Influenza
Conditions
Keywords
Quadrivalent inactivated influenza vaccine, Quadrivalent live, attenuated influenza vaccine, Adults with obstructive sleep apnea
Brief summary
The investigators collected blood and lymphoid tissues routinely discarded during surgery from adults after a routine seasonal influenza vaccination to determine how immune memory develops at the actual site of infection, and how immunization may alter this process.
Detailed description
This is a Phase IV study of licensed influenza vaccines with up to 30 male and female adults, 18-49 years of age that was halted due to the recommendation that live, attenuated influenza vaccine (LAIV) not be used as a seasonal flu vaccine. Volunteers were patients undergoing tonsillectomy for treatment of obstructive sleep apnea (OSA). In the initial pilot phase of the study, up to 3 volunteers will be enrolled and will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4) given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy. Enrollment of the remaining study volunteers into the main portion of the study will begin once the initial pilot phase is completed. All of the remaining study volunteers will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4) intranasally. The second study visit for all volunteers will occur at the time of the volunteer's tonsillectomy surgery, 3-14 days after Visit 01. A member of the surgical team will collect a 20 mL blood sample and a sample of the resected tonsil tissue that would otherwise be discarded to be distributed to the lab.
Interventions
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
3-5 participants will receive quadrivalent inactivated flu (IIV4) vaccine as a pilot study to establish protocols for immune cell isolation. Once the pilot study ends, all new participants will receive live, attenuated influenza vaccine and IIV4 will no longer be utilitzed.
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Generally healthy 18-49 year old male and female patients undergoing tonsillectomy for obstructive sleep apnea. 2. Willing to complete the informed consent process 3. Availability for follow-up for the planned duration of the study 4. Acceptable medical history by review of inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Received Influenza Vaccine | Day 0 |
| Number of Participants With Related Adverse Events | Day 0 to 14 post-immunization |
Participant flow
Recruitment details
The study was halted after the IIV pilot phase because the LAIV vaccine for the study phase was not recommended for use by ACIP so no participants enrolled in the LAIV study phase.
Participants by arm
| Arm | Count |
|---|---|
| Pilot Phase (IIV4) Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular | 3 |
| Study Phase (LAIV4) Participants will be given quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | Pilot Phase (IIV4) | Total |
|---|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 7.93 | 32 years STANDARD_DEVIATION 7.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 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 | 2 Participants | 2 Participants |
| Region of Enrollment United States | 3 participants | 3 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
Number of Participants Who Received Influenza Vaccine
Time frame: Day 0
Population: Study halted after Pilot Phase
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Phase | Number of Participants Who Received Influenza Vaccine | 3 Participants |
| Study Phase | Number of Participants Who Received Influenza Vaccine | 0 Participants |
Primary
Number of Participants With Related Adverse Events
Time frame: Day 0 to 14 post-immunization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Phase | Number of Participants With Related Adverse Events | 0 Participants |
| Study Phase | Number of Participants With Related Adverse Events | 0 Participants |