Protective Mechanisms Against a Pandemic Respiratory Virus: B-cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 4, 2012
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Stanford University
- Enrollment
- 22
- Primary Endpoint
- Number of Participants Who Received Influenza Vaccine
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 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. On an investigational basis, 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. Twin group B will will be randomly assigned to receive a single dose of inactivated vaccine, either the trivalent inactivated influenza vaccine (TIV) or intranasal live, attenuated influenza vaccine (LAIV). Twin Groups C-E will receive a single administration of TIV. Group F, elderly participants, will be randomly assigned to receive a single dose of inactivated vaccine, either the standard dose or the high-dose TIV. Blood samples to conduct the assays described will be taken at pre-immunization, Days 7-10 and 28 post-immunization. Groups A, C and E were not enrolled for this year of the five year annual study.
Investigators
Cornelia L. Dekker
Professor, Pediatrics
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Otherwise healthy, ambulatory adults, ages 18-30 years (identical or fraternal twin pairs), 40-64 years (identical or fraternal twin pairs) or 65-100 years (identical twin pairs).
- •Willing to complete the informed consent process.
- •Availability for follow-up for the planned duration of the study at least 28 days after immunization.
- •Acceptable medical history and vital signs.
Exclusion Criteria
- •Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) in Fall 2012
- •Allergy to egg or egg products, or to vaccine components (including gentamicin, gelatin, arginine or MSG (LAIV for Group B only), and thimerosal (if TIV multidose vials used)
- •Life-threatening reactions to previous influenza vaccinations
- •Active systemic or serious concurrent illness, including febrile illness 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.
- •Blood pressure \>150 systolic or \> 95 diastolic at Visit 1
- •Hospitalization in the past year for congestive heart failure or emphysema.
- •Chronic Hepatitis B or C
- •Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays, topical steroids and inhaled steroids are permissible). Use of oral steroids (\<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
Outcomes
Primary Outcomes
Number of Participants Who Received Influenza Vaccine
Time Frame: Day 0
Secondary Outcomes
- Number of Participants With Related Adverse Events(Day 0 to 28 post-immunization)