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InfluenzaPhase 4NCT03022435

T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012

A Phase 4 study testing TIV, High-Dose TIV and LAIV in people with Influenza, run by Stanford University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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, High-Dose TIV and LAIV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
No sites listed yet
Study dates
Oct 2012to Jan 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 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 2012
  • Allergy to egg or egg products, or to vaccine components (including gentamicin, gelatin, arginine or MSG (LAIV for Group B only), and thimerosal (if TIV multidose vials used)
  • Life-threatening reactions to previous influenza vaccinations
  • Active systemic or serious concurrent illness, including febrile illness the day of vaccination
  • History of immunodeficiency (including HIV infection)
  • 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.
Show all 27Show fewer
  • 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 or planned receipt of blood products prior to completion of study visits.
  • Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
  • Receipt of inactivated vaccine 14 days prior to study vaccination, or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)
  • Receipt of live, attenuated vaccine within 60 days of vaccination, or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)
  • Need for allergy immunization (that cannot be postponed) during the study period V01 to V03 (~Day 28)
  • History of Guillain-Barre 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 blood donation prior to completion of Visit 03 ( ~28 Day after study vaccination)
  • A current member of the clinical study team.
  • 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.
  • Asthma or history of wheezing (for Group B volunteers only)
  • Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (for Group B volunteers only)

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 4, 2012

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 different influenza vaccines much more broadly and deeply across different age groups and with different vaccine modalities and to probe the influence of genetics on these responses using monozygotic and dizygotic twins. On an investigational basis, the 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 group B will will be randomly assigned to receive a single dose of inactivated vaccine, either the trivalent inactivated influenza vaccine (TIV) or intranasal live, attenuated influenza vaccine (LAIV). Twin Groups C-E will receive a single administration of TIV. Group F, elderly participants, will be randomly assigned to receive a single dose of inactivated vaccine, either the standard 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.

Groups A, C and E were not enrolled for this year of the five year annual study.

Conditions
Influenza
Being tested
TIV, High-Dose TIV, LAIV
Keywords
Inactivated influenza vaccine, Live, attenuated 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® standard 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

  • LAIVBiological

    Also called FluMist®

    Live, attenuated influenza vaccine for Intranasal Spray

Study groups in NCT03022435
Study groupRoleWhat they receive
Group B: 18-30 yo identical twins (LAIV)OtherParticipants to receive FluMist® LAIV by nasal spray.
Receives: Biological: LAIV
Group B: 18-30 yo identical twins (TIV)OtherParticipants to receive Fluzone® standard TIV
Receives: Biological: TIV
Group D: 40-64 yo identical twins (TIV)OtherParticipants to receive Fluzone® standard TIV
Receives: Biological: TIV
Group F: 65-100 yo identical twins (TIV)OtherParticipants to receive Fluzone® standard TIV
Receives: Biological: TIV
Group F: 65-100 yo identical twins (High-Dose TIV)OtherParticipants to receive High-Dose Fluzone® standard TIV
Receives: Biological: High-Dose TIV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Received Influenza Vaccine

    Measured: Day 0

Secondary outcomes (1)

  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.

  1. First posted16 Jan 2017 (estimated)
  2. Study startOct 2012
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03022435
Sponsor's protocol ID
SU-17219-2012
Other IDs
2U19AI057229-06
Status last verified
May 2017
First submitted
12 Jan 2017
Last updated
22 May 2017
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 25246558

  • O'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 25203448

  • Kay AW, Bayless NL, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Blish CA. Pregnancy Does Not Attenuate the Antibody or Plasmablast Response to Inactivated Influenza Vaccine. J Infect Dis. 2015 Sep 15;212(6):861-70. doi: 10.1093/infdis/jiv138. Epub 2015 Mar 4.

    PubMed 25740957

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TIV, High-Dose TIV and LAIV 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: finished, as of the sponsor's last update on 22 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 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 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 NCT03022435, which also lists 3 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 22 May 2017.

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