Influenza Clinical Trial
Official title:
Understanding How the Initial Encounter With Influenza Virus Poises Children for Protective Immunity
NCT number | NCT02559505 |
Other study ID # | RSRB00058437 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | July 3, 2020 |
Verified date | August 2021 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates how different methods of early exposure to influenza (natural infection, live attenuated influenza vaccination, inactivated influenza vaccination) initially stimulate immunity and poise the immune system to respond to a future challenge with the inactivated influenza vaccine.
Status | Completed |
Enrollment | 134 |
Est. completion date | July 3, 2020 |
Est. primary completion date | July 3, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Months to 8 Years |
Eligibility | Inclusion Criteria: - Age - Between 6 and 12 months to participate in the vaccination arm of cohort 1 (cohort 1A) - Between 3 and 12 months to participate in the natural infection arm of cohort 1 (cohort 1B) - Between 13 and 35 months of age to participate in either the vaccination or natural infection arm of cohort 2 - Between 36 months and 5 years of age to participate in either the vaccination or natural infection arm of cohort 3 - Between 6 years and 8 years of age to participate in either the vaccination or natural infection arm of cohort 4 - Gestational age of =37 weeks at birth - Parent/guardian can provide informed consent - Available for the duration of the study - History of previous IIV administration ONLY for participation in the vaccination arm of cohorts 2, 3, or 4 - Acute illness documented to be due to influenza virus ONLY for participation in the natural infection arms of cohorts 1-4 Exclusion Criteria: - Immunosuppression as a result of an underlying illness or condition (including HIV or a primary immunodeficiency syndrome) - Active neoplastic disease - Use of potentially immunosuppressive medications currently or within the past year (including chemotherapeutic agents) or chronic (>2 weeks) use of oral or inhaled steroid therapy - A diagnosis of asthma requiring chronic controller medication - Previous administration of influenza vaccine in the current influenza season ONLY for subjects receiving an influenza vaccination - Receipt of immunoglobulin or another blood product within the year prior to study enrollment - An acute illness within the previous 3 days or temperature >38o on screening EXCEPT for participation in the natural infection arms of cohorts 1-4 - A contraindication to influenza vaccination EXCEPT infants between 3 and 5 months presenting with natural influenza infection whose only contraindication is their current age |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change From Baseline to Day 10 and Day 24 in PBMC Gene Expression | Changes in PBMC gene expression patterns due to prior influenza exposure will be assessed using RNA-seq analysis | Days 10 and 24 post vaccination | |
Primary | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | % H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining | Visit 2 (day 8-14 post enrollment) | |
Primary | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | % H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining | Visit 3 (day 20-28 post enrollment) | |
Primary | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | % H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining | Visit 4 (day of vaccination year 2) | |
Primary | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | % H3 protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining | Visit 5 (day 8-14 post-vaccination year 2) | |
Primary | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | % H3 Protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining | Visit 6 (day 20-28 post-vaccination year 2) | |
Secondary | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | CD4 T cell quantity and specificity will be measured using intracellular cytokine staining. We report here the mean change in percent of cells reactive to the influenza HA protein and H3 protein. | Baseline to day 24 study year 1 | |
Secondary | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | CD4 T cell quantity and specificity will be measured using intracellular cytokine staining. We report here the mean change in percent of cells reactive to the influenza HA protein and H3 protein. | Baseline to day 24 study year 2 |
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