RSV Challenge in Healthy Adults
Characterization of the Immune Response and Viral Shedding to Experimental Infection With Respiratory Syncytial Virus, Strain A-2, in Healthy Adults Ages 21 to 40 Years Old
調査の概要
詳細な説明
研究の種類
入学
段階
- 適用できない
連絡先と場所
研究場所
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New York
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Rochester、New York、アメリカ、14621
- Rochester General Hospital
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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:
Healthy adults ages 21 to 40 years. Able to and has given informed consent to participate. Negative urine pregnancy test, if female. Pre-challenge serum neutralizing titer to RSV A2 by microneutalization (MNA) of </= 1:657 (9.36 log2) Non-smoker No significant health abnormalities detected by evaluation of medical history, general physical examination, vital signs and laboratory tests.
Willingness to remain in isolation for 11 nights and comply with all study requirements.
Willingness to remain in the Rochester area for the 28 days of the study.
Exclusion Criteria:
Volunteers with any of the following conditions will not be eligible to participate:
Chronic medical conditions requiring medical followup within the last 6 months. Serologic evidence of infection with HIV or hepatitis C virus, or presence of hepatitis B surface antigen in serum.
History of medically documented asthma requiring treatment (including over-the-counter medications) at any time.
Any abnormal laboratory results which would render challenge with RSV unsafe or interfere with the interpretation of the subject's response to challenge, e.g., AST, ALT, Bilirubin, BUN, creatinine. ( see Appendix II) Individuals requiring concurrent therapy with medications likely to interfere with evaluation of the response to infection, e.g. antipyretics, anti-inflammatory medications Close contact with children aged less than 2 years, with any individuals with significant immunosuppression, or with individuals greater than 65 years of age.
Health care workers with any patient contact during the two weeks following challenge Pregnancy or uncertain status regarding pregnancy Acute respiratory infection or fever within 1 week of challenge Previous enrollment in a study evaluating RSV challenge viruses or RSV vaccines.
Known glucose intolerance (history of abnormal glucose tolerance test or medical history of diabetes mellitus).
History of chronic obstructive disease, emphysema or other serious or evolving pulmonary disease.
Any condition in the opinion of the investigator might interfere with study objectives or pose excessive risks to subjects.
History of previous hospitalization for a pulmonary condition (ie. Pneumonia, asthma, spontaneous pneumothorax, or severe sinus disease requiring a surgical procedure.
History of frequent serious bacterial infections associated with low white blood cell count (below 4,000 per microgram)
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
- 割り当て:非ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
協力者と研究者
研究記録日
主要日程の研究
研究開始
研究の完了
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 (見積もり)
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
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。
RSV challenge materialの臨床試験
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University of Maryland, BaltimoreMedical Technology Enterprise Consortium (MTEC)完了
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National Institute of Allergy and Infectious Diseases...完了
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U.S. Army Medical Research and Development CommandState University of New York - Upstate Medical University完了
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State University of New York - Upstate Medical...Walter Reed Army Institute of Research (WRAIR); U.S. Army Medical Research and Development Command完了
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State University of New York - Upstate Medical...U.S. Army Medical Research and Development Command; Janssen Pharmaceutica N.V., Belgium完了
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State University of New York - Upstate Medical...Walter Reed Army Institute of Research (WRAIR); U.S. Army Medical Research and Development Command積極的、募集していない
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GlaxoSmithKline完了
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GlaxoSmithKline完了