Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study

Study Overview
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Brief Summary
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Some people experience symptoms just after receiving the seasonal inactivated influenza vaccine. The cause of some of these symptoms is likely to be an immune response to the vaccine. The investigators would like to look at the earliest immune responses to the inactivated influenza vaccine. This pilot study will help us to determine at what time points we should look.

Official Title
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A Pilot Study to Examine the Early Cytokine Responses After Inactivated Influenza Vaccination in Adults 18-50.

Conditions
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Influenza Virus Vaccine

Intervention / Treatment
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* Biological: Trivalent Inactivated Influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-50 years. Good general health as a result of review of medical history and medications. Willingness to participate in the study as evidenced by signing informed consent document. Available for the duration of the trial. Exclusion Criteria: Known to be pregnant. Medical, behavioral, cognitive or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol. Severe allergy to eggs or any component of the influenza vaccine Previous receipt of the 2011-2012 season influenza vaccine Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol. History of receiving any investigational product within the past 30 days. Participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. History of a severe allergic reaction or anaphylaxis. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia. Known immunodeficiency syndrome. Use of chronic (≥14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e. prednisone >10 mg/ day) or immunosuppressive drugs within 30 days of starting this study. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study. History of a surgical splenectomy. Receipt of blood products within the past 6 months. Refusal to allow storage of samples for future research.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort 1<br>receives vaccine in morning. Blood drawn at 3, 7, 24, and 48 hours and 14 days after vaccination. | Biological: Trivalent Inactivated Influenza vaccine<br>* 0.5 ml IM once only<br>|
| Active Comparator: Cohort 2<br>receives vaccine in evening, Blood drawn 16, 40 hours and 14 days after vaccination. | Biological: Trivalent Inactivated Influenza vaccine<br>* 0.5 ml IM once only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine | This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days. | 0 hours, 16 hours, 24 hours, 14 days | 
| Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine | This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days. | 0 hours, 16 hours, 24 hours, 14 days | 
| Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine | This was an exploratory trial to look at the kinetics of early (1st 48 hours) cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days. | 0 hours, 16 hours, 24 hours, 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza vaccine, cytokines, chemokines, symptoms