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InfluenzaPhase 4SLVP023NCT02987374

Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization

A Phase 4 study testing 2011-2012 Fluzone IIV3 (IM) 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

The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in healthy young adults by vaccinating participants and obtaining blood samples at designated time points before and after vaccination. 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?
2011-2012 Fluzone IIV3 (IM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
May 2012to Dec 2012
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, 18-30 year old young adult.
  • Availability for follow-up for the planned duration of the study at least 180 days after immunization.
  • Acceptable medical history by medical history and vital signs.

Who cannot join

  • Prior vaccination with 2010-2011 seasonal TIV or LAIV.
  • Prior off-study vaccination with the current 2011-2012 seasonal TIV or LAIV
  • Weight less than 110 pounds.
  • Allergy to egg or egg products, or to vaccine components, including gelatin or thimerosal (thimerosal in TIV multidose vials only).
  • Life-threatening reactions to previous influenza vaccinations
  • Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
Show all 26Show fewer
  • 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.
  • 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 and topical steroids are permissible.
  • 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.
  • 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
  • Receipt of inactivated vaccine 14 days prior to study enrollment, planned vaccinations prior to completion of Visit 09 (Day 28 after study vaccination), or planned vaccination 14 days prior to Visit 10 (6 months after study vaccination).
  • Receipt of live, attenuated vaccine 60 days prior to study enrollment, planned vaccination prior to completion of Visit 09 (Day 28 after study vaccination), or planned vaccination 14 days prior to Visit 10 (6 months after study vaccination).
  • History of Guillain-Barré Syndrome
  • Pregnant or lactating woman
  • Use of investigational agents within 30 days prior to study enrollment or planned use during the study period.
  • Donation of the equivalent of a unit of blood within 6 weeks prior to study enrollment, or during the first 5 weeks of study participation.
  • A member of the study team or their family member, to include investigators, research laboratory staff, clinical research staff.
  • 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

The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in healthy young adults by vaccinating participants and obtaining blood samples at designated time points before and after vaccination.

Read the detailed description

This is an exploratory study using a strategy that has not been previously employed to investigate B-cell responses. Investigators will collect blood samples from the volunteers at a higher frequency than in the two previous flu seasons to better define the dynamic response to vaccination. The objective is to compare the Ig gene repertoire before and after vaccination by deep sequencing PBMC and proteomic analysis of antibody CDR3 regions at 10 different time points before and after immunization.

This is a Phase IV study of healthy adults who are given standard TIV off-season. There are no exclusions for gender, ethnicity or race. Following confirmation of written informed consent, baseline blood samples will be drawn from all study participants at Day -5, Day -3 and Day 0 prior to immunization, and at Days 1, 4, 7, 9, 11, 28 and 180 post-immunization. Volunteers will be vaccine-naïve for the 2010-2011 and 2011-2012 seasonal influenza vaccines. All participants will receive a single dose of the current seasonal influenza vaccine by intramuscular (IM) injection at Day 0.

Conditions
Influenza
Being tested
2011-2012 Fluzone IIV3 (IM)
Keywords
Influenza Vaccine
Medical subject headings
Influenza, Human

What participants receive

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

  • 2011-2012 Fluzone IIV3 (IM)Biological

    2011-2012 Fluzone IIV3 vaccine delivered intramuscularly (IM)

Study groups in NCT02987374
Study groupRoleWhat they receive
2011-2012 Fluzone IIV3 (IM)OtherSeasonal trivalent flu vaccine: NDC No 49281-011-50
Receives: Biological: 2011-2012 Fluzone IIV3 (IM)

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 to 180 post-immunization

Secondary outcomes (1)

  1. Number of Participants With Related Adverse Events

    Measured: Day 0 to 180 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 posted8 Dec 2016 (estimated)
  2. Study startMay 2012
  3. Primary completionDec 2012
  4. Study completionDec 2012

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02987374
Sponsor's protocol ID
SU-24167
Other IDs
U19AI057229-06
Acronym
SLVP023
Status last verified
Apr 2017
First submitted
6 Dec 2016
Last updated
21 Apr 2017
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 ID code and the volunteer identity (except for age) will not be disclosed.

Publications

  • Lee J, Boutz DR, Chromikova V, Joyce MG, Vollmers C, Leung K, Horton AP, DeKosky BJ, Lee CH, Lavinder JJ, Murrin EM, Chrysostomou C, Hoi KH, Tsybovsky Y, Thomas PV, Druz A, Zhang B, Zhang Y, Wang L, Kong WP, Park D, Popova LI, Dekker CL, Davis MM, Carter CE, Ross TM, Ellington AD, Wilson PC, Marcotte EM, Mascola JR, Ippolito GC, Krammer F, Quake SR, Kwong PD, Georgiou G. Molecular-level analysis of the serum antibody repertoire in young adults before and after seasonal influenza vaccination. Nat Med. 2016 Dec;22(12):1456-1464. doi: 10.1038/nm.4224. Epub 2016 Nov 7.

    PubMed 27820605

  • Horns F, Vollmers C, Dekker CL, Quake SR. Signatures of selection in the human antibody repertoire: Selective sweeps, competing subclones, and neutral drift. Proc Natl Acad Sci U S A. 2019 Jan 22;116(4):1261-1266. doi: 10.1073/pnas.1814213116. Epub 2019 Jan 8.

    PubMed 30622180

  • de Bourcy CF, Angel CJ, Vollmers C, Dekker CL, Davis MM, Quake SR. Phylogenetic analysis of the human antibody repertoire reveals quantitative signatures of immune senescence and aging. Proc Natl Acad Sci U S A. 2017 Jan 31;114(5):1105-1110. doi: 10.1073/pnas.1617959114. Epub 2017 Jan 17.

    PubMed 28096374

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 2011-2012 Fluzone IIV3 (IM) 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 3 inclusion and 26 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 26 Dec 2016). 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 to 180 post-immunization). 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 NCT02987374, 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 21 Apr 2017.

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