A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321
A Phase I, Single-Blind Study to Determine the Safety, Tolerability and Pharmacodynamic Profiles of a Hepatitis B Antigen Combined With IMP321 Versus the Hepatitis B Antigen Alone and a Reference Vaccine in Healthy Young Male Volunteers
調査の概要
状態
条件
詳細な説明
In each cohort, 8 subjects will receive the hepatitis B antigen (10 µg) with IMP321 at one dose, 2 subjects will receive the reference hepatitis B antigen (10 µg) alone with physiological saline and 2 subjects will receive the commercial vaccine Engerix B® (20 µg).
Engerix B® will be administered intramuscularly. The other treatments will be administered subcutaneously.
The four successive cohorts of volunteers will be:
Cohort A:
- 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (3 µg),
- 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline,
- 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).
If the tolerability of this cohort is acceptable, the following cohort will be done.
Cohort B:
- 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (10 µg),
- 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with Physiological saline,
- 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).
If the tolerability of this cohort is acceptable, the following cohort will be done.
Cohort C:
- 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (30 µg),
- 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline,
- 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).
If the tolerability of this cohort is acceptable, the following cohort will be done.
Cohort D:
- 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (100 µg),
- 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline
- 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).
Blood samples will be collected on the morning of days 1, 29, 36, 57 and 85 for pharmacodynamic evaluation.
Monitoring for the occurrence of adverse events (AE), changes in physical examination, vital signs (blood pressure, pulse rate, respiration), electrocardiograms (ECG) and clinical laboratory tests (biochemistry, haematology, urinalysis) will be performed before and after each dose of the study drug to assess safety and tolerability.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Paris、フランス、75015
- SGS Aster-Cephac
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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:
- able to give a written informed consent ;
- healthy male volunteers aged between 18 and 40 years and post-menopausal healthy women aged between 18 and 55 years;
- with body mass index (weight/height²) in the range 18 to 30 kg/m²;
- registered with the French Social Security in agreement with the French Law (Huriet Law : N° 88.1138 - 20.12.88) on biomedical experimentation;
- able to comply with protocol requirements, including overnight stays, blood and urine sample collections as defined in the protocol;
- not previously vaccinated for Hepatitis B.
Exclusion Criteria:
- who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, HBV and HCV infection ;
- with any clinically significant abnormality following review of pre-study laboratory tests and full physical examination ;
- who have received any experimental drug within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health ;
- who forfeit their freedom by administrative or legal award or who were under guardianship ;
- unwilling to give their informed consent ;
- who present a positive laboratory test for Hepatitis B surface antigen (HbsAg), HBc antibodies, HIV 1 and 2 antibodies and HCV antibodies ;
- who have a history of allergy or intolerance to the study drug ;
- who had a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug ;
- who are known or suspected alcohol or drug abusers ;
- who present a positive laboratory test for urine drug screening (opiates, barbiturates, amphetamine, cannabis) ;
- who undergo surgery or have donated blood within 1 month prior to the start of the study ;
- who have taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 1 week prior to the first dose administration ;
- who receive any drug known to affect hepatic metabolism like cimetidine, ketoconazole, fluconazole, itraconazole, phenytoin, rifampicin, rifabutin within 1 month prior to the first dose administration ;
- who receive any drug known to affect renal tubular secretion like probenecid, beta-lactam antibiotics within 2 weeks prior to the first dose administration ;
- who present any clinical condition or prior therapy which, in the opinion of the investigator, made the subject unsuitable for the study.
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:基礎科学
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:あ
IMP321
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hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321
他の名前:
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プラセボコンパレーター:B
Saline
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hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline
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アクティブコンパレータ:C
Engerix B
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20 µg hepatitis B antigen absorbed on alum
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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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To evaluate clinical and laboratory safety and tolerability profiles
時間枠:3 months
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3 months
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二次結果の測定
結果測定 |
時間枠 |
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To determine T cell response induction efficacy
時間枠:3 months
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3 months
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協力者と研究者
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
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