InfluenzaPhase 4NCT03022422
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 3, 2011
A Phase 4 study testing TIV and High-Dose TIV in people with Influenza, run by Stanford University.
Trial summary
This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- TIV and High-Dose TIV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Dec 2011
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Otherwise healthy, ambulatory adults, ages 18-30 years (identical or fraternal twin pairs), 40-64 years (identical or fraternal twin pairs) or 65-100 years (identical twin pairs).
- Willing to complete the informed consent process.
- Availability for follow-up for the planned duration of the study at least 28 days after immunization.
- Acceptable medical history and vital signs.
Who cannot join
- Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) in Fall 2011
- Allergy to egg or egg products, or to vaccine components, including thimerosal (if TIV multidose vials used)
- Allergy to latex (for Group F only - may be assigned to Fluzone High-Dose). Review with investigator.
- Life-threatening reactions to previous influenza vaccinations
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
Show all 24Show 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 Visit 1
- Hospitalization in the past year for congestive heart failure or emphysema.
- Chronic Hepatitis B or C
- Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays, topical steroids and inhaled steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
- 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 aspirin up to 325 mg.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
- Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Inactivated vaccine 14 days prior to vaccination
- Live, attenuated vaccine within 60 days of vaccination
- History of Guillain-Barre Syndrome
- Pregnant or lactating woman
- Use of investigational agents within 30 days prior to enrollment
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
- 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: Protective Mechanisms Against a Pandemic Respiratory Virus: B-Cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 3, 2011
This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.
Read the detailed description
The investigators plan to study the response to influenza vaccines much more broadly and deeply across different age groups and with different vaccine formulations and to probe the influence of genetics on these responses using monozygotic and dizygotic twins. On an investigational basis, investigators plan to compare various immunological responses, identify age-specific biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of T-cell repertoire to an influenza vaccine within an individual as a function of age and to what degree this is genetically determined.
Twin Groups B-E will receive a single administration of the 2011-2012 formulation of seasonal trivalent inactivated influenza vaccine (TIV). Group F, elderly monozygotic twin participants, will be randomly assigned to receive a single dose of inactivated vaccine, either the usual dose or the High-Dose TIV. Blood samples to conduct the assays described will be taken at pre-immunization, Days 7-10 and 28 post-immunization. The number of individual participants, not the number of twin pairs is being reported in all the modules.
- Conditions
- Influenza
- Being tested
- TIV, High-Dose TIV
- Keywords
- Trivalent, inactivated influenza vaccine, High-Dose trivalent, inactivated influenza vaccine, Adult and elderly identical twins, Adult fraternal twins
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVBiological
Also called Fluzone® TIV
Influenza Virus Vaccine Suspension for Intramuscular Injection
High-Dose TIVBiological
Also called High-Dose Fluzone® TIV
High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group B: 18-30 yo identical twins (TIV) | Other | Individual twins to receive Fluzone® standard TIV Receives: Biological: TIV |
| Group C: 18-30 yo fraternal twins (TIV) | Other | Individual twins to receive Fluzone® standard TIV Receives: Biological: TIV |
| Group D: 40-64 yo identical twins (TIV) | Other | Individual twins to receive Fluzone® standard TIV Receives: Biological: TIV |
| Group E: 40-64 yo fraternal twins (TIV) | Other | Individual twins to receive Fluzone® standard TIV Receives: Biological: TIV |
| Group F: 65-100 yo identical twins (TIV) | Other | Individual twins to receive Fluzone® standard TIV Receives: Biological: TIV |
| Group F: 65-100 yo identical twins (High-Dose TIV) | Other | Individual twins to receive High-Dose Fluzone® TIV Receives: Biological: High-Dose TIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Individual Twins Who Received Influenza Vaccine
Measured: Day 0
Secondary outcomes (1)
Number of Individual Twins 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 posted16 Jan 2017 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
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.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 63 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 UniversityGarry Nolan, PhD, Principal investigator, Stanford UniversityAnn Arvin, MD, Principal investigator, Stanford UniversityStephen Quake, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022422
- Sponsor's protocol ID
- SU-17219-2011
- Other IDs
- 2U19AI057229-06
- Status last verified
- Aug 2017
- First submitted
- 12 Jan 2017
- Last updated
- 21 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kay AW, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Holmes S, Blish CA. Enhanced natural killer-cell and T-cell responses to influenza A virus during pregnancy. Proc Natl Acad Sci U S A. 2014 Oct 7;111(40):14506-11. doi: 10.1073/pnas.1416569111. Epub 2014 Sep 22.
PubMed 25246558O'Gorman WE, Huang H, Wei YL, Davis KL, Leipold MD, Bendall SC, Kidd BA, Dekker CL, Maecker HT, Chien YH, Davis MM. The Split Virus Influenza Vaccine rapidly activates immune cells through Fcgamma receptors. Vaccine. 2014 Oct 14;32(45):5989-97. doi: 10.1016/j.vaccine.2014.07.115. Epub 2014 Sep 6.
PubMed 25203448Brodin P, Jojic V, Gao T, Bhattacharya S, Angel CJ, Furman D, Shen-Orr S, Dekker CL, Swan GE, Butte AJ, Maecker HT, Davis MM. Variation in the human immune system is largely driven by non-heritable influences. Cell. 2015 Jan 15;160(1-2):37-47. doi: 10.1016/j.cell.2014.12.020.
PubMed 25594173Cheung P, Vallania F, Warsinske HC, Donato M, Schaffert S, Chang SE, Dvorak M, Dekker CL, Davis MM, Utz PJ, Khatri P, Kuo AJ. Single-Cell Chromatin Modification Profiling Reveals Increased Epigenetic Variations with Aging. Cell. 2018 May 31;173(6):1385-1397.e14. doi: 10.1016/j.cell.2018.03.079. Epub 2018 Apr 26.
PubMed 29706550de Bourcy CFA, Dekker CL, Davis MM, Nicolls MR, Quake SR. Dynamics of the human antibody repertoire after B cell depletion in systemic sclerosis. Sci Immunol. 2017 Sep 29;2(15):eaan8289. doi: 10.1126/sciimmunol.aan8289.
PubMed 28963118
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Mechanisms Against a Pandemic Respiratory Virus: B-Cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 3, 2011
- ClinicalTrials.gov ID
- NCT03022422
- Acronym / sponsor ID
- SU-17219-2011
- Conditions
- Influenza
- Keywords
- Trivalent, inactivated influenza vaccine, High-Dose trivalent, inactivated influenza vaccine, Adult and elderly identical twins, Adult fraternal twins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Posted 11 May 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 investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.
Detailed description
The investigators plan to study the response to influenza vaccines much more broadly and deeply across different age groups and with different vaccine formulations and to probe the influence of genetics on these responses using monozygotic and dizygotic twins. On an investigational basis, investigators plan to compare various immunological responses, identify age-specific biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of T-cell repertoire to an influenza vaccine within an individual as a function of age and to what degree this is genetically determined.
Twin Groups B-E will receive a single administration of the 2011-2012 formulation of seasonal trivalent inactivated influenza vaccine (TIV). Group F, elderly monozygotic twin participants, will be randomly assigned to receive a single dose of inactivated vaccine, either the usual dose or the High-Dose TIV. Blood samples to conduct the assays described will be taken at pre-immunization, Days 7-10 and 28 post-immunization. The number of individual participants, not the number of twin pairs is being reported in all the modules.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group B: 18-30 yo identical twins (TIV) | Other | Biological: TIVIndividual twins to receive Fluzone® standard TIV |
| Group C: 18-30 yo fraternal twins (TIV) | Other | Biological: TIVIndividual twins to receive Fluzone® standard TIV |
| Group D: 40-64 yo identical twins (TIV) | Other | Biological: TIVIndividual twins to receive Fluzone® standard TIV |
| Group E: 40-64 yo fraternal twins (TIV) | Other | Biological: TIVIndividual twins to receive Fluzone® standard TIV |
| Group F: 65-100 yo identical twins (TIV) | Other | Biological: TIVIndividual twins to receive Fluzone® standard TIV |
| Group F: 65-100 yo identical twins (High-Dose TIV) | Other | Biological: High-Dose TIVIndividual twins to receive High-Dose Fluzone® TIV |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Otherwise healthy, ambulatory adults, ages 18-30 years (identical or fraternal twin pairs), 40-64 years (identical or fraternal twin pairs) or 65-100 years (identical twin pairs).
- Willing to complete the informed consent process.
- Availability for follow-up for the planned duration of the study at least 28 days after immunization.
- Acceptable medical history and vital signs.
Key exclusion criteria (24 listed)
- Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) in Fall 2011
- Allergy to egg or egg products, or to vaccine components, including thimerosal (if TIV multidose vials used)
- Allergy to latex (for Group F only - may be assigned to Fluzone High-Dose). Review with investigator.
- Life-threatening reactions to previous influenza vaccinations
- 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 |
|---|---|---|
| TIVAlso: Fluzone® TIVInfluenza Virus Vaccine Suspension for Intramuscular Injection | Biological | Group B: 18-30 yo identical twins (TIV), Group C: 18-30 yo fraternal twins (TIV), Group D: 40-64 yo identical twins (TIV), Group E: 40-64 yo fraternal twins (TIV), Group F: 65-100 yo identical twins (TIV) |
| High-Dose TIVAlso: High-Dose Fluzone® TIVHigh-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for intramuscular injection | Biological | Group F: 65-100 yo identical twins (High-Dose TIV) |
Primary outcome
Number of Individual Twins Who Received Influenza Vaccine
Time frame: Day 0
1 secondary outcome
Number of Individual Twins 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 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25246558Kay AW, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Holmes S, Blish CA. Enhanced natural killer-cell and T-cell responses to influenza A virus during pregnancy. Proc Natl Acad Sci U S A. 2014 Oct 7;111(40):14506-11. doi: 10.1073/pnas.1416569111. Epub 2014 Sep 22.
- Background: PubMed 25203448O'Gorman WE, Huang H, Wei YL, Davis KL, Leipold MD, Bendall SC, Kidd BA, Dekker CL, Maecker HT, Chien YH, Davis MM. The Split Virus Influenza Vaccine rapidly activates immune cells through Fcgamma receptors. Vaccine. 2014 Oct 14;32(45):5989-97. doi: 10.1016/j.vaccine.2014.07.115. Epub 2014 Sep 6.
- Background: PubMed 25594173Brodin P, Jojic V, Gao T, Bhattacharya S, Angel CJ, Furman D, Shen-Orr S, Dekker CL, Swan GE, Butte AJ, Maecker HT, Davis MM. Variation in the human immune system is largely driven by non-heritable influences. Cell. 2015 Jan 15;160(1-2):37-47. doi: 10.1016/j.cell.2014.12.020.
- Derived from this study: PubMed 29706550Cheung P, Vallania F, Warsinske HC, Donato M, Schaffert S, Chang SE, Dvorak M, Dekker CL, Davis MM, Utz PJ, Khatri P, Kuo AJ. Single-Cell Chromatin Modification Profiling Reveals Increased Epigenetic Variations with Aging. Cell. 2018 May 31;173(6):1385-1397.e14. doi: 10.1016/j.cell.2018.03.079. Epub 2018 Apr 26.
- Derived from this study: PubMed 28963118de Bourcy CFA, Dekker CL, Davis MM, Nicolls MR, Quake SR. Dynamics of the human antibody repertoire after B cell depletion in systemic sclerosis. Sci Immunol. 2017 Sep 29;2(15):eaan8289. doi: 10.1126/sciimmunol.aan8289.
- 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
Garry Nolan, PhD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TIV and High-Dose TIV 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 24 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 Aug 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 11 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 Individual Twins 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?
On the ClinicalTrials.gov record for NCT03022422, which also lists 5 linked publications.
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 Aug 2017.