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| ID | Type | Description | Link |
|---|---|---|---|
| U19AI057229-06 | 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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The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in healthy young adults by vaccinating participants and obtaining blood samples at designated time points before and after vaccination.
This is an exploratory study using a strategy that has not been previously employed to investigate B-cell responses. Investigators will collect blood samples from the volunteers at a higher frequency than in the two previous flu seasons to better define the dynamic response to vaccination. The objective is to compare the Ig gene repertoire before and after vaccination by deep sequencing PBMC and proteomic analysis of antibody CDR3 regions at 10 different time points before and after immunization.
This is a Phase IV study of healthy adults who are given standard TIV off-season. 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 at Day -5, Day -3 and Day 0 prior to immunization, and at Days 1, 4, 7, 9, 11, 28 and 180 post-immunization. Volunteers will be vaccine-naïve for the 2010-2011 and 2011-2012 seasonal influenza vaccines. All participants will receive a single dose of the current seasonal influenza vaccine by intramuscular (IM) injection at Day 0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2011-2012 Fluzone IIV3 (IM) | Other | Seasonal trivalent flu vaccine: NDC No 49281-011-50 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2011-2012 Fluzone IIV3 (IM) | Biological | 2011-2012 Fluzone IIV3 vaccine delivered intramuscularly (IM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received Influenza Vaccine | Day 0 to 180 post-immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related Adverse Events | Day 0 to 180 post-immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Proteomic Analysis of Antibody CDR3 Regions at 10 Different Time Points Before and After Immunization. | Proteomic analysis: Identification, production, and characterization of Influenza A specific antibodies and their CDRH3 amino-acid sequences. | Day -5 to 180 post-immunization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia Dekker, MD | Stanford University | Principal Investigator |
| Stephen Quake, PhD | Stanford University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27820605 | Background | Lee J, Boutz DR, Chromikova V, Joyce MG, Vollmers C, Leung K, Horton AP, DeKosky BJ, Lee CH, Lavinder JJ, Murrin EM, Chrysostomou C, Hoi KH, Tsybovsky Y, Thomas PV, Druz A, Zhang B, Zhang Y, Wang L, Kong WP, Park D, Popova LI, Dekker CL, Davis MM, Carter CE, Ross TM, Ellington AD, Wilson PC, Marcotte EM, Mascola JR, Ippolito GC, Krammer F, Quake SR, Kwong PD, Georgiou G. Molecular-level analysis of the serum antibody repertoire in young adults before and after seasonal influenza vaccination. Nat Med. 2016 Dec;22(12):1456-1464. doi: 10.1038/nm.4224. Epub 2016 Nov 7. | |
| 30622180 |
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The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique ID code and the volunteer identity (except for age) will not be disclosed.
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During spring and early summer (prior to June 30) of 2012, 11 participants were consented to participate. One participant was found to be ineligible and was therefore withdrawn prior to any interventions.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2011-2012 Fluzone IIV3 (IM) | 2011-2012 Fluzone IIV3 NDC No 49281-011-50 2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants between the ages of 18-30
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| ID | Title | Description |
|---|---|---|
| BG000 | 2011-2012 Fluzone IIV3 (IM) | 2011-2012 Fluzone IIV3 NDC No 49281-011-50 2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 Who Received Influenza Vaccine | 10 participants received the 2011-2012 Fluzone IIV3 vaccine | Posted | Count of Participants | Participants | Day 0 to 180 post-immunization |
|
|
180 days post immunization
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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 | 2011-2012 Fluzone IIV3 (IM) | 2011-2012 Fluzone IIV3 NDC No 49281-011-50 2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Pain in lumbosacral area |
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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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| Derived |
| Horns F, Vollmers C, Dekker CL, Quake SR. Signatures of selection in the human antibody repertoire: Selective sweeps, competing subclones, and neutral drift. Proc Natl Acad Sci U S A. 2019 Jan 22;116(4):1261-1266. doi: 10.1073/pnas.1814213116. Epub 2019 Jan 8. |
| 28096374 | Derived | de Bourcy CF, Angel CJ, Vollmers C, Dekker CL, Davis MM, Quake SR. Phylogenetic analysis of the human antibody repertoire reveals quantitative signatures of immune senescence and aging. Proc Natl Acad Sci U S A. 2017 Jan 31;114(5):1105-1110. doi: 10.1073/pnas.1617959114. Epub 2017 Jan 17. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Number of Participants With Related Adverse Events | Number of participants with related adverse events up to 180 days post immunization | Posted | Count of Participants | Participants | Day 0 to 180 post-immunization |
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|
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| Other Pre-specified | Proteomic Analysis of Antibody CDR3 Regions at 10 Different Time Points Before and After Immunization. | Proteomic analysis: Identification, production, and characterization of Influenza A specific antibodies and their CDRH3 amino-acid sequences. | Not Posted | Day -5 to 180 post-immunization | Participants |
| 0 |
| 10 |
| 3 |
| 10 |
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| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
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| Abrasion LT upper leg | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Bike Accident |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |