InfluenzaPhase 4NCT03023709
Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers (SLVP032)
A Phase 4 study testing Fluzone® and FluMist® in people with Influenza, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluzone® and FluMist®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy 18-49 year old male and female patients undergoing tonsillectomy for obstructive sleep apnea.
- Willing 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) for study volunteers; not a contraindication for enrolling as a pilot phase volunteer receiving IIV4.
- Allergy to egg or egg products or to vaccine components (including gentamicin, gelatin, arginine or MSG for participants receiving LAIV4).
- 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 who care for severely immunosuppressed persons that require a protective environment should not receive LAIV, or should avoid contact with such persons for 7 days after receipt, given the theoretical risk for transmission of the live attenuated vaccine virus to close contacts. [If yes, may be ineligible]
- 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.
- Has taken an influenza antiviral medication within 48 hours prior to study vaccination [For volunteers receiving LAIV; If yes, may not eligible if unable to schedule at an appropriate interval].
- Receipt of blood or blood products within the past 6 months or planned use during the study.
- 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-Barré syndrome
- Pregnant woman;
- Breastfeeding woman [if volunteer will receive LAIV4]
- 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.
About this study
Official title: Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers. U19-HIPC Vaccination and Infection: Indicators of Immunological Health and Responsiveness
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.
Read the 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.
- Conditions
- Influenza
- Being tested
- Fluzone®, FluMist®
- Keywords
- Quadrivalent inactivated influenza vaccine, Quadrivalent live, attenuated influenza vaccine, Adults with obstructive sleep apnea
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone®Biological
quadrivalent, inactivated influenza virus vaccine, intramuscular
FluMist®Biological
quadrivalent, live, attenuated influenza vaccine, intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| Pilot phase | Other | Participants will receive the current 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. Receives: Biological: Fluzone® |
| 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.
Number of Participants Who Received Influenza Vaccine
Measured: Day 0
Number of Participants With Related Adverse Events
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 posted18 Jan 2017 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Due to the ACIP guidelines halting the use of LAIV
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelia L. Dekker, Stanford University
- Investigators
- Cornelia Dekker, MD, Principal investigator, Stanford UniversityMark Davis, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023709
- Sponsor's protocol ID
- SU-33722
- Other IDs
- 2U19AI057229-11
- Status last verified
- Mar 2017
- First submitted
- 13 Jan 2017
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers. U19-HIPC Vaccination and Infection: Indicators of Immunological Health and Responsiveness
- ClinicalTrials.gov ID
- NCT03023709
- Acronym / sponsor ID
- SU-33722
- Conditions
- Influenza
- Keywords
- Quadrivalent inactivated influenza vaccine, Quadrivalent live, attenuated influenza vaccine, Adults with obstructive sleep apnea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the ACIP guidelines halting the use of LAIV
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Posted 10 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pilot phase | Other | Biological: Fluzone®Participants will receive the current 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. |
| Study phase | Other | Biological: FluMist®Participants 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
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Generally healthy 18-49 year old male and female patients undergoing tonsillectomy for obstructive sleep apnea.
- Willing 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 (27 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) for study volunteers; not a contraindication for enrolling as a pilot phase volunteer receiving IIV4.
- Allergy to egg or egg products or to vaccine components (including gentamicin, gelatin, arginine or MSG for participants receiving LAIV4).
- 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 |
|---|---|---|
| Fluzone®quadrivalent, inactivated influenza virus vaccine, intramuscular | Biological | Pilot phase |
| FluMist®quadrivalent, live, attenuated influenza vaccine, intranasal spray | Biological | Study phase |
Primary outcome
Number of Participants Who Received Influenza Vaccine
Time frame: Day 0
Number of Participants With Related Adverse Events
Time frame: Day 0 to 14 post-immunization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Cornelia Dekker, MD principal investigator
Stanford University
Mark Davis, PhD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluzone® and FluMist® in people with Influenza, run by Stanford University.
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 27 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: stopped early, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 10 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Received Influenza Vaccine (time frame: Day 0). 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 10 May 2017.