A Study of the Immunogenicity of BCG, Delivered Intradermally in Healthy Volunteers
A Study of the Immunogenicity of M. Bovis BCG (SSI Strain), Delivered Intradermally in Healthy Volunteers
調査の概要
詳細な説明
Volunteers for the study will be recruited through advertisements. Each volunteer will have received an information sheet concerning the study and will have agreed to participate in writing.
Volunteers will be given at least 48 hours between reading the information leaflet and agreeing to participate. Female volunteers will have a pregnancy test prior to enrollment. Volunteers will give signed consent for their GP's to be notified about their participation in the trial. The GP will be faxed a letter on the day of screening and asked to reply if they know of a reason why the volunteer should not take part. The signed consent form will also be faxed with the letter.
A week after the screening visit and after a negative Heaf test, subjects will receive a single intradermal injection of 106 cfu M. bovis BCG in 0.1ml just inferior to the insertion of the deltoid muscle. Blood tests will be taken at the screening visit and day of immunisation, 1 and 2 weeks, and 1, 2, 3 and 6 months after the immunisation. 75mls will be taken on the screening visit, and 60mls will be taken on all subsequent visits. Screening samples will be tested for full blood count, biochemical screen and immunological assays to determine vaccine immunogenicity. Peripheral blood mononuclear cells will be prepared for cellular immunological assays to be performed without or following cryopreservation. Other serological measures of immune response, i.e.
antibody titres, will be assayed on frozen plasma samples. All blood tests will be taken within 1-3 days of the due date as described in the schedule above.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Oxfordshire
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Oxford、Oxfordshire、イギリス、OX3 7LJ
- University of Oxford, CCVTM, Churchill 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 adult aged 18-65 years.
- Normal medical history and physical examination.
- Normal urine dipstick, blood count, liver enzymes, and creatinine.
Exclusion Criteria:
- Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
- Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
- Oral or systemic steroid medication or the use of immunosuppressive agents.
- Positive HIV or core HBV antibody test.
- Positive Heaf test
- Positive ANA or serum anti-DNA antibody.
- Confirmed pregnancy
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:防止
- 割り当て:なし
- 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)
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 |
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The induction of T-cell responses
時間枠:6 months
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6 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Helen I McShane、University of Oxford
出版物と役立つリンク
一般刊行物
- McShane H, Pathan AA, Sander CR, Keating SM, Gilbert SC, Huygen K, Fletcher HA, Hill AV. Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med. 2004 Nov;10(11):1240-4. doi: 10.1038/nm1128. Epub 2004 Oct 24. Erratum In: Nat Med. 2004 Dec;10(12):1397.
- Pathan AA, Sander CR, Fletcher HA, Poulton I, Alder NC, Beveridge NE, Whelan KT, Hill AV, McShane H. Boosting BCG with recombinant modified vaccinia ankara expressing antigen 85A: different boosting intervals and implications for efficacy trials. PLoS One. 2007 Oct 24;2(10):e1052. doi: 10.1371/journal.pone.0001052. Erratum In: PLoS One. 2011;6(2).doi:10.1371/annotation/71208a01-eb32-469c-96ab-8d5e3c497fce.
研究記録日
主要日程の研究
研究開始
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 (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
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。
結核の臨床試験
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National Institute of Allergy and Infectious Diseases...完了
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Far Eastern Memorial Hospitalわからない
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Centre for the AIDS Programme of Research in South...Amsterdam Institute for Global Health and Development; Global Alliance for TB Drug Development; Foundation for Innovative New Diagnostics, Switzerland と他の協力者募集
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Riverside University Health System Medical Centerわからない
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Global Alliance for TB Drug Development完了結核 | 結核、肺 | 結核、多剤耐性 | 広範囲にわたる薬剤耐性結核 | 結核、MDR | XDR-TB | XDR-TB以前南アフリカ, ロシア連邦, グルジア, モルドバ共和国
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Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID); Dr. D.Y. Patil Medical College...募集
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GlaxoSmithKline完了
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Boston CollegeBoston University; National Institute of Nursing Research (NINR); National Institutes of Health... と他の協力者まだ募集していません
BCG (SSI Strain)の臨床試験
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Bandim Health ProjectUniversity of Southern Denmark募集
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Bandim Health ProjectOdense University Hospital; Odense Patient Data Explorative Network; Municipality of Odense完了
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TASK Applied Science完了