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| ID | Type | Description | Link |
|---|---|---|---|
| U19AI057229-07 | 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 of the study is to investigate and compare the human immune response in epithelial cells of the nasopharyngeal mucosa and in blood to live, attenuated influenza vaccine (LAIV) in adults and in children.
The objective of the protocol is to investigate the human innate and adaptive immune responses in blood (only for adults) and nasopharyngeal mucosa resident cells to the live, attenuated influenza vaccine (LAIV) in both adults and children. The investigators hope to learn how the upper respiratory tract (URT) epithelial cells, the primary target of respiratory viruses, and the B cells and T cells, two major components of the immune system, respond to the influenza vaccine.
The volunteers will be enrolled in two age groups:
Group A: Up to 12 healthy non-twin volunteers, 2-8 years old, will be given seasonal LAIV. Each volunteer will complete a total of 3 visits. Volunteers will be divided in 2 sub-groups A-1 (n=6) and A-2 (n= 6) in order to collect nasopharyngeal swabs on different schedules (Day 1 or Day 2). Volunteers will be assigned to these sub-groups based on convenience sampling. Both sub-groups will complete the Day 0 and Day 28 visits and one visit at either Day 1 or Day 2 post-immunization. Specimens will include nasopharyngeal swabs collected at Day 1 for Sub-group A1 and Day 2 for Sub-group A-2, and Day 28 for both sub-groups. No blood samples will be collected in this age group.
Children with no prior influenza vaccine history will receive a second dose of vaccine (LAIV) at least 28 days after the first study dose, according to the ACIP guidelines.
Group B: Up to 18 healthy non-twin volunteers, 18-49 yrs old, will be given seasonal LAIV vaccine. Each volunteer will complete a total of 5 visits. Volunteers will be divided into 3 sub-groups B-1, B-2 and B-3 in order to collect nasopharyngeal swabs and blood specimens on different schedules (Day 0-6 hrs, Day 1 or Day 2). Volunteers will be assigned to these sub-groups based on convenience sampling. All sub-groups will complete visits at Day -7, Day 0 pre-immunization, Day 7 and Day 28 and 1 additional time point: Sub-group B-1 at Day 0, 6 hours post-immunization, Sub-group B-2 at Day 1 and Sub-group B-3 at Day 2. A nasopharyngeal swab will be collected at each visit except for Day 0 (baseline) and Day 7. A blood sample will be collected at each visit except Day -7
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: 2-8 yo healthy non-twins | Other | Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose. |
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| Group B: 18-49 yo healthy non-twins | Other | Participants will be given seasonal LAIV, FluMist® . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluMist® | Biological | Influenza Virus Vaccine Live, Intranasal Spray |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants From Each Arm 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 |
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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 |
| Xiaosong He, PhD | Stanford University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: 2-8 yo Healthy Non-twins | Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose. FluMist®: Influenza Virus Vaccine Live, Intranasal Spray |
| FG001 | Group B: 18-49 yo Healthy Non-twins | Participants will be given seasonal LAIV, FluMist® . FluMist®: Influenza Virus Vaccine Live, Intranasal Spray |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: 2-8 yo Healthy Non-twins | Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose. FluMist®: Influenza Virus Vaccine Live, Intranasal Spray |
| BG001 |
| 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, 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 From Each Arm Who Received Influenza Vaccine | Posted | Count of Participants | Participants | Day 0 to 28 |
|
Day 0 to 28
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: 2-8 yo Healthy Non-twins | Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose. FluMist®: Influenza Virus Vaccine Live, Intranasal Spray |
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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 |
|---|---|
| C000613429 | FluMist |
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| Group B: 18-49 yo Healthy Non-twins |
Participants will be given seasonal LAIV, FluMist® . FluMist®: Influenza Virus Vaccine Live, Intranasal Spray |
| BG002 | Total | Total of all reporting groups |
| years |
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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 | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Number of Participants With Related Adverse Events | Posted | Count of Participants | Participants | Day 0 to 28 post-immunization |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group B: 18-49 yo Healthy Non-twins | Participants will be given seasonal LAIV, FluMist® . FluMist®: Influenza Virus Vaccine Live, Intranasal Spray | 0 | 17 | 0 | 17 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |