (FluMist) | Participants will be randomized to receive FluMist® (intranasal) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Participants From Each Arm Who Received Influenza Vaccine Vaccine | Posted | Count of Participants | Participants | Day 0 to 28 |
|
Day 0 to Day 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 (Fluzone) | Participants will be randomized to receive Fluzone® (intramuscular) |
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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 |
| C000613429 | FluMist |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Participants to receive Fluzone® (intramuscular)
|
| Group G: 70-100 yo non-twins | Other | Participants to receive Fluzone® (intramuscular) |
|
| FluMist® (intranasal) | Biological | Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3) |
|
| 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. |
| BG002 | Group B: Age 18-30 yo Identical Twins | Participants to receive FluMist® (intranasal) |
| BG003 | Group C: Age 18-30 yo Fraternal Twins | Participants to receive FluMist® (intranasal) |
| BG004 | Group D: Age 40-49 yo Identical Twins | Participants to receive FluMist® (intranasal) |
| BG005 | Group E: Age 40-49 yo Fraternal Twins | Participants to receive FluMist® (intranasal) |
| BG006 | Group F: 70-100 yo Identical Twins | Participants to receive Fluzone® (intramuscular) |
| BG007 | Group G: 70-100 yo Nontwins | Participants to receive Fluzone® (intramuscular) |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants to receive FluMist® (intranasal) FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3) |
| OG003 | Group C: 18-30 yo Fraternal Twins | Participants to receive Flumist® (intranasal) Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3) |
| OG004 | Group D: 40-49 yo Identical Twins | Participants to receive Flumist® (intranasal) Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3) |
| OG005 | Group E: 40-49 yo Fraternal Twins | Participants to receive Flumist® (intranasal) Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3) |
| OG006 | Group F: 70-100 yo Twins | Participants to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3) |
| OG007 | Group G: 70-100 yo Non-twins | Participants to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3) |
|
|
| Secondary | Number of Participants With Related Adverse Events | Posted | Count of Participants | Participants | Day 0 to 28 post-immunization |
|
|
|
| Other Pre-specified | Lymphocyte Response to Influenza 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 | Not Posted | Day 6-28 post-immunization | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Group A: Age 8-17 yo Identical Twins (Flumist) | Participants will be randomized to receive Flumist® (intranasal) | 0 | 6 | 0 | 6 |
| EG002 | Group B: 18-30 yo Identical Twin Pairs | Participants to receive Flumist® (intranasal) Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3) | 0 | 8 | 0 | 8 |
| EG003 | Group C: 18-30 yo Fraternal Twins | Participants to receive Flumist® (intranasal) Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3) | 0 | 6 | 0 | 6 |
| EG004 | Group D: 40-49 yo Identical Twins | Participants to receive Flumist® (intranasal) Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3) | 0 | 6 | 0 | 6 |
| EG005 | Group E: 40-49 yo Fraternal Twins | Participants to receive Flumist® (intranasal) Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3) | 0 | 6 | 0 | 6 |
| EG006 | Group F: 70-100 yo Twins | Participants to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3) | 0 | 10 | 0 | 10 |
| EG007 | Group G: 70-100 yo Non-twins | Participants to receive Fluzone® (intramuscular) Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3) | 0 | 24 | 0 | 24 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D007267 |
| Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |