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CompletedNCT03022435Updated May 22, 2017Results posted

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

A Phase 4 interventional study of TIV and High-Dose TIV in Influenza, sponsored by Stanford University. Completed. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-22.

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

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Oct 2012, registered Jan 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Influenza

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Keywords

  • Inactivated influenza vaccine
  • Live, attenuated influenza vaccine
  • Adult and elderly identical twins
  • Adult fraternal twins
03

In context

Influenza, Human

2,215 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 22 is below the median of 239 across 1,854 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.

04

Who can participate

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

Inclusion criteria

  1. 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).
  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 and vital signs.

Exclusion criteria

Exclusion Criteria:

  1. Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) in Fall 2012
  2. 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)
  3. Life-threatening reactions to previous influenza vaccinations
  4. Active systemic or serious concurrent illness, including febrile illness the day of vaccination
  5. History of immunodeficiency (including HIV infection)
  6. 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.
  7. Blood pressure >150 systolic or > 95 diastolic at Visit 1
  8. Hospitalization in the past year for congestive heart failure or emphysema.
  9. Chronic Hepatitis B or C
  10. 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.
  11. 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).
  12. 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.
  13. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  14. 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.
  15. Receipt of blood or blood products within the past 6 months or planned receipt of blood products prior to completion of study visits.
  16. Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
  17. 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)
  18. 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)
  19. Need for allergy immunization (that cannot be postponed) during the study period V01 to V03 (\~Day 28)
  20. History of Guillain-Barre Syndrome
  21. Pregnant or lactating woman
  22. Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits.
  23. 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)
  24. A current member of the clinical study team.
  25. 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.
  26. Asthma or history of wheezing (for Group B volunteers only)
  27. Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (for Group B volunteers only)
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Other
    Group B: 18-30 yo identical twins (LAIV)

    Participants to receive FluMist® LAIV by nasal spray.

    Biological: LAIV

  • Other
    Group B: 18-30 yo identical twins (TIV)

    Participants to receive Fluzone® standard TIV

    Biological: TIV

  • Other
    Group D: 40-64 yo identical twins (TIV)

    Participants to receive Fluzone® standard TIV

    Biological: TIV

  • Other
    Group F: 65-100 yo identical twins (TIV)

    Participants to receive Fluzone® standard TIV

    Biological: TIV

  • Other
    Group F: 65-100 yo identical twins (High-Dose TIV)

    Participants to receive High-Dose Fluzone® standard TIV

    Biological: High-Dose TIV

Interventions

  • BiologicalTIV

    Influenza Virus Vaccine Suspension for Intramuscular Injection

    Also known as: Fluzone® standard TIV

  • BiologicalHigh-Dose TIV

    High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe

    Also known as: High-Dose Fluzone® TIV

  • BiologicalLAIV

    Live, attenuated influenza vaccine for Intranasal Spray

    Also known as: FluMist®

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Received Influenza Vaccine

    Time frame: Day 0

Secondary outcomes

  1. Number of Participants With Related Adverse Events

    Time frame: Day 0 to 28 post-immunization

07

Results

Posted Mar 9, 2017

Participant flow

Numbers listed in the tables reflect individual twins and not twin pairs.

Participant flow — Overall Study
MilestoneGroup B: 18-30 yo Identical Twins (LAIV)Group B: 18-30 yo Identical Twins (TIV)Group D: 40 - 64 yo Identical TwinsGroup F: 65-100 yo Identical Twins (TIV)Group F: 65-100 yo Identical Twins (High-Dose TIV)
Started55633
Completed55633
Not completed00000

Outcome measures

PrimaryNumber of Participants Who Received Influenza Vaccine
Time frame:
Day 0
Reported as:
Count of participants · Participants
Number of Participants Who Received Influenza Vaccine
ParticipantsGroup B: 18-30 yo Identical Twins (LAIV)Group B: 18-30 yo Identical Twins (TIV)Group D: 40 - 64 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (High-Dose TIV)
Number of Participants Who Received Influenza Vaccine55633
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 B: 18-30 yo Identical Twins (LAIV)Group B: 18-30 yo Identical Twins (TIV)Group D: 40 - 64 yo Identical TwinsGroup F: 65 - 100 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (High Dose TIV)
Number of Participants With Related Adverse Events00000

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Group B: 18-30 yo Identical Twins (LAIV)0/5 (0%)0/5 (0%)0/5 (0%)
Group B: 18-30 yo Identical Twins (TIV)0/5 (0%)0/5 (0%)0/5 (0%)
Group D: 40 - 64 yo Identical Twins (TIV)0/6 (0%)0/6 (0%)0/6 (0%)
Group F: 65 - 100 yo Identical Twins (TIV)0/3 (0%)0/3 (0%)0/3 (0%)
Group F: 65 - 100 yo Identical Twins (High-Dose TIV)0/3 (0%)0/3 (0%)0/3 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Group B: 18-30 yo Identical Twins (LAIV)Group B: 18-30 yo Identical Twins (TIV)Group D: 40 - 64 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (High-Dose TIV)Total
Mean22.98 ± 4.2622.98 ± 4.2642.76 ± 1.9373.45 ± 4.2073.45 ± 4.2042.14 ± 21.63
Sex: Female, Male
Sex: Female, Male(Participants)Group B: 18-30 yo Identical Twins (LAIV)Group B: 18-30 yo Identical Twins (TIV)Group D: 40 - 64 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (High-Dose TIV)Total
Female4442216
Male112116
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group B: 18-30 yo Identical Twins (LAIV)Group B: 18-30 yo Identical Twins (TIV)Group D: 40 - 64 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (High-Dose TIV)Total
Hispanic or Latino330006
Not Hispanic or Latino2263316
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group B: 18-30 yo Identical Twins (LAIV)Group B: 18-30 yo Identical Twins (TIV)Group D: 40 - 64 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (High-Dose TIV)Total
American Indian or Alaska Native000000
Asian110002
Native Hawaiian or Other Pacific Islander110002
Black or African American000000
White2263316
More than one race110002
Unknown or Not Reported000000
Region of Enrollment
Region of Enrollment(Participants)Group B: 18-30 yo Identical Twins (LAIV)Group B: 18-30 yo Identical Twins (TIV)Group D: 40 - 64 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (TIV)Group F: 65 - 100 yo Identical Twins (High-Dose TIV)Total
United States5563322
08

Study locations

No study locations are listed for this record.

09

References and documents

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 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03022435
Lead sponsor
Stanford University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Cornelia L. Dekker (Professor, Pediatrics, Stanford University) — Principal investigator
First posted
Jan 16, 2017
Start date
Oct 2012
Primary completion
Jan 2013
Completion
Jan 2013
Results posted
Mar 9, 2017
Last update
May 22, 2017

Study contacts

Cornelia Dekker, MD
principal investigator · Stanford University
Mark Davis, PhD
principal investigator · Stanford University
Garry Nolan, PhD
principal investigator · Stanford University
Ann Arvin, MD
principal investigator · Stanford University
Stephen Quake, PhD
principal investigator · Stanford University

Oversight

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

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