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InfluenzaPhase 1SLVP028NCT03088904

Genetic and Environmental Factors in the Response to Influenza Vaccination

A Phase 1 study testing FluMist® Quadrivalent and Fluzone® Quadrivalent vaccine in people with Influenza and Healthy, run by Stanford University at 1 site in United States.

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

The purpose of the study is to investigate and compare the immune responses to influenza vaccination in monozygotic (identical) and dizygotic (fraternal) twins to determine the roles of genetics and environment in the response to flu vaccination. Read more about this study

Who is it for?
Ages 12 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Healthy
What is being tested?
FluMist® Quadrivalent and Fluzone® Quadrivalent vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
1 siteUnited States
Study dates
3 Oct 2014to 12 Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

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 12 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Otherwise healthy, 12-49 years old, identical (MZ) or fraternal (DZ) twins.
  • Willing to complete the informed consent process (including assent for minors 12-17 years of age, inclusive).
  • Availability for follow-up for the planned duration of the study at least 28 days after immunization.
  • 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 in LAIV)
  • Life-threatening reactions to previous influenza vaccinations.
  • Asthma (If yes, not eligible for Group C).
  • Active systemic or serious concurrent illness, including febrile illness on the day of vaccination.
  • History of immunodeficiency (including HIV infection).
Show all 29Show 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).
  • In close contact with anyone who has a severely weakened immune system and requires a protective environment (If yes, may be ineligible for Group C; exposure to such persons should be avoided for 7 days after receipt of LAIV).
  • 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.
  • For children or adolescents through 17 years of age, receiving aspirin therapy or aspirin-containing products (If yes, not eligible for Group C).
  • 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 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 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.
  • Has taken an influenza antiviral medication within 48 hours prior to study vaccination (If yes, not eligible for Group C).
  • History of Guillain-Barré syndrome
  • Pregnant woman
  • Lactating woman (If yes, not eligible for Group C).
  • 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

    Stanford, California, 94305-5208

Other trials in United States

About this study

The purpose of the study is to investigate and compare the immune responses to influenza vaccination in monozygotic (identical) and dizygotic (fraternal) twins to determine the roles of genetics and environment in the response to flu vaccination.

Read the detailed description

This is a phase 1 study of 120 healthy 12-49 year old adolescents and adult volunteers who are given licensed seasonal influenza vaccine. There are no exclusions for gender, ethnicity or race. The volunteers will be enrolled into one of 3 groups:

Group A: Up to 40 healthy monozygotic (MZ) twin volunteers, 12-49 years old, will be given inactivated influenza vaccine quadrivalent (IIV4). Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 6-8 and Day 28+ 7 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Group B: Up to 40 healthy dizygotic (DZ) twin volunteers, 12-49 years old, will be given inactivated influenza vaccine quadrivalent (IIV4). Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 6-8 and Day 28+7 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).

Group C: Up to 40 healthy monozygotic (MZ) twin volunteers, 12-49 years old, will be randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent (IIV4) or live, attenuated influenza vaccine quadrivalent (LAIV4). Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 6-8 and Day 28+7 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs). This group was terminated in 2016 due to ACIP recommendations against the use of LAIV but was reopened in 2018 with the availability of LAIV4.

Each twin is counted as a single participant. All reporting numbers reflect the number of participants, not the number of twin pairs.

Conditions
Influenza, Healthy
Being tested
FluMist® Quadrivalent, Fluzone® Quadrivalent vaccine
Keywords
Inactivated influenza vaccine quadrivalent, Live, attenuated influenza vaccine quadrivalent, Monozygotic twins, Dizygotic twins, Adults, Adolescents
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluMist® QuadrivalentBiological

    LAIV4 vaccine dosage is 0.2 mL. Vaccine will be administered as an intranasal spray. Each sprayer contains a single dose of FluMist® Quadrivalent; approximately one-half of the contents should be administered into each nostril. 0.1 mL (i.e., half of the dose from a single FluMist sprayer) is administered into each nostril while the recipient is in an upright position. Insert the tip of the sprayer just inside the nose and rapidly depress the plunger until the dose-divider clip stops the plunger. The dose divider clip is removed from the sprayer to administer the second half of the dose (0.1 mL) into the other nostril.

  • Fluzone® Quadrivalent vaccineBiological

    IIV4 vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection into the deltoid muscle.

Study groups in NCT03088904
Study groupRoleWhat they receive
Group A: MZ twins (IIV4)ExperimentalGroup A: Up to 40 healthy monozygotic (MZ) individual twin volunteers, 12-49 years old, will be given inactivated influenza vaccine quadrivalent (IIV4) Fluzone® Quadrivalent vaccine. Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 6-8 and Day 28+7 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).
Receives: Biological: Fluzone® Quadrivalent vaccine
Group B: DZ twins (IIV4)ExperimentalGroup B: Up to 40 healthy dizygotic (DZ) individual twin volunteers, 12-49 years old, will be given inactivated influenza vaccine quadrivalent (IIV4) Fluzone® Quadrivalent vaccine. Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), and Day 6-8 and Day 28+ 7 (post-immunization). All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs).
Receives: Biological: Fluzone® Quadrivalent vaccine
Group C: MZ twins (IIV4 or LAIV4)ExperimentalGroup C: Up to 40 healthy monozygotic (MZ) individual twin volunteers, 12-49 years old, will be randomized within the twin pair to receive either inactivated influenza vaccine quadrivalent (IIV4) Fluzone® Quadrivalent vaccine or live, attenuated influenza vaccine quadrivalent (LAIV4) FluMist® Quadrivalent. Each volunteer will complete a total of 3 visits: Day 0 (pre-immunization), Day 6-8 and Day 28+7 post-immunization. All visits will consist of drawing blood for study assays and monitoring for serious adverse events (SAEs). This group was terminated in 2016 due to ACIP recommendations against the use of LAIV but may be reopened in 2018 pending LAIV4 availability.
Receives: Biological: FluMist® Quadrivalent; Biological: Fluzone® Quadrivalent vaccine

What is being measured

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

  1. Hemagglutination inhibition (HAI) titers in response to influenza vaccination.

    Measured: Day 0 to Day 28

  2. Interferon-gamma (IFN-γ) production by T cells

    Measured: Day 0 to Day 28

  3. IFN-γ production by Natural Killer (NK) cells.

    Measured: Day 0 to Day 28

Secondary outcomes (2)

  1. Sequencing of T-cell receptor (TCR)ab and Immunoglobulin Genes

    B and T cells will be sequenced for their antibody repertoires.

    Measured: Day 0 to Day 28

  2. Natural Killer (NK) repertoire.

    Mass cytometry will be used to assess the NK cell repertoire.

    Measured: Day 0 to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2017
  2. Study start3 Oct 2014
  3. Primary completion12 Dec 2018
  4. Study completion12 Dec 2018

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 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03088904
Sponsor's protocol ID
31050
Other IDs
2U19AI057229-11
Acronym
SLVP028
Status last verified
Feb 2020
First submitted
17 Mar 2017
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FluMist® Quadrivalent and Fluzone® Quadrivalent vaccine in people with Influenza and Healthy, 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 29 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 13 Feb 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Hemagglutination inhibition (HAI) titers in response to influenza vaccination. (time frame: Day 0 to Day 28). The study lists 3 primary outcomes in all. 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 NCT03088904.

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 13 Feb 2020.

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