T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013
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|ClinicalTrials.gov Identifier: NCT03023176|
Recruitment Status : Completed
First Posted : January 18, 2017
Results First Posted : March 9, 2017
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Fluzone® standard IIV3 Biological: Fluzone® standard IIV3 Pediatric Dose||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Protective Mechanisms Against a Pandemic Respiratory Virus: B-cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 5, 2013|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
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.
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
- Number of Participants Who Received Influenza Vaccine [ Time Frame: Day 0 to 32 ]
- Number of Participants With Related Adverse Events [ Time Frame: Day 0 to 32 post-immunization ]
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): NCT03023176
|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|