Influenza
Conditions
Keywords
Live, attenuated influenza vaccine, Children and young adults
Brief summary
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.
Detailed description
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
Interventions
BIOLOGICALFluMist®
Influenza Virus Vaccine Live, Intranasal Spray
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Otherwise healthy, ambulatory 2-8 years old (Group A) or 18-49 years old (Group B). 2. Willing to complete the informed consent process (including assent for minors 7 years old and above). 3. Availability for follow-up for the planned duration of the study at least 28 days after immunization. 4. Acceptable medical history by review of inclusion and
Exclusion criteria
and vital signs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants From Each Arm Who Received Influenza Vaccine | Day 0 to 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Related Adverse Events | Day 0 to 28 post-immunization |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 0 |
| Group B: 18-49 yo Healthy Non-twins Participants will be given seasonal LAIV, FluMist® .
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Group B: 18-49 yo Healthy Non-twins | Total |
|---|---|---|
| Age, Continuous | 28.07 years STANDARD_DEVIATION 8.09 | 28.07 years STANDARD_DEVIATION 8.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants |
| Region of Enrollment United States | 18 participants | 18 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 17 |
| serious Total, serious adverse events | 0 / 0 | 0 / 17 |
Outcome results
Primary
Number of Participants From Each Arm Who Received Influenza Vaccine
Time frame: Day 0 to 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: 2-8 yo Healthy Non-twins | Number of Participants From Each Arm Who Received Influenza Vaccine | 0 Participants |
| Group B: 18-49 yo Healthy Non-twins | Number of Participants From Each Arm Who Received Influenza Vaccine | 17 Participants |
Secondary
Number of Participants With Related Adverse Events
Time frame: Day 0 to 28 post-immunization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: 2-8 yo Healthy Non-twins | Number of Participants With Related Adverse Events | 0 Participants |
| Group B: 18-49 yo Healthy Non-twins | Number of Participants With Related Adverse Events | 0 Participants |