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The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection (SLVP030)

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ClinicalTrials.gov Identifier: NCT03453801
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Brief Summary:
The purpose of this study is provide a better understanding of the adaptive immune response to the licensed influenza vaccines in children.

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

Detailed Description:

This is a Phase IV study of up to 100 healthy children, ages 6 months to 10 years of age, who will receive either Flumist® live, attenuated influenza virus vaccine, quadrivalent (LAIV4) or the current Fluzone® inactivated influenza vaccine, quadrivalent (IIV4). The volunteers will be enrolled into one of 3 Groups (A, B, C). Volunteers will return each year until 2018-2019 for annual flu immunizations and study visits. Questionnaires will be administered annually to record demographic characteristics, vaccination history, exposure to animals, day care and medically attended illness. There are no exclusions for gender, ethnicity or race.

Volunteers in Group C will also receive the measles, mumps, rubella and varicella (MMRV) vaccine at approximately 12-15 months of age (to be administered by the volunteers' personal pediatrician, not as a study vaccine). They will then come for a study visit to collect blood 60 days later.

Each twin is counted as a single participant. All reporting numbers reflect the number of participants, not the number of twin pairs.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection
Actual Study Start Date : August 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Memory

Arm Intervention/treatment
Experimental: Group A: MZ twins 2-5 years (LAIV4)
Group A Monozygotic twins, 2-5 yo (annual return): Individual twin participants will be given FluMist® a live, attenuated influenza vaccine quadrivalent (LAIV4) intranasally. Vaccine non-naive participants will return annually for flu immunization and for blood samples on Days 0, 7 and 60 post-immunization. Vaccine naive children will receive two immunizations in the first year, 28 days apart then return annually for flu immunization. Blood samples will be obtained on Days 0, 7 and 60 post second-immunization. Beginning in 2015-2016, participants in Group A will receive Fluzone® inactivated influenza vaccine quadrivalent (IIV4) following ACIP recommendation not to give LAIV4.
Biological: Fluzone®
Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine): The pediatric dose (6-35 months) will be supplied in a prefilled, single dose syringe, 0.25 mL (no preservative). Each 0.5 mL dose of Fluzone® Quadrivalent (36 months-adult) will be supplied in a prefilled, single dose syringe, 0.5 mL (no preservative). Both formulations given IM.
Other Name: IIV4

Biological: FluMist®
FluMist® Quadrivalent: live, attenuated influenza virus vaccine quadrivalent, given by intranasal spray
Other Name: LAIV4

Experimental: Group B: 6 mo-10 yr (IIV4 or LAIV4)
Group B non-twins 6 mo-10 years (annual return): Participants between 6-23 mo, and 9-10 yr will be given Fluzone® inactivated influenza vaccine quadrivalent (IIV4) IM. Participants 2-8 yr will be given FluMist® live, attenuated influenza vaccine quadrivalent (LAIV4) intranasally. Vaccine non-naive participants will return annually for flu immunization and for blood samples on Days 0 and 60 post immunization. Vaccine naive children will get two doses of vaccine the first yr then return annually for flu immunization and blood samples on Day 0 and 60 post second immunization. Beginning in 2015-2016 all participants in Group B 6 mo through10 yr will receive Fluzone® inactivated influenza vaccine quadrivalent (IIV4) following ACIP recommendation not to give LAIV4.
Biological: Fluzone®
Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine): The pediatric dose (6-35 months) will be supplied in a prefilled, single dose syringe, 0.25 mL (no preservative). Each 0.5 mL dose of Fluzone® Quadrivalent (36 months-adult) will be supplied in a prefilled, single dose syringe, 0.5 mL (no preservative). Both formulations given IM.
Other Name: IIV4

Biological: FluMist®
FluMist® Quadrivalent: live, attenuated influenza virus vaccine quadrivalent, given by intranasal spray
Other Name: LAIV4

Experimental: Group C: 6-12 mo Flu/MMRV Naïve (IIV4)
Group C non-twins 6-12 mo (annual return): Participants 6-12 mo who are flu and MMRV naïve will be given Fluzone® inactivated influenza vaccine quadrivalent (IIV4) annually. In Year 1, participants will return for a second flu immunization at least 28 days later and for blood samples on Days 0 and 60 post-second immunization and on Day 60 post MMRV (to be given by primary care physician). In Years 2-5, participants will return annually for Fluzone® IIV4 flu immunization and for blood samples on Days 0 and 60 post-immunization.
Biological: Fluzone®
Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine): The pediatric dose (6-35 months) will be supplied in a prefilled, single dose syringe, 0.25 mL (no preservative). Each 0.5 mL dose of Fluzone® Quadrivalent (36 months-adult) will be supplied in a prefilled, single dose syringe, 0.5 mL (no preservative). Both formulations given IM.
Other Name: IIV4




Primary Outcome Measures :
  1. Hemagglutination inhibition (HAI) titers [ Time Frame: 0-60 days ]
    Evaluate HAI titers in response to influenza vaccination.


Secondary Outcome Measures :
  1. Related adverse events (AEs) [ Time Frame: 0 to 32 days post immunization ]
    Number of participants with related adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Otherwise healthy non-twins 6 months - 10 years old, or 2-5 year old identical (MZ) twins.
  2. Willing to complete the informed consent process (including assent for minors 7 years old and above).
  3. Availability for follow-up for the planned duration of the study - annually until 2018-2019 influenza vaccination season
  4. Acceptable medical history by review of inclusion/exclusion criteria and vital signs.
  5. Group C only: Willing to have primary care physician immunize child with the MMRV vaccine and return for a study visit approximately 60 days later.

Exclusion Criteria:

  1. Prior off-study vaccination with the current year's seasonal influenza vaccine.
  2. Life-threatening reactions to previous influenza vaccinations
  3. Allergy to egg or egg products, or to vaccine components
  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 systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in all groups; inhaled steroid use is not permissible)
  9. Malignancy
  10. 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.
  11. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  12. Receipt of blood or blood products within the past 6 months or planned used during the study.
  13. Receipt of Inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last study visit ( ~ 28 Day after study vaccination)
  14. Receipt of live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 28 Day after study vaccination)
  15. Need for allergy immunization (that cannot be postponed) during the study period.
  16. History of Guillain-Barré syndrome
  17. Use of investigational agents within 30 days prior to enrollment or planned use during the study.
  18. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned donation prior to completion of the last visit.
  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.

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): NCT03453801


Contacts
Contact: Stanford University Stanford-LPCH Vaccine Program 6504987284 vaccines_program@stanford.edu
Contact: Cornelia Dekker, MD 650-724-4437 cdekker@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: Cornelia L Dekker, MD    650-724-4437    cdekker@stanford.edu   
Contact: , PhD         
Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Cornelia L Dekker, MD Stanford University
Principal Investigator: Mark M Davis, PhD Stanford University

Responsible Party: Cornelia L. Dekker, Professor of Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT03453801     History of Changes
Other Study ID Numbers: SU-31256
U19AI057229-11 ( U.S. NIH Grant/Contract )
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cornelia L. Dekker, Stanford University:
Inactivated, influenza vaccine quadrivalent
Live, attenuated influenza vaccine quadrivalent
Young children
Identical twins

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