InfluenzaPhase 4NCT03023553
The Human Mucosal Immune Responses to Influenza Virus (SLVP026)
A Phase 4 study testing Fluzone® and FluMist® in people with Influenza, run by Stanford University.
Trial summary
This study will examine the immune responses to the seasonal influenza vaccine in single cells of the nasal passages when compared with cells in circulating blood. Read more about this study
- Who is it for?
- Ages 18 to 30 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
- 13 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Feb 2013
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Otherwise healthy, ambulatory adult between the ages of 18-30 years
- Willing to complete the informed consent process.
- Availability for follow-up at Day 2 (LAIV Group only)
- Acceptable medical history by review of inclusion/exclusion criteria and vital signs.
Who cannot join
- Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV
- Allergy to egg or egg products, or to vaccine components, including thimerosal (TIV multidose vials only), or gentamicin, gelatin, arginine or MSG (for LAIV only).
- Life-threatening reactions to previous influenza vaccinations
- Asthma or history of wheezing (except for controls in the study who will be assigned to receive TIV).
- 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, 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
- 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 for allergies and topical steroids are permissible. Inhaled steroids for conditions such as asthma are not permissible for volunteers in the LAIV group.
- Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (LAIV Group only).
- 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. aspirin per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety..
- Receipt of blood or blood products within the past 6 months of planned used during the study.
- Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination prior to completion of the last study visit.
- Live, attenuated vaccine within 60 days of vaccination or planned non-study vaccination prior to completion of the last study visit.
- History of Guillain-Barré Syndrome
- Pregnant or lactating woman
- Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits.
- 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.
About this study
Official title: The Human Mucosal Immune Responses to Influenza Virus: A Systems Biology Approach. Innate Immune Responses to Influenza Virus in Single Human Nasal Epithelial Cells
This study will examine the immune responses to the seasonal influenza vaccine in single cells of the nasal passages when compared with cells in circulating blood.
Read the detailed description
Using state-of-the-art technology, the investigators hope the information learned from this study will help identify and describe important factors in the early-stage development of influenza immunity and possibly lead to the development of more effective vaccines. This study will be conducted in healthy male and female volunteers 18-30 years of age who received one of two seasonal influenza vaccine types, intramuscular standard trivalent inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV) given by intranasal spray.
Participants are divided into two groups. The control group will receive the 2012-2013 formulation of the standard intramuscular trivalent inactivated influenza vaccine (TIV). A blood sample and nasopharyngeal swab samples (one from each nostril) will be collected at a single visit, Day 0. For those in the live, attenuated influenza vaccine (LAIV) group, at the first visit, they will receive a single administration of the 2012-2013 formulation of LAIV. At the second study visit two days later, they will provide a blood sample and two nasopharyngeal swab samples (one from each nostril).
- Conditions
- Influenza
- Being tested
- Fluzone®, FluMist®
- Keywords
- Trivalent, inactivated influenza vaccine, Live, attenuated influenza vaccine, Nasopharyngeal swabs, Young 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
Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist®Biological
Influenza Virus Vaccine Live, Intranasal Spray
| Study group | Role | What they receive |
|---|---|---|
| TIV Group | Other | Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®. Receives: Biological: Fluzone® |
| LAIV Group | Other | Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®. Receives: Biological: FluMist® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants From Each Arm Who Received Influenza Vaccine
Measured: Day 0 to 28
Secondary outcomes (1)
Number of Participants With Related Adverse Events
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 posted18 Jan 2017 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 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 UniversityHarry Greenberg, MD, Principal investigator, Stanford UniversityXiaosong He, PhD, Principal investigator, Stanford Universityh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023553
- Sponsor's protocol ID
- SU-25537
- Other IDs
- U19AI090019
- Status last verified
- Mar 2017
- First submitted
- 13 Jan 2017
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique identification code and the volunteer identity (except for age) will not be disclosed.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Human Mucosal Immune Responses to Influenza Virus: A Systems Biology Approach. Innate Immune Responses to Influenza Virus in Single Human Nasal Epithelial Cells
- ClinicalTrials.gov ID
- NCT03023553
- Acronym / sponsor ID
- SU-25537
- Conditions
- Influenza
- Keywords
- Trivalent, inactivated influenza vaccine, Live, attenuated influenza vaccine, Nasopharyngeal swabs, Young adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Posted 9 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the immune responses to the seasonal influenza vaccine in single cells of the nasal passages when compared with cells in circulating blood.
Detailed description
Using state-of-the-art technology, the investigators hope the information learned from this study will help identify and describe important factors in the early-stage development of influenza immunity and possibly lead to the development of more effective vaccines. This study will be conducted in healthy male and female volunteers 18-30 years of age who received one of two seasonal influenza vaccine types, intramuscular standard trivalent inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV) given by intranasal spray.
Participants are divided into two groups. The control group will receive the 2012-2013 formulation of the standard intramuscular trivalent inactivated influenza vaccine (TIV). A blood sample and nasopharyngeal swab samples (one from each nostril) will be collected at a single visit, Day 0. For those in the live, attenuated influenza vaccine (LAIV) group, at the first visit, they will receive a single administration of the 2012-2013 formulation of LAIV. At the second study visit two days later, they will provide a blood sample and two nasopharyngeal swab samples (one from each nostril).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIV Group | Other | Biological: Fluzone®Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®. |
| LAIV Group | Other | Biological: FluMist®Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Otherwise healthy, ambulatory adult between the ages of 18-30 years
- Willing to complete the informed consent process.
- Availability for follow-up at Day 2 (LAIV Group only)
- Acceptable medical history by review of inclusion/exclusion criteria and vital signs.
Key exclusion criteria (25 listed)
- Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV
- Allergy to egg or egg products, or to vaccine components, including thimerosal (TIV multidose vials only), or gentamicin, gelatin, arginine or MSG (for LAIV only).
- Life-threatening reactions to previous influenza vaccinations
- Asthma or history of wheezing (except for controls in the study who will be assigned to receive TIV).
- 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®Influenza Virus Vaccine Suspension for Intramuscular Injection | Biological | TIV Group |
| FluMist®Influenza Virus Vaccine Live, Intranasal Spray | Biological | LAIV Group |
Primary outcome
Number of Participants From Each Arm Who Received Influenza Vaccine
Time frame: Day 0 to 28
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 21 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique identification code and the volunteer identity (except for age) will not be disclosed.
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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
Harry Greenberg, MD principal investigator
Stanford University
Xiaosong He, PhD principal investigator
Stanford Universityh
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 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: finished, as of the sponsor's last update on 21 Apr 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 9 Mar 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 From Each Arm Who Received Influenza Vaccine (time frame: Day 0 to 28). 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 Apr 2017.