T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012
Protective Mechanisms Against a Pandemic Respiratory Virus: B-cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 4, 2012
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
- 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 60 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-Barre 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 Group B volunteers only)
- Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (for Group B volunteers only)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
他の:Group B: 18-30 yo identical twins (LAIV)
Participants to receive FluMist® LAIV by nasal spray.
|
Live, attenuated influenza vaccine for Intranasal Spray
他の名前:
|
他の:Group B: 18-30 yo identical twins (TIV)
Participants to receive Fluzone® standard TIV
|
筋肉注射用インフルエンザウイルスワクチン懸濁液
他の名前:
|
他の:Group D: 40-64 yo identical twins (TIV)
Participants to receive Fluzone® standard TIV
|
筋肉注射用インフルエンザウイルスワクチン懸濁液
他の名前:
|
他の:Group F: 65-100 yo identical twins (TIV)
Participants to receive Fluzone® standard TIV
|
筋肉注射用インフルエンザウイルスワクチン懸濁液
他の名前:
|
他の:Group F: 65-100 yo identical twins (High-Dose TIV)
Participants to receive High-Dose Fluzone® standard TIV
|
High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
インフルエンザワクチン接種者数
時間枠:0日目
|
0日目
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
関連する有害事象のある参加者の数
時間枠:免疫後0~28日目
|
免疫後0~28日目
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Mark Davis, PhD、Stanford University
- 主任研究者:Garry Nolan, PhD、Stanford University
- 主任研究者:Ann Arvin, MD、Stanford University
出版物と役立つリンク
一般刊行物
- Kay AW, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Holmes S, Blish CA. Enhanced natural killer-cell and T-cell responses to influenza A virus during pregnancy. Proc Natl Acad Sci U S A. 2014 Oct 7;111(40):14506-11. doi: 10.1073/pnas.1416569111. Epub 2014 Sep 22.
- Kay AW, Bayless NL, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Blish CA. Pregnancy Does Not Attenuate the Antibody or Plasmablast Response to Inactivated Influenza Vaccine. J Infect Dis. 2015 Sep 15;212(6):861-70. doi: 10.1093/infdis/jiv138. Epub 2015 Mar 4.
- O'Gorman WE, Huang H, Wei YL, Davis KL, Leipold MD, Bendall SC, Kidd BA, Dekker CL, Maecker HT, Chien YH, Davis MM. The Split Virus Influenza Vaccine rapidly activates immune cells through Fcgamma receptors. Vaccine. 2014 Oct 14;32(45):5989-97. doi: 10.1016/j.vaccine.2014.07.115. Epub 2014 Sep 6.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SU-17219-2012
- 2U19AI057229-06 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
TIVの臨床試験
-
Stanford UniversityNational Institute of Allergy and Infectious Diseases (NIAID)完了
-
Immune Targeting Systems Ltd完了
-
Novartis Vaccines完了
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Stanford UniversityNational Institute of Allergy and Infectious Diseases (NIAID)完了
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BiondVax Pharmaceuticals ltd.完了
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National Institute of Allergy and Infectious Diseases...The Emmes Company, LLC完了