Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
A Phase 1, Randomized, Observer-blind, Dose-escalating Study in Adult End-stage Renal Failure Patients to Explore the Safety, Tolerability, Pharmacokinetics and Immune Response to Recombinant Hepatitis B Virus Surface Antigen (rHBsAg) Co-administered With Dynavax Immunostimulatory Phosphorothioate Oligodeoxyribonucleotide (1018 ISS)
調査の概要
状態
条件
詳細な説明
Infection with hepatitis B virus (HBV) is a major global health problem. Worldwide, it is estimated that 2 billion people have been infected previously and 350 million are chronically infected. About 25% of people who do not initially clear the infection will later develop chronic active hepatitis. Hemodialysis and pre-dialysis patients with kidney failure have multiple immune defects that make them more likely to develop a chronic infection. In addition, hemodialysis increases the risk of exposure to HBV. Existing HBV vaccines are effective in preventing infection in healthy adults. However, poor responses occur in people who are over 40 years of age and have end-stage kidney failure.
This study will evaluate the safety, tolerability and immune response of three escalating dose levels of HEPLISAV™, compared with a commercially available HBV vaccine, Engerix-B®, in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease and are expected to eventually go on hemodialysis. About 72 patients will be included in the study. Once patients have been consented, screened, and randomized to treatment, they will receive four injections over a 24-week period, with follow-up visits at 28 and 50 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: Patients will receive treatment with one of three escalating dose levels of HEPLISAV™ or the comparator vaccine, Engerix-B®.
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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California
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Costa Mesa、California、アメリカ、92626
- West Coast Clinical Trials
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Minnesota
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Brooklyn Center、Minnesota、アメリカ、55430
- Twin Cities Clinical Research
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Texas
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Austin、Texas、アメリカ、78727
- Covance
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Virginia
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Charlottesville、Virginia、アメリカ、22908
- University of Virginia Health System, Nephrology Clinical Research Center
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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:
- Willing and able to give written informed consent
- Progressive loss of kidney function with more advanced stage 3 (GFR at least 45 mL/min) or stage 4 chronic kidney disease by National Kidney Foundation classification, and are expected to eventually go on hemodialysis
- Body mass index of 31 or less
Exclusion Criteria:
- Received previous vaccination with any HBV vaccine (1 or more doses)
- Any history of HBV infection
- Pregnant or breast-feeding, or planning a pregnancy during the study
- Has autoimmune disease
- Diagnosis of chronic kidney failure due to autoimmune disease
- Receiving hemodialysis treatment at the time of enrollment
- Received any blood products or antibodies within 3 months prior to study entry, or is likely to require blood products during the study
- Ever received an injection with DNA plasmids or oligonucleotides
- Received erythropoietin within 7 days prior to the first study injection
- Received vaccination with any vaccines during the 4 weeks prior to study entry
- Received any other investigational medicinal agent during the 4 weeks 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：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 |
|---|---|
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実験的：1
低用量
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Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
他の名前：
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アクティブコンパレータ：4
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IM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24
他の名前：
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実験的：2
中用量
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Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
他の名前：
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実験的：3
高用量
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Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
他の名前：
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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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有害事象の発生と局所および全身の反応率
時間枠：28週間
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28週間
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Portion of subjects who have a seroprotective immune response (anti-HBsAg antibody ≥ 10 mIU/mL)
時間枠：28 days
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28 days
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協力者と研究者
捜査官
- スタディディレクター：Eduardo Martins, MD, DPhil、Dynavax Technologies Corporation
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 (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
- DV2-HBV-09
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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。