Overview

This trial is active, not recruiting.

Condition influenza,
Treatments fluzone® (intramuscular), flumist® (intranasal), fluzone® high-dose (intramuscular)
Phase phase 4
Sponsor Stanford University
Collaborator National Institute of Allergy and Infectious Diseases (NIAID)
Start date July 2009
End date January 2014
Trial size 550 participants
Trial identifier NCT01987349, 5U19AI057229-07, SU-17219

Summary

This study will investigate markers, mechanisms and define general predictors for immunological health. This goal is analogous to what has been achieved in cardiovascular medicine where the levels of different forms of cholesterol have provided useful benchmarks for cardiovascular health. In this context, immunization with FDA approved flu vaccines represents a safe and accessible opportunity to gauge the immune response in a particular individual as a function of age and genetics and then to try to find predictive biomarkers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Participants will be randomized to receive either Fluzone® (intramuscular) or Flumist® (intranasal)
fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
flumist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
(Experimental)
Participants to receive either Fluzone® (intramuscular) or Flumist® (intranasal)
fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
flumist® (intranasal)
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
(Experimental)
Participants will receive Fluzone® (intramuscular)
fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
(Experimental)
Participants will be randomized to receive either Fluzone® or Fluzone® High-Dose (both are intramuscular)
fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
fluzone® high-dose (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3) High-Dose
(Experimental)
Participants will receive Fluzone® (intramuscular)
fluzone® (intramuscular)
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)

Primary Outcomes

Measure
HAI antibody response to annual influenza vaccination
time frame: Baseline to Day 28

Secondary Outcomes

Measure
Levels of different serum cytokines
time frame: Baseline to Day 6-14
Lymphocyte response to influenza immunization
time frame: Day 6-28 post-immunization

Eligibility Criteria

Male or female participants at least 1 year old.

Inclusion Criteria: - Otherwise healthy, 1-17 years (twin pairs), 18-30 years (twin pairs), 40-64 years (twin pairs) or 65-100 years (twins and non-twins). - 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 IIV or LAIV in the current flu season - Allergy to egg or egg products, or to vaccine components (including gentamicin, gelatin, arginine or MSG (LAIV volunteers only), and thimerosal (if IIV 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. - Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia). - 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 - Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except aspirin up to 325 mg.day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety. - Receipt of blood or blood products within the past 6 months or planned receipt of blood products prior to completion of study visits. - Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol - Receipt of inactivated vaccine 14 days prior to study vaccination, or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination) - Receipt of live, attenuated vaccine within 30 days of vaccination, or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination) - Need for allergy immunization (that cannot be postponed) during the study period V01 to V03 (~Day 28) - History of Guillain-Barré Syndrome - Pregnant or lactating woman - Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits. - Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned blood donation prior to completion of Visit 03 ( ~28 Day after study vaccination) - A current member of the clinical study team. - 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. - Asthma or history of wheezing (for volunteers receiving LAIV only) - Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (for volunteers receiving LAIV only)

Additional Information

Official title Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus Research Project 2: T-cell and General Immune Responses to Influenza; Research Project 3: Single-cell Phospho-protein Signaling Analysis of the Response to Influenza Vaccination; Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire
Principal investigator Cornelia L Dekker, M.D
Description 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. This work may help in the improved design of new vaccines, both for influenza and for other respiratory pathogens as well.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Stanford University.