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

Completed · Phase 1

Conditions studied: Influenza, Healthy

In brief

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

Key facts

Study ID

NCT03453801

Run by

Stanford University

People needed

80

Starts

2014-09-30

Expected to finish

2019-01-14

Last updated by the study team

2020-02-13

Who can join

Age: 1 and older, up to 10. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Prior off-study vaccination with the current year's seasonal influenza vaccine.
• Life-threatening reactions to previous influenza vaccinations
• Allergy to egg or egg products, or to vaccine components
• Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
• History of immunodeficiency (including HIV infection)
• 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.
• Chronic Hepatitis B or C.
• 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)
• Malignancy
• 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.
• History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
• Receipt of blood or blood products within the past 6 months or planned used during the study.
• 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)
• 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)
• Need for allergy immunization (that cannot be postponed) during the study period.
• History of Guillain-Barré syndrome
• Use of investigational agents within 30 days prior to enrollment or planned use during the study.
• 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.
• 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.

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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