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

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ClinicalTrials.gov Identifier: NCT03020498
Recruitment Status : Completed
First Posted : January 13, 2017
Results First Posted : March 9, 2017
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluzone Biological: FluMist Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza. Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire - Years 2 (2010) & 3 (2011)
Study Start Date : September 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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
Influenza Virus Vaccine Suspension for Intramuscular Injection

Biological: FluMist
Influenza Virus Vaccine Live, Intranasal Intranasal Spray

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
Influenza Virus Vaccine Suspension for Intramuscular Injection

Biological: FluMist
Influenza Virus Vaccine Live, Intranasal Intranasal Spray

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
Influenza Virus Vaccine Suspension for Intramuscular Injection




Primary Outcome Measures :
  1. Number of Participants Who Received Influenza Vaccine [ Time Frame: Day 0 to 28 ]

Secondary Outcome Measures :
  1. Number of Participants With Related Adverse Events [ Time Frame: Day 0 to 28 post-immunization ]

Other Outcome Measures:
  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 ]


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Ages Eligible for Study:   8 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020498


Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Cornelia Dekker, MD Stanford University
Principal Investigator: Harry Greenberg, MD Stanford University
Principal Investigator: Stephen Quake, PhD Stanford University
Principal Investigator: Xiaosong He, PhD Stanford University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cornelia L. Dekker, Study Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03020498     History of Changes
Other Study ID Numbers: SU-17218-2010-2011
2U19AI057229-06 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2017    Key Record Dates
Results First Posted: March 9, 2017
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cornelia L. Dekker, Stanford University:
Inactivated influenza vaccine
Live, attenuated influenza vaccine
Child identical twins and non-twins
Young and elderly non-twin adults

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs