Safety/Immunogenicity of Immunizations of ALVAC-DC-SC vs ALVAC-SC
A Phase I/II Study to Evaluate the Safety and Immunogenicity of the Subcutaneous Administration of ALVAC-HIV vCP1452 Infected Autologous Dendritic Cells Versus the Subcutaneous Administration of ALVAC-HIV vCP1452 To HIV-Infected Subjects
The purpose of this study is to determine how safe it is to give patients a shot that has a mixture of a vaccine and dendritic cells (DCs), a special kind of immune cell, and how safe it is to give a shot of the vaccine alone.
Current HIV vaccines have not been strong enough to give good immune responses. Research has shown that the immune response to a vaccine delivered by DCs is greater than the response without DC delivery. A5130 is a study that seeks to give good delivery of the vaccine to important immune cells of the body.
調査の概要
詳細な説明
Cytotoxic T-cell lymphocyte (CTL) responses are important in viral destruction and thereby in the protective immune response to viral infection. Current HIV vaccines do not consistently elicit strong CTL responses. The limited immune response of current HIV vaccines could be attributed, in addition to other causes, to failure of the vaccine to reach the appropriate cells to initiate a robust immune response. DCs particularly are effective in stimulating primary T-cell-dependent immunity. Antigen-bearing DCs are used as adjuvants for active immunotherapy in humans, particularly to increase host resistance to tumors and certain viral infections. A5130 is an exploratory, proof-of-concept study that seeks to ensure adequate delivery of the vaccine to important antigen-presenting cells.
Patients are randomized into 1 of 2 vaccination groups at entry. Group A: Patients receive an SC vaccination with DCs infected with ALVAC-HIV vCP1452. DC exposure to KLH occurs at Weeks 3 and 7. Leukopheresis occurs at entry.
Group B: Patients receive an SC vaccination with ALVAC-HIV vCP1452 without DCs. KLH injections are administered at Weeks 3 and 7.
Patients in both groups receive their vaccinations at Weeks 3, 7, and 15. This study consists of 4 steps but not all patients necessarily qualify to enter Step II, Step III, or Step IV.
Step I: vaccination phase. Step II: withdrawal of potent ART. Step III: optional discontinuation of ART. Step IV: reinitiation of ART. [AS PER AMENDMENT 04/10/02: Step V: follow-up period off potent ART.]
研究の種類
段階
- フェーズ 1
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital ACTG CRS
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New York
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New York、New York、アメリカ、10003
- Beth Israel Med. Ctr., ACTU
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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
Patients may be eligible for this study if they:
- Are HIV-infected.
- Took 3 or more anti-HIV drugs for 3 or more months before study entry.
- Have a viral load of 400 copies/ml or less for a period of 3 months before study start and within 30 days before study start.
- Have a CD4 count of 400 cells/mm3 or more for a period of 3 months before study start and within 30 days before study start.
- Have a CD4 count of 400 cells/mm3 or more at study screening.
- Have a viral load of 50 copies/ml or less at study screening.
- Are at least 18 years old.
- Agree not to become pregnant or to impregnate during the study and for 12 weeks after the study, if able to have children.
Exclusion Criteria
Patients may not be eligible for this study if they:
- Have a short-term but intense infection or serious illness within 14 days before study start and have not completed therapy or are not clinically stable on therapy.
- Have viral load values greater than 400 copies/ml within 3 months before study start.
- Have CD4 counts less than 400 cells/mm3 within 3 months before study start.
- Have close contact with canaries through work (e.g., breeding farms, bird shops). Does not apply to pet canaries.
- Are allergic to eggs or neomycin. Have a history of serious allergic reactions including allergy-induced asthma.
- Are sensitive or allergic to study drugs.
- Use drugs or alcohol in a way that would interfere with the patients' ability to follow the study requirements.
- Have become HIV-positive within 1 year before study start.
- Are pregnant or breast-feeding.
- Have had lymph node irradiation.
- Have had any HIV vaccine.
- Have used hydroxyurea within 45 days of study start.
- Have received drugs that affect the immune system, such as corticosteriods, within 30 days before study start.
- Are allergic to shellfish. (This study has been changed to make shellfish allergy an exclusion criterion and to remove abacavir use as an exclusion criterion.)
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：処理
- マスキング：なし（オープンラベル）
協力者と研究者
捜査官
- スタディチェア：Jeffrey Jacobson
出版物と役立つリンク
研究記録日
主要日程の研究
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
- A5130
- 10080 (DAIDS ES Registry Number)
- AACTG A5130
- ACTG A5130
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。