Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults
Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults vs. Healthy Adolescents and Young Adults: Non-randomized Controlled Clinical Trial
調査の概要
状態
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Milan、イタリア、20157
- 募集
- Luigi Sacco Hospital , Department of Paediatrics, via G.B Grassi, 74
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コンタクト：
- Francesca Penagini, Doctor
- 電話番号：0039/02/39042234
- メール：frapenagini@tiscali.it
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副調査官：
- Alessandra Viganò, Paediatrician
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副調査官：
- Francesca Di Nello, Doctor
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副調査官：
- Vania Giacomet, Paediatrician
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主任研究者：
- Gian Vincenzo Zuccotti, Full Professor
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副調査官：
- Paola Erba, Paediatrician
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副調査官：
- Valeria Manfredini, Doctor
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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:
For both HIV-infected and healthy subjects:
- Subjects aged 13-27 years, females and males
- Written informed consent from parent or guardian if applicable (age<18 years)
For HIV-infected subjects:
- HIV-positive
- Asymptomatic subjects (generalized lymphadenopathy is accepted)
- Lymphocyte CD4+ count > or equal to 350 cells/mm3
For subjects receiving HAART:
- Good compliance to therapy
- At least two suppressed viral loads HIV-RNA (<37copies/ml9 during 6 months prior to enrollment.
Exclusion Criteria:
- For female subjects (both HIV-infected and healthy)
- Pregnancy or breastfeeding
- Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded.
- For both females and males (HIV-infected and healthy):
- Prior vaccination with quadrivalent HPV vaccine Gardasil before study entry.
- History of severe allergic reaction after previous vaccination or hypersensitivity to any vaccine component.
- Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator:
- Acute infection requiring therapy or fever at time of enrollment
- Chronic autoimmune or oncologic disease receiving chemotherapy
- Concomitant therapies (other than HAART):
- Chronic therapy (for more than 14 days consecutively) with immunosuppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry.
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry.
- Use of investigational agents within 4 weeks prior to study enrollment.
- Current drug or alcohol use or dependence.
- Documented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：HIV-infected adolescents and young adults
female and male HIV-infected subjects aged from 13-27 years old
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Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed). Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule: First dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1. Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately: Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms. Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed). Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule: first dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1. Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately: Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms. |
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アクティブコンパレータ：healthy adolescents and young adults
female and male healthy adolescents and young adults aged 13-27 years
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Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed). Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule: First dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1. Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately: Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms. Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed). Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule: first dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1. Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately: Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms. |
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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type specific antibody titers for HPV types 6, 11, 16 and 18 at one month after completion of HPV vaccine series (T3) in HIV infected subjects vs. healthy subjects
時間枠：one month +/- 10 days after 3° vaccine dose
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Immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) will be assessed by evaluation of type-specific antibody development for HPV types 6, 11, 16 and 18 from seronegative status at baseline (T0) to seropositive status at one month after the completion of HPV vaccine series (T3), compared with the same immunogenicity testings performed in healthy subjects matched for sex and age.
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one month +/- 10 days after 3° vaccine dose
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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antibody HPV titers to types 6, 11, 16 and 18, one month after the first two vaccination series (T1 and T2) in HIV-infected subjects vs healthy subjects
時間枠：one month +/- 10 days after 1°vaccine dose and month+/- 10 days after 2° vaccine dose
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Antibody titers for HPV types 6, 11, 16 and 18 will be evaluated one month after the first (T1) and second (T2) vaccination dose in HIV-infected adolescents and young adults compared with the same immunological testings in healthy adolescents and young adults.
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one month +/- 10 days after 1°vaccine dose and month+/- 10 days after 2° vaccine dose
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antibody titers to HPV types 6, 11, 16 and 18 at month 12(T4)and 18 (T5)from baseline (T0).
時間枠：12 months +/- 10 days and 18 months +/-10 days from baseline
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To assess long-term immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil® in HIV-infected and healthy subjects by evaluation of persistence of HPV antibody titers to types 6, 11, 16 and 18 at month 12 (T4) and 18(T5) from baseline (T0).
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12 months +/- 10 days and 18 months +/-10 days from baseline
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local and systemic adverse events
時間枠：7 days after each vaccination dose
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Safety and tolerability of three doses of quadrivalent human papillomavirus vaccine (Gardasil ®) in HIV-infected and healthy subjects will be assessed by evaluating the occurrence and severity of local and systemic adverse events during the 7 days after each vaccination dose.
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7 days after each vaccination dose
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HIV viral load and lymphocyte CD4+ count
時間枠：baseline (T0), one month after each vaccination dose (T1, T2 and T3) and at month 12 (T4) and 18 (T5) from baseline.
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Longitudinal monitoring of HIV-viral load and lymphocyte CD4+ count will be conducted in HIV-infected subjects from baseline (T0), throughout the study: one month after each vaccination dose (T1, T2, T3) and at month 12 and 18 from baseline (T4, T5).
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baseline (T0), one month after each vaccination dose (T1, T2 and T3) and at month 12 (T4) and 18 (T5) from baseline.
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lymphoproliferative responses, cytokine production and immunophenotype analysis of lymphocyte subpopulations
時間枠：baseline (T0), one month after 1° vaccination dose (T1) and one month after 3° vaccination dose (T3).
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To evaluate in a subgroup of subjects (20 HIV-infected and 20 healthy) the following immunological parameters at baseline and at 1 month after 1° vaccination dose (T1) and at 1 month after 3° vaccination dose (T3): lymphoproliferative responses to HPV-16 L1 from PBMCs in peripheral blood Immunophenotype analysis of lymphocyte subpopulations in peripheral blood Cytokine production from peripheral lymphocyte subpopulations at baseline and after stimulation with HPV-16 recombinant protein L1. |
baseline (T0), one month after 1° vaccination dose (T1) and one month after 3° vaccination dose (T3).
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Gian Vincenzo Zuccotti, Head of Paediatric Department、L.Sacco Hospital, via G.B Grassi, 74 20157 Milano, Italy
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
その他の研究ID番号
- HLS04/2011
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