Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03023176
Recruitment Status : Completed
First Posted : January 18, 2017
Results First Posted : March 9, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Tracking Information
First Submitted Date  ICMJE January 13, 2017
First Posted Date  ICMJE January 18, 2017
Results First Submitted Date  ICMJE January 18, 2017
Results First Posted Date  ICMJE March 9, 2017
Last Update Posted Date April 21, 2017
Study Start Date  ICMJE September 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
Number of Participants Who Received Influenza Vaccine [ Time Frame: Day 0 to 32 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03023176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
Number of Participants With Related Adverse Events [ Time Frame: Day 0 to 32 post-immunization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013
Official Title  ICMJE Protective Mechanisms Against a Pandemic Respiratory Virus: B-cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 5, 2013
Brief Summary This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.
Detailed Description

The investigators plan to study the immune 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. 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.

The study will be conducted in healthy young identical and fraternal 1-8 year-old twins. All participants will be immunized with seasonal trivalent inactivated influenza vaccine (IIV3). Blood samples to conduct the assays described will be taken at pre-immunization, Days 6-8 and 28 post-immunization for children requiring 1 dose of vaccine. For children requiring 2 doses of vaccine, a second immunization will be given at least 28 days after Dose 1 with responses measured on Day 6-8 and Day 28-32 post-second immunization.

Children 35 months and under will receive Fluzone® standard IIV3 Pediatric Dose, while children 36 months and older will receive Fluzone® standard IIV3.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Fluzone® standard IIV3
    Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection
  • Biological: Fluzone® standard IIV3 Pediatric Dose
    Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection
Study Arms  ICMJE Healthy 1-8 year-old twins
Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.
Interventions:
  • Biological: Fluzone® standard IIV3
  • Biological: Fluzone® standard IIV3 Pediatric Dose
Publications * Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. Epub 2016 Sep 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2017)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Otherwise healthy, twin children age 1-8 years (identical or fraternal twin pairs)
  2. Parent willing to sign the informed consent form and child willing to sign assent if indicated.
  3. Availability for follow-up for the planned duration of the study at least 28 days after last immunization.
  4. Acceptable relevant medical history and vital signs.

Exclusion Criteria:

  1. Prior off-study vaccination with trivalent inactivated influenza vaccine (IIV3) or live attenuated influenza vaccine (LAIV) in Fall 2013
  2. Allergy to egg or egg products, or to vaccine components or thimerosal (if IIV3 multidose vials used)
  3. Life-threatening reactions to previous influenza vaccinations
  4. Active systemic or serious concurrent illness, including febrile illness on 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. Chronic Hepatitis B or C
  8. Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays, topical steroids are permissible). History of any cancer.
  9. 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.
  10. History of blood dyscrasias, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  11. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin.
  12. Receipt of blood or blood products within the past 6 months or planned receipt of blood products prior to completion of study visits.
  13. Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
  14. Receipt of inactivated vaccine 14 days prior to enrollment, or planned non-study vaccination prior to completion of Visit 03 or 04 (~Day 28 after the last study vaccination)
  15. Receipt of a live, attenuated vaccine within 30 days prior to first vaccination, or planned immunization with a live, attenuated vaccine before completion of study visits (inform study staff of any non-study vaccinations received during the study period).
  16. Need for allergy immunization (that cannot be postponed) during the study period.
  17. History of Guillain-Barre Syndrome
  18. Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits.
  19. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03023176
Other Study ID Numbers  ICMJE SU-17219-2013
2U19AI057229-06 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cornelia L. Dekker, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Cornelia Dekker, MD Stanford University
Principal Investigator: Mark Davis, PhD Stanford University
Principal Investigator: Garry Nolan, PhD Stanford University
Principal Investigator: Ann Arvin, MD Stanford University
Principal Investigator: Stephen Quake, PhD Stanford University
PRS Account Stanford University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP