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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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In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different influenza vaccines given to identical twins, vaccine-naive young adults and elderly participants.
This is an exploratory study of healthy children and adults who are given either standard trivalent, inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV). There are no exclusions for gender, ethnicity or race. Following confirmation of written informed consent, baseline blood samples will be drawn from all study participants prior to immunization. The volunteers enrolled in any the three groups (A,B,C) cannot have been immunized with previous year's seasonal influenza vaccine. The identical twins in Groups A will be randomized to each receive a different vaccine (TIV or LAIV) than their twin. The non-twin children in Group B will also be randomly assigned to receive either TIV or LAIV. Non-twin elderly adults in Group C will be given standard TIV. All participants will receive a single dose of their assigned influenza vaccine, either by intramuscular (IM) injection (TIV) or intranasal application (LAIV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: 8-17 yo identical twins | Other | Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair |
|
| Group B: 8-30 yo non-twin | Other | Group B: 8-30 years old non-twin individuals randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) |
|
| Group C: 70-100 yo non-twin | Other | Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone | Biological | Influenza Virus Vaccine Suspension for Intramuscular Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received Influenza 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 |
|---|---|---|
| Investigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses. | Day 0 to 28 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia Dekker, MD | Stanford University | Principal Investigator |
| Harry Greenberg, MD | Stanford University | Principal Investigator |
| Stephen Quake, PhD | Stanford University | Principal Investigator |
| Xiaosong He, PhD | Stanford University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24676204 | Background | Sasaki S, Holmes TH, Albrecht RA, Garcia-Sastre A, Dekker CL, He XS, Greenberg HB. Distinct cross-reactive B-cell responses to live attenuated and inactivated influenza vaccines. J Infect Dis. 2014 Sep 15;210(6):865-74. doi: 10.1093/infdis/jiu190. Epub 2014 Mar 27. | |
| 25336731 | Background | He XS, Holmes TH, Sanyal M, Albrecht RA, Garcia-Sastre A, Dekker CL, Davis MM, Greenberg HB. Distinct patterns of B-cell activation and priming by natural influenza virus infection versus inactivated influenza vaccination. J Infect Dis. 2015 Apr 1;211(7):1051-9. doi: 10.1093/infdis/jiu580. Epub 2014 Oct 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: 8-17 yo Identical Twins | Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray |
| FG001 | Group B: 8-30 yo Non-twin | Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray |
| FG002 | Group C: 70-100 yo Non-twin | Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV)) Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: 8-17 yo Identical Twins | Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray |
| 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 Participants Who Received Influenza 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: 8-17 yo Identical Twins | Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Light headedness | Nervous system disorders | Systematic Assessment | Reported after the blood draw. |
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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 |
| C000613429 | FluMist |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| FluMist | Biological | Influenza Virus Vaccine Live, Intranasal Intranasal Spray |
|
| 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. |
| 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. |
| BG001 |
| Group B: 8-30 yo Non-twin |
Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray |
| BG002 | Group C: 70-100 yo Non-twin | Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV)) Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Group C: 70-100 yo Non-twin | Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV)) Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection |
|
|
| Secondary | Number of Participants With Related Adverse Events | Posted | Count of Participants | Participants | Day 0 to 28 post-immunization |
|
|
|
| Other Pre-specified | Investigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses. | Not Posted | Day 0 to 28 | Participants |
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Group B: 8-30 yo Non-twin | Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray | 0 | 38 | 1 | 38 |
| EG002 | Group C: 70-100 yo Non-twin | Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV)) Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection | 0 | 36 | 1 | 36 |
|
| Syncope | Nervous system disorders | Systematic Assessment | Reported during blood draw |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |