InfluenzaPhase 4NCT03028987
Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection (SLVP031)
A Phase 4 study testing Fluzone® and FluMist® in people with Influenza, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is provide a better understanding of the adaptive immune response to the licensed flu vaccines. The investigators hope the information learned from this study will help identify and describe important factors of influenza immunity especially of or specific proteins associated with the T-cell… 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2014to 18 Nov 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
- Otherwise healthy 18-49 years old identical (MZ) twins identified as DR1501+ or DR0701+ by lab assay results. Both twins in the pair must be willing to participate in the study.
- 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 and vital signs.
Who cannot join
- Prior off-study vaccination with the current year's seasonal influenza vaccine.
- Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, arginine or MSG
- Life-threatening reactions to previous influenza vaccinations
- Asthma (a contraindication for receipt of LAIV4)
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
Show all 27Show fewer
- Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- Blood pressure >150 systolic or >95 diastolic at first study visit and the day of vaccination.
- 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 in all groups; inhaled steroid use is not permissible)
- 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 must be reviewed by investigator to determine if this would affect the volunteer's safety.
- Has taken an influenza antiviral medication within 48 hours prior to study vaccination [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 used 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 ( ~ 28 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 (~ 28 days after study vaccination)
- Need for allergy immunization (that cannot be postponed) during the study period.
- History of Guillain-Barré syndrome
- Pregnant or lactating 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 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 School of Medicine
Stanford, California, 94305
About this study
Official title: Project 1. The Role of CD4+ Memory Phenotype, Memory, and Effector T-Cells in Vaccination and Infection - Influenza-specific DR1501+ and DR0701+ T-cells
The purpose of this study is provide a better understanding of the adaptive immune response to the licensed flu vaccines. The investigators hope the information learned from this study will help identify and describe important factors of influenza immunity especially of or specific proteins associated with the T-cell immune response.
Read the detailed description
This is a study of up to 20 healthy monozygotic (MZ) twins, 18-49 years old, that are participants from past Stanford-LPCH Vaccine Program trials and who have been identified as human leukocyte antigen (HLA) DR1501+ or DR0701+ by lab assay results. Volunteers will be contacted to assess interest in participating in this study. Both twins in the pair must be willing to participate in the study. All participants will be randomized within the twin pair to receive either the seasonal live, attenuated influenza vaccine (LAIV) or the seasonal quadrivalent inactivated influenza vaccine (IIV4). Immunization will be at Day 0, blood samples for immunogenicity assays will be collected prior to immunization and at Days 7 (6-8) and 28 (24-32).
This study was halted due to the Advisory Committee on Immunization Practices decision not to recommend use of LAIV.
- Conditions
- Influenza
- Being tested
- Fluzone®, FluMist®
- Keywords
- Quadrivalent, inactivated influenza vaccine, Quadrivalent, live, attenuated influenza vaccine, Identical twin adults
- 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
Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine)
FluMist®Biological
FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine)
| Study group | Role | What they receive |
|---|---|---|
| LAIV randomized | Other | Volunteers are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . Receives: Biological: FluMist® |
| IIV4 randomized | Other | Volunteers are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® Receives: Biological: Fluzone® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received Influenza Vaccine
Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment
Measured: Day 0
Secondary outcomes (1)
Number of Participants With Related Adverse Events
Number of individual twins who experienced related adverse events through the course of the study.
Measured: Day 0 to 28 post-immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start19 Nov 2014
- Primary completion18 Nov 2015
- Study completion18 Nov 2015
Why it stopped: LAIV was no longer recommended by ACIP
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 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 UniversityK. Christopher Garcia, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028987
- Sponsor's protocol ID
- SU-31434-2014-2019
- Other IDs
- 2U19AI057229-11
- Status last verified
- Jul 2017
- First submitted
- 19 Jan 2017
- Last updated
- 12 Sep 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 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 1. The Role of CD4+ Memory Phenotype, Memory, and Effector T-Cells in Vaccination and Infection - Influenza-specific DR1501+ and DR0701+ T-cells
- ClinicalTrials.gov ID
- NCT03028987
- Acronym / sponsor ID
- SU-31434-2014-2019
- Conditions
- Influenza
- Keywords
- Quadrivalent, inactivated influenza vaccine, Quadrivalent, live, attenuated influenza vaccine, Identical twin adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: LAIV was no longer recommended by ACIP
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 19 Nov 2014 (actual)
- Primary completion
- 18 Nov 2015 (actual)
- Study completion
- 18 Nov 2015 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 12 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is provide a better understanding of the adaptive immune response to the licensed flu vaccines. The investigators hope the information learned from this study will help identify and describe important factors of influenza immunity especially of or specific proteins associated with the T-cell immune response.
Detailed description
This is a study of up to 20 healthy monozygotic (MZ) twins, 18-49 years old, that are participants from past Stanford-LPCH Vaccine Program trials and who have been identified as human leukocyte antigen (HLA) DR1501+ or DR0701+ by lab assay results. Volunteers will be contacted to assess interest in participating in this study. Both twins in the pair must be willing to participate in the study. All participants will be randomized within the twin pair to receive either the seasonal live, attenuated influenza vaccine (LAIV) or the seasonal quadrivalent inactivated influenza vaccine (IIV4). Immunization will be at Day 0, blood samples for immunogenicity assays will be collected prior to immunization and at Days 7 (6-8) and 28 (24-32).
This study was halted due to the Advisory Committee on Immunization Practices decision not to recommend use of LAIV.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAIV randomized | Other | Biological: FluMist®Volunteers are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . |
| IIV4 randomized | Other | Biological: Fluzone®Volunteers are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Otherwise healthy 18-49 years old identical (MZ) twins identified as DR1501+ or DR0701+ by lab assay results. Both twins in the pair must be willing to participate in the study.
- 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 and vital signs.
Key exclusion criteria (27 listed)
- Prior off-study vaccination with the current year's seasonal influenza vaccine.
- Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, arginine or MSG
- Life-threatening reactions to previous influenza vaccinations
- Asthma (a contraindication for receipt of 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®Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine) | Biological | IIV4 randomized |
| FluMist®FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine) | Biological | LAIV randomized |
Primary outcome
Number of Participants Who Received Influenza Vaccine
Time frame: Day 0
Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment
1 secondary outcome
Number of Participants With Related Adverse Events
Time frame: Day 0 to 28 post-immunization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 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
K. Christopher Garcia, PhD principal investigator
Stanford University
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 Fluzone® and 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 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 12 Sep 2017. 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?
Yes. Results are posted in the registry (first posted 12 Sep 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). 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 12 Sep 2017.