A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers
To evaluate the safety and immunogenicity of high-titered ALVAC-HIV MN120TMG (vCP205) given sequentially or simultaneously with rgp120/HIV-1SF2 in MF59 adjuvant emulsion in HIV-negative volunteers.
ALVAC-HIV vCP205 is a second-generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. vCP205 expresses proteins from two strains of HIV (MN and LAI). rgp120/HIV-1SF2 expresses proteins from a different strain of HIV. This study will help to show how the immune system responds to proteins from more than one strain of virus.
調査の概要
状態
条件
詳細な説明
ALVAC-HIV vCP205 is a second-generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. vCP205 expresses proteins from two strains of HIV (MN and LAI). rgp120/HIV-1SF2 expresses proteins from a different strain of HIV. This study will help to show how the immune system responds to proteins from more than one strain of virus.
Six groups of 25 volunteers each are randomized to receive simultaneous or sequential doses of ALVAC-HIV vCP205 and SF2 rgp120 or control vaccines (ALVAC-RG rabies glycoprotein vCP65 or BIOCINE Placebo Vaccine 2). In each group, 21 volunteers receive vaccine and 4 receive control vaccines. Volunteers are stratified by lower or higher risk sexual behavior. Immunizations are given to three groups at months 0, 1, 3, 6, 9, and 12, and to the other three groups at months 0, 1, 6, 9, and 12. Volunteers are followed for 24 months.
研究の種類
入学
段階
- フェーズ 1
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- UAB AVEG
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Maryland
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Baltimore、Maryland、アメリカ
- JHU AVEG
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Missouri
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Saint Louis、Missouri、アメリカ、63104
- St. Louis Univ. School of Medicine AVEG
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New York
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Rochester、New York、アメリカ、14642
- Univ. of Rochester AVEG
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Tennessee
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Nashville、Tennessee、アメリカ、37232
- Vanderbilt Univ. Hosp. AVEG
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Washington
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Seattle、Washington、アメリカ、98144
- UW - Seattle AVEG
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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
Volunteers must have:
- Normal history and physical exam.
- Negative ELISA and Western blot for HIV.
- CD4 count >= 400 cells/mm3.
- Normal urine dipstick with esterase and nitrite.
NOTE:
- No more than 10 percent of volunteers in each stratum may be over age 50.
Risk Behavior:
Allowed for volunteers stratified to the higher risk stratum:
High risk behavior for HIV infection, such as
- injection drug use within the past 12 months.
- higher or intermediate risk sexual behavior.
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
- Positive hepatitis B surface antigen.
- Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
- Occupational responsibilities that preclude compliance.
- Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
- Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
- Allergy to egg products or neomycin.
- Occupational exposure to birds.
Subjects with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- Prior immunization against rabies.
- History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
- Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
- History of cancer unless there has been surgical excision that is considered to have achieved cure.
Prior Medication:
Excluded:
- Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
- Experimental agents within 30 days prior to study entry.
- Prior HIV vaccines.
- Prior rabies immunization.
Prior Treatment:
Excluded:
- Blood products or immunoglobulin within the past 6 months.
For volunteers stratified to the lower risk stratum:
High risk behavior for HIV infection, such as
- injection drug use within the past 12 months.
- higher or intermediate risk sexual behavior.
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
- マスキング:ダブル
協力者と研究者
出版物と役立つリンク
一般刊行物
- Evans T, Corey L, Clements-Mann ML, Weinhold K, Belshe RB, Excler JL, Duliege AM. CD8+ CTL induced in AIDS vaccine evaluation group phase I trials using canarypox vectors (ALVAC) encoding multiple HIV gene products (vCP125, vCP205, vCP300) given with or without subunit boost. Int Conf AIDS. 1998;12:277 (abstract no 495/21192)
- Kaslow RA, Rivers C, Goepfert P, Tang J, El Habib R, Weinhold K, Mulligan MJ. Association of HLA class I alleles with cytotoxic T-lymphocyte (CTL) responses to gag and env in recipients of ALVAC-HIV canarypox vaccines. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 818]
- Bender TJ, Tang J, Rivers C, Mulligan MJ, Kaslow RA. Grouping by HLA class I supertype does not enhance HLA associations with CTL responses to ALVAC-HIV canarypox vaccine components. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 193)
- Corey L, Weinhold K, Montefiori D, McElrath J, Excler JL, Duliege AM, Stablein D. Combination candidate HIV vaccines using a canarypox vector (vCP205) followed by boosting with gp120(SF-2). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:209 (abstract no LB18)
- Corey L, Weinhold K, Montefiori D, Stablein D. CTL and neutralizing antibody responses with a combination HIV-1 vaccine regimen. Int Conf AIDS. 1998;12:636 (abstract no 33221)
- AIDS Vaccine Evaluation Group 022 Protocol Team. Cellular and humoral immune responses to a canarypox vaccine containing human immunodeficiency virus type 1 Env, Gag, and Pro in combination with rgp120. J Infect Dis. 2001 Feb 15;183(4):563-70. doi: 10.1086/318523. Epub 2001 Jan 18.
- Gupta K, Hudgens M, Corey L, McElrath MJ, Weinhold K, Montefiori DC, Gorse GJ, Frey SE, Keefer MC, Evans TG, Dolin R, Schwartz DH, Harro C, Graham B, Spearman PW, Mulligan M, Goepfert P; AIDS Vaccine Evaluation Group. Safety and immunogenicity of a high-titered canarypox vaccine in combination with rgp120 in a diverse population of HIV-1-uninfected adults: AIDS Vaccine Evaluation Group Protocol 022A. J Acquir Immune Defic Syndr. 2002 Mar 1;29(3):254-61. doi: 10.1097/00126334-200203010-00005.
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
- AVEG 022A
- 10573 (レジストリ識別子:DAIDS ES Registry Number)
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。
HIV感染症の臨床試験
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public Health募集HIV | HIV検査 | HIV とケアの関係 | HIV治療アメリカ
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
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University of Minnesota引きこもったHIV感染症 | HIV/エイズ | HIV | AIDS | エイズ・HIV問題 | エイズと感染症アメリカ
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton と他の協力者募集
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur... と他の協力者わからないHIV | HIVに感染していない子供たち | HIVにさらされた子供たちカメルーン
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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
-
Hospital Clinic of Barcelona完了
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Helios SaludViiV Healthcareわからない
ALVAC-HIV MN120TMG (vCP205)の臨床試験
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Walter Reed Army Institute of Research (WRAIR)わからない
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National Institute of Allergy and Infectious Diseases...完了
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Walter Reed Army Institute of Research (WRAIR)完了
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National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)完了
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National Institute of Allergy and Infectious Diseases...完了
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National Institute of Allergy and Infectious Diseases...完了
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National Institute of Allergy and Infectious Diseases...完了
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National Institute of Allergy and Infectious Diseases...完了
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National Institute of Allergy and Infectious Diseases...MRC/UVRI and LSHTM Uganda Research Unit; Fogarty International Center of the National Institute... と他の協力者完了
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National Institute of Allergy and Infectious Diseases...完了