The Human Mucosal Immune Responses to Influenza Virus (SLVP026)
The Human Mucosal Immune Responses to Influenza Virus: A Systems Biology Approach. Innate Immune Responses to Influenza Virus in Single Human Nasal Epithelial Cells
調査の概要
詳細な説明
Using state-of-the-art technology, the investigators hope the information learned from this study will help identify and describe important factors in the early-stage development of influenza immunity and possibly lead to the development of more effective vaccines. This study will be conducted in healthy male and female volunteers 18-30 years of age who received one of two seasonal influenza vaccine types, intramuscular standard trivalent inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV) given by intranasal spray.
Participants are divided into two groups. The control group will receive the 2012-2013 formulation of the standard intramuscular trivalent inactivated influenza vaccine (TIV). A blood sample and nasopharyngeal swab samples (one from each nostril) will be collected at a single visit, Day 0. For those in the live, attenuated influenza vaccine (LAIV) group, at the first visit, they will receive a single administration of the 2012-2013 formulation of LAIV. At the second study visit two days later, they will provide a blood sample and two nasopharyngeal swab samples (one from each nostril).
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 adult between the ages of 18-30 years
- Willing to complete the informed consent process.
- Availability for follow-up at Day 2 (LAIV Group only)
- Acceptable medical history by review of inclusion/exclusion criteria and vital signs.
Exclusion Criteria:
- Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV
- Allergy to egg or egg products, or to vaccine components, including thimerosal (TIV multidose vials only), or gentamicin, gelatin, arginine or MSG (for LAIV only).
- Life-threatening reactions to previous influenza vaccinations
- Asthma or history of wheezing (except for controls in the study who will be assigned to receive TIV).
- Active systemic or serious concurrent illness, including febrile illness on 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 first study visit
- Hospitalization in the past year for congestive heart failure or emphysema.
- Chronic Hepatitis B or C.
- Recent or current use of immunosuppressive medication, including systemic glucocorticoids. Corticosteroid nasal sprays for allergies and topical steroids are permissible. Inhaled steroids for conditions such as asthma are not permissible for volunteers in the LAIV group.
- Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (LAIV Group only).
- 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 up to 325 mg. aspirin per 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 of planned used during the study.
- Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination prior to completion of the last study visit.
- Live, attenuated vaccine within 60 days of vaccination or planned non-study vaccination prior to completion of the last study visit.
- 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 donation prior to completion of the last visit.
- 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.
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:TIV Group
Healthy adult males and females, 18-30 years of age.
Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
|
Influenza Virus Vaccine Suspension for Intramuscular Injection
|
他の:LAIV Group
Healthy adult males and females, 18-30 years of age.
Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
|
インフルエンザウイルス生ワクチン 鼻腔内スプレー
|
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を接種した各アームの参加者数
時間枠:0日目~28日目
|
0日目~28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:Xiaosong He, PhD、Stanford Universityh
研究記録日
主要日程の研究
研究開始
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-25537
- U19AI090019 (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?
IPD プランの説明
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。
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