InfluenzaPhase 4FLU-TonsilNCT03884296
Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood
A Phase 4 study testing FluMist in people with Influenza, run by Stanford University at 1 site in United States.
Trial summary
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to a nasal flu immunization in tonsillar tissue compared to what can be measured in the blood. Read more about this study
- Who is it for?
- Ages 2 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FluMist
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 17 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 2-49-year-old male and female patients undergoing tonsillectomy for obstructive sleep apnea or other non-infectious indication.
- Willing and able to complete the informed consent process
- Availability for follow-up for the planned duration of the study
- Acceptable medical history by review of inclusion/exclusion criteria
Who cannot join
- Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
- Life-threatening reactions to previous influenza vaccinations
- Asthma (contraindication for receipt of LAIV4)
- Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, arginine or MSG.
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
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- Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
- Hospitalization in the past year for congestive heart failure or emphysema.
- Chronic Hepatitis B or C.
- Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
- Participants in close contact with anyone who has a severely weakened immune system
- Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol.
- Receipt of blood or blood products within the past 6 months or planned used during the study.
- A medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last study visit (~ 14 days after study vaccination)
- Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 14 days after study enrollment)
- Need for allergy immunization (that cannot be postponed) until after the last study visit.
- History of Guillain-Barre# syndrome
- Pregnant or breastfeeding woman
- Use of investigational agents within 30 days prior to enrollment or planned use during the study.
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or donation of platelets within 2 weeks of enrollment or planned donation prior to completion of the last visit.
- Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center, Lane building L134
Stanford, California, 94305
About this study
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to a nasal flu immunization in tonsillar tissue compared to what can be measured in the blood.
Read the detailed description
This is a Phase IV study of licensed influenza vaccines with up to 50 male and female volunteers, 2-49 years of age. Volunteers were patients undergoing tonsillectomy for treatment of obstructive sleep apnea (OSA) or other non-infectious indication as part of their routine medical care.
The investigator intends to collect blood and lymphoid tissues routinely discarded during surgery from adults and children after routine seasonal live attenuated influenza vaccination (LAIV) to determine how immune memory develops at the actual site of infection, and how immunization may alter this process.
The first research study visit will take place approximately 3-14 days prior to the scheduled date of tonsillectomy surgery. During this visit, 20 mL blood sample will be obtained and participants will receive FluMist (intranasal, quadrivalent, live-attenuated influenza vaccine). This is one of the routinely available and recommended vaccines for the age groups included in this study.
The second study visit will take place on the same day of the scheduled surgery for the tonsillectomy. Another blood sample (maximum volume of 20 mL) will be collected along with the discarded tonsillar tissue. Blood and tissues will be sent to the lab.
- Conditions
- Influenza
- Being tested
- FluMist
- Keywords
- Obstructive sleep apnea, Quadrivalent live, attenuated influenza vaccine, Flumist
- Medical subject headings
- Influenza, Human, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluMistBiological
Quadrivalent, live, attenuated influenza vaccine, intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| Study Phase | Other | Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy. Receives: Biological: FluMist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma HAI titer
HAI titer measures imune response to influenza vaccination
Measured: Day 3-14 after receipt of LAIV
Number of Participants With Related Adverse Events
We will capture AEs to LAIV
Measured: Day 0 to 14 post-immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start15 Apr 2019
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Why it stopped: Not feasible to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Philip Grant, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884296
- Sponsor's protocol ID
- 50122
- Other IDs
- 5U19AI057229-15
- Acronym
- FLU-Tonsil
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2019
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Live Attenuated Influenza Vaccine in Tonsillar Tissues and Blood
- ClinicalTrials.gov ID
- NCT03884296
- Acronym / sponsor ID
- FLU-Tonsil / 50122
- Conditions
- Influenza
- Keywords
- Obstructive sleep apnea, Quadrivalent live, attenuated influenza vaccine, Flumist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not feasible to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to a nasal flu immunization in tonsillar tissue compared to what can be measured in the blood.
Detailed description
This is a Phase IV study of licensed influenza vaccines with up to 50 male and female volunteers, 2-49 years of age. Volunteers were patients undergoing tonsillectomy for treatment of obstructive sleep apnea (OSA) or other non-infectious indication as part of their routine medical care.
The investigator intends to collect blood and lymphoid tissues routinely discarded during surgery from adults and children after routine seasonal live attenuated influenza vaccination (LAIV) to determine how immune memory develops at the actual site of infection, and how immunization may alter this process.
The first research study visit will take place approximately 3-14 days prior to the scheduled date of tonsillectomy surgery. During this visit, 20 mL blood sample will be obtained and participants will receive FluMist (intranasal, quadrivalent, live-attenuated influenza vaccine). This is one of the routinely available and recommended vaccines for the age groups included in this study.
The second study visit will take place on the same day of the scheduled surgery for the tonsillectomy. Another blood sample (maximum volume of 20 mL) will be collected along with the discarded tonsillar tissue. Blood and tissues will be sent to the lab.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Phase | Other | Biological: FluMistParticipants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy. |
Who may qualify
- Ages
- 2 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 2-49-year-old male and female patients undergoing tonsillectomy for obstructive sleep apnea or other non-infectious indication.
- Willing and able to complete the informed consent process
- Availability for follow-up for the planned duration of the study
- Acceptable medical history by review of inclusion/exclusion criteria
Key exclusion criteria (25 listed)
- Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
- Life-threatening reactions to previous influenza vaccinations
- Asthma (contraindication for receipt of LAIV4)
- Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, arginine or MSG.
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluMistQuadrivalent, live, attenuated influenza vaccine, intranasal spray | Biological | Study Phase |
Primary outcome
Plasma HAI titer
Time frame: Day 3-14 after receipt of LAIV
HAI titer measures imune response to influenza vaccination
Number of Participants With Related Adverse Events
Time frame: Day 0 to 14 post-immunization
We will capture AEs to LAIV
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FluMist in people with Influenza, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma HAI titer (time frame: Day 3-14 after receipt of LAIV). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.