T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009

Study Overview
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Brief Summary
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This study will compare influenza vaccine responses in monozygotic and dizygotic twins.

Detailed Description
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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.

Official Title
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Protective Mechanisms Against a Pandemic Respiratory Virus: B- Cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 1, 2009

Conditions
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Influenza

Intervention / Treatment
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* Biological: Fluzone® (intramuscular)
* Biological: FluMist® (intranasal)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Otherwise healthy, ambulatory children or adults, ages 8-17 years (identical twin pairs), 18-30 years (identical or fraternal twin pairs), 40-49 years (identical or fraternal twin pairs) or 70-100 years (twin or non-twin adults). 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. Negative urine pregnancy test for women of childbearing potential If the subject is female and of childbearing potential, she must use an acceptable method of contraception and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner). Exclusion Criteria: Prior vaccination with TIV or LAIV in Fall 2009 Allergy to egg or egg products, or to vaccine components, including gentamicin, gelatin, arginine or MSG (for LAIV only), or thimerosal (TIV multidose vials only). Life-threatening reactions to previous influenza vaccinations Asthma (LAIV groups only) Active systemic or serious concurrent illness, including febrile illness on the day of vaccination History of immune deficiency 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, blood pressure >150/95 at screening, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol. 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 are permissible). Subjects in close contact with anyone who has a severely weakened immune system should not receive LAIV. 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, Plavix, Aggrenox may be acceptable after review by investigator. Receipt of blood or blood products within the past 6 months Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol Inactivated vaccine 14 days prior to vaccination Live, attenuated vaccine within 60 days of vaccination History of Guillain-Barre Syndrome Pregnant or lactating woman Use of investigational agents within 30 days prior to enrollment Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment 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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 100 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A: age 8-17 yo identical twins<br>Participants will be randomized to receive either Fluzone® (intramuscular) or FluMist® (intranasal) | Biological: Fluzone® (intramuscular)<br>* Licensed seasonal trivalent inactivated influenza vaccine (IIV3)<br>Biological: FluMist® (intranasal)<br>* Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)<br>|
| Other: Group B: 18-30 yo identical twins<br>Participants to receive FluMist® (intranasal) | Biological: FluMist® (intranasal)<br>* Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)<br>|
| Other: Group C: 18-30 yo fraternal twins<br>Participants to receive FluMist® (intranasal) | Biological: FluMist® (intranasal)<br>* Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)<br>|
| Other: Group D: 40-49 yo identical twins<br>Participants to receive FluMist® (intranasal) | Biological: FluMist® (intranasal)<br>* Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)<br>|
| Other: Group E: 40-49 yo fraternal twins<br>Participants to receive FluMist® (intranasal) | Biological: FluMist® (intranasal)<br>* Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)<br>|
| Other: Group F: 70-100 yo twins<br>Participants to receive Fluzone® (intramuscular) | Biological: Fluzone® (intramuscular)<br>* Licensed seasonal trivalent inactivated influenza vaccine (IIV3)<br>|
| Other: Group G: 70-100 yo non-twins<br>Participants to receive Fluzone® (intramuscular) | Biological: Fluzone® (intramuscular)<br>* Licensed seasonal trivalent inactivated influenza vaccine (IIV3)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine |  | Day 0 to 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Related Adverse Events |  | Day 0 to 28 post-immunization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza vaccines, healthy participants, immunity to influenza, identical twins, fraternal twins, non-twins