Safety and Immunogenicity Study of tgAAC09, an HIV Vaccine in an Adeno-associated Virus (AAV) Capsid (TGC14F)
Phase II, Placebo-controlled, Double-blind, Dose-escalation/Dose-optimization Trial to Evaluate Safety and Immunogenicity of tgAAC09, an HIV Vaccine Containing Clade C Gag-PR-ΔRT DNA in an Adeno-associated Virus (AAV) Capsid
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
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 male or female
- Age at least 18 years on the day of screening and no greater than 50 years on the day of the first study injection
- Willing to comply with the requirements of the protocol and available for follow up for the planned duration of the study
- Able and willing to give informed consent.
- Willing to undergo HIV testing, counseling and receive results
- If sexually active female of child-bearing potential (not menopausal or anatomically sterile), willing to use an effective method of contraception (hormonal contraceptives; intrauterine contraceptive device (IUCD); condoms; anatomical sterility in self or partner) from screening until at least four months after last study injection and willing to undergo urine pregnancy tests at screening, prior to each injection and four months after the last injection
- If sexually active male, willing to use a method of contraception (such as condoms) from screening until four months after the last study injection
Exclusion Criteria:
- HIV-1 or HIV-2 infection
- Active tuberculosis
- Clinically relevant abnormality on history or examination including history of immunodeficiency, or cancer, or autoimmune disorder
- Use of systemic corticosteroids, immunosuppressive or anticancer medications in the last six months
- Chronic condition that, in the opinion of the investigator or the designated trial physician, would make the volunteer unsuitable for the study
Any of the following abnormal laboratory parameters:
- Hemoglobin <9.0 g/dL (females), <12.0 g/dL (males)
- Absolute Neutrophil Count (ANC): ≤ 999/mm3
- Absolute Lymphocyte Count (ALC): ≤ 500/mm3
- Platelets: decreased ≤ 90,000 or increased ≥ 550,000/mm3
- Creatinine: > 1.4 x ULN
- AST: >3.0 x ULN
- ALT: >3.0 x ULN
- Urine dipstick: blood = 2+ or more (except in menstruating females); protein = 2+ or more
Any of the following high-risk behaviors:
- Had unprotected vaginal or anal sex with a known HIV positive person in the past six months
- Had unprotected vaginal or anal sex with a casual partner (i.e. no continuing established relationship) in the past six months
- Engaged in sex work for money or drugs in the past six months
- Used injection drugs illegally in the past six months
- Acquired a sexually transmitted infection (STI) in the past six months
- If female, pregnant, lactating or planning a pregnancy within four months after last study injection
- Receipt of live attenuated vaccine within 30 days or other vaccine within 14 days of the first study injection
- Receipt of blood transfusion or blood products six months prior to the first study injection
- Participation in another clinical trial of an investigational product currently or within last 12 weeks of first study injection or expected participation during this study
- Prior receipt of an investigational HIV vaccine
- History of severe local or systemic reaction to vaccination(s) or history of severe allergic reactions
- History of major neurological or psychiatric disorders
- Positive for hepatitis B surface antigen, active untreated syphilis (confirmed by treponemal test such as TPHA in addition to nontreponemal test such as RPR) or other active sexually transmitted diseases
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:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Group A
Number of Vaccine Recipients: 10 Dosage level 3 x 10^10 DRP Month 0 + 6 |
|
実験的:Group B
Number of Vaccine Recipients: 10 Dosage level 3 x 10^10 DRP Month 0+12 |
|
実験的:Group C
Number of Vaccine Recipients: 10 Dosage level 3 x 10^11 DRP Month 0+6 |
|
実験的:Group D
Number of Vaccine Recipients: 10 Dosage level 3 x 10^11 DRP Month 0+12 |
|
実験的:Group E
Number of Vaccine Recipients: 10 Dosage level 3 x 10^12 DRP Month 0+6 |
|
実験的:Group F
Number of Vaccine Recipients: 10 Dosage level 3 x 10^12 DRP Month 0+12 |
|
実験的:Group G
Number of Vaccine Recipients: 10 Preselected for baseline AAV neutralization titers of <1/8 Dosage level 3 x 10^12 DRP Month 0+6 |
|
プラセボコンパレーター:Placebo
3 volunteers will receive placebo matched to each experimental group.
|
Sterile isotonic buffered salt solution
|
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 |
---|---|
Safety: proportion of volunteers with severe local and systemic reactions, proportion of volunteers with other SAEs (including laboratory abnormalities) related to study vaccine, number of volunteers with SAEs related to study vaccine
時間枠:18 months
|
18 months
|
Proportion of volunteers with HIV-1 specific T- cell responses quantified by γ-IFN ELISPOT and magnitude of the response, and proportion of volunteers with HIV-1 specific binding antibodies and magnitude of the response
時間枠:18 months
|
18 months
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Safety: high versus low or negative titres of neutralizing antibodies to AAV2 at the time of each vaccination
時間枠:18 months
|
18 months
|
Immunogenicity: proportion of volunteers with HIV-1 specific T- cell responses by γ-IFN CFC or other T-cell assays
時間枠:18 months
|
18 months
|
Immunogenicity endpoints in volunteers with high versus low or negative titres of neutralizing antibodies to AAV2 at the time of each vaccination
時間枠:18 months
|
18 months
|
Immunogenicity endpoints in volunteers with versus without four-fold or greater increase in titres of neutralizing antibodies to AAV2 after vaccination
時間枠:18 months
|
18 months
|
Immunogenicity endpoints after the second study injection, compared with the first study injection
時間枠:18 months
|
18 months
|
Immunogenicity endpoints after the second study injection following a twelve-month interval compared to a six-month interval
時間枠:18 months
|
18 months
|
Vaccine biodistribution: presence and persistence of vaccine in peripheral blood mononuclear cells (PBMC), saliva, nasal swabs, urine and semen or cervical/vaginal secretions
時間枠:18 months
|
18 months
|
協力者と研究者
捜査官
- スタディチェア:Eftyhia Vardas, MD、Perinatal HIV Research Unit (PHRU), Baragwanath
- 主任研究者:Linda-Gail Bekker, MD、Desmond Tutu HIV Centre Cape Town
- 主任研究者:Anwar Hoosen、Medical University of Southern Africa (Medunsa)
- 主任研究者:Elwyn Chomba, MD、Zambia-Emory HIV Research Project (ZEHRP), Lusaka
- 主任研究者:Pontiano Kaleebu, MD, PhD、MRC/UVRI and LSHTM Uganda Research Unit
出版物と役立つリンク
便利なリンク
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 (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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IAVI A002
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
tgAAC09の臨床試験
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International AIDS Vaccine InitiativeChildren's Hospital of Philadelphia; Nationwide Children's Hospital; Targeted Genetics Corporation完了