CClinicalTrials.gg
CompletedNCT03020498Updated Jun 6, 2018Results posted

B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)

A Phase 4 interventional study of Fluzone and FluMist in Influenza, sponsored by Stanford University. Completed. Open to participants aged 8 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-06.

Sponsored by Stanford University · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
8 Years to 100 Years
Sex
All
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Study summary

In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different influenza vaccines given to identical twins, vaccine-naive young adults and elderly participants.

Read the detailed description

This is an exploratory study of healthy children and adults who are given either standard trivalent, inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV). 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 prior to immunization. The volunteers enrolled in any the three groups (A,B,C) cannot have been immunized with previous year's seasonal influenza vaccine. The identical twins in Groups A will be randomized to each receive a different vaccine (TIV or LAIV) than their twin. The non-twin children in Group B will also be randomly assigned to receive either TIV or LAIV. Non-twin elderly adults in Group C will be given standard TIV. All participants will receive a single dose of their assigned influenza vaccine, either by intramuscular (IM) injection (TIV) or intranasal application (LAIV).

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Conditions studied

  • Influenza

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Keywords

  • Inactivated influenza vaccine
  • Live, attenuated influenza vaccine
  • Child identical twins and non-twins
  • Young and elderly non-twin adults
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In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 91 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy, ambulatory 8-17 year old identical twins, 8-30 year old non-twins, or 70-100 year old elderly non-twin adults.
  2. Willing to complete the informed consent process.
  3. Availability for follow-up for the planned duration of the study at least 28 days after immunization.
  4. Acceptable medical history by medical history and vital signs.

Exclusion criteria

Exclusion Criteria:

  1. Prior vaccination with seasonal TIV or LAIV or H1N1.
  2. Prior off-study vaccination with the current seasonal TIV or LAIV
  3. Allergy to egg or egg products, or to vaccine components
  4. Life-threatening reactions to previous influenza vaccinations
  5. Asthma or history of wheezing
  6. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  7. History of immunodeficiency (including HIV infection)
  8. 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.
  9. Blood pressure >150 systolic or >95 diastolic at first study visit
  10. Hospitalization in the past year for congestive heart failure or emphysema.
  11. Chronic Hepatitis B or C.
  12. 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 except for non-LAIV Group C only). Use of oral steroids (\<20mg prednisone-equivalent/day) may be acceptable for volunteers 70-100 yrs of age after review by the investigator.
  13. Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (Groups A and B only)
  14. 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).
  15. 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.
  16. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  17. 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.
  18. Receipt of blood or blood products within the past 6 months
  19. Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
  20. Inactivated vaccine 14 days prior to vaccination
  21. Live, attenuated vaccine within 60 days of vaccination
  22. History of Guillain-Barré Syndrome
  23. Pregnant or lactating woman
  24. Use of investigational agents within 30 days prior to enrollment
  25. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
  26. 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.
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Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
91 participants (actual)

Study arms

  • Other
    Group A: 8-17 yo identical twins

    Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair

    Biological: Fluzone · Biological: FluMist

  • Other
    Group B: 8-30 yo non-twin

    Group B: 8-30 years old non-twin individuals randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))

    Biological: Fluzone · Biological: FluMist

  • Other
    Group C: 70-100 yo non-twin

    Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))

    Biological: Fluzone

Interventions

  • BiologicalFluzone

    Influenza Virus Vaccine Suspension for Intramuscular Injection

  • BiologicalFluMist

    Influenza Virus Vaccine Live, Intranasal Intranasal Spray

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What researchers measure

Primary outcomes

  1. Number of Participants Who Received Influenza Vaccine

    Time frame: Day 0 to 28

Secondary outcomes

  1. Number of Participants With Related Adverse Events

    Time frame: Day 0 to 28 post-immunization

Other outcomes

  1. Investigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses.

    Time frame: Day 0 to 28

07

Results

Posted Mar 9, 2017

Participant flow

Participant flow — Overall Study
MilestoneGroup A: 8-17 yo Identical TwinsGroup B: 8-30 yo Non-twinGroup C: 70-100 yo Non-twin
Started144136
Completed143836
Not completed030

Outcome measures

PrimaryNumber of Participants Who Received Influenza Vaccine
Time frame:
Day 0 to 28
Reported as:
Count of participants · Participants
Number of Participants Who Received Influenza Vaccine
ParticipantsGroup A: 8-17 yo Identical TwinsGroup B: 8-30 yo Non-twinGroup C: 70-100 yo Non-twin
Number of Participants Who Received Influenza Vaccine143836
SecondaryNumber of Participants With Related Adverse Events
Time frame:
Day 0 to 28 post-immunization
Reported as:
Count of participants · Participants
Number of Participants With Related Adverse Events
ParticipantsGroup A: 8-17 yo Identical TwinsGroup B: 8-30 yo Non-twinGroup C: 70-100 yo Non-twin
Number of Participants With Related Adverse Events111
Other pre-specifiedInvestigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses.
Time frame:
Day 0 to 28

Results for this outcome have not been posted.

Adverse events

Collected over Day 0 to Day 28 of study participation. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group A: 8-17 yo Identical Twins—0/14 (0%)1/14 (7.1%)
Group B: 8-30 yo Non-twin—0/38 (0%)1/38 (2.6%)
Group C: 70-100 yo Non-twin—0/36 (0%)1/36 (2.8%)
Most frequent other events
Most frequent other events
EventGroup A: 8-17 yo Identical TwinsGroup B: 8-30 yo Non-twinGroup C: 70-100 yo Non-twin
SyncopeNervous system disorders1/140/380/36
Light headednessNervous system disorders0/141/381/36

Baseline characteristics

Age, Continuous
Age, Continuous(years)Group A: 8-17 yo Identical TwinsGroup B: 8-30 yo Non-twinGroup C: 70-100 yo Non-twinTotal
Mean12.84 ± 3.5321.82 ± 5.3277.00 ± 5.31342.27 ± 28.86
Sex: Female, Male
Sex: Female, Male(Participants)Group A: 8-17 yo Identical TwinsGroup B: 8-30 yo Non-twinGroup C: 70-100 yo Non-twinTotal
Female10232154
Male4181537
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group A: 8-17 yo Identical TwinsGroup B: 8-30 yo Non-twinGroup C: 70-100 yo Non-twinTotal
Hispanic or Latino2507
Not Hispanic or Latino12363684
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group A: 8-17 yo Identical TwinsGroup B: 8-30 yo Non-twinGroup C: 70-100 yo Non-twinTotal
American Indian or Alaska Native0000
Asian013013
Native Hawaiian or Other Pacific Islander0000
Black or African American0202
White12223670
More than one race2204
Unknown or Not Reported0202
Region of Enrollment
Region of Enrollment(participants)Group A: 8-17 yo Identical TwinsGroup B: 8-30 yo Non-twinGroup C: 70-100 yo Non-twinTotal
United States14413691
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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Sasaki S, Holmes TH, Albrecht RA, Garcia-Sastre A, Dekker CL, He XS, Greenberg HB. Distinct cross-reactive B-cell responses to live attenuated and inactivated influenza vaccines. J Infect Dis. 2014 Sep 15;210(6):865-74. doi: 10.1093/infdis/jiu190. Epub 2014 Mar 27. PubMed 24676204 ↗
  • He XS, Holmes TH, Sanyal M, Albrecht RA, Garcia-Sastre A, Dekker CL, Davis MM, Greenberg HB. Distinct patterns of B-cell activation and priming by natural influenza virus infection versus inactivated influenza vaccination. J Infect Dis. 2015 Apr 1;211(7):1051-9. doi: 10.1093/infdis/jiu580. Epub 2014 Oct 21. PubMed 25336731 ↗
  • Brodin 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 25594173 ↗
  • de 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03020498
Lead sponsor
Stanford University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Cornelia L. Dekker (Study Principal Investigator, Stanford University) — Principal investigator
First posted
Jan 13, 2017
Start date
Sep 2010
Primary completion
Dec 2011
Completion
Dec 2011
Results posted
Mar 9, 2017
Last update
Jun 6, 2018

Study contacts

Cornelia Dekker, MD
principal investigator · Stanford University
Harry Greenberg, MD
principal investigator · Stanford University
Stephen Quake, PhD
principal investigator · Stanford University
Xiaosong He, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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