SrRNAベースの帯状疱疹ワクチンJCXH-105を評価する第2相試験
50歳以上の健康な被験者を対象とした治験用帯状疱疹（HZ）ワクチンJCXH-105の安全性と免疫原性を評価する第2相無作為化三重盲検実薬対照試験
The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles).
Subjects will be randomized to receive either JCXH-105 or Shingrix.
調査の概要
詳細な説明
This Phase 2 study plans to enroll a total of 460 subjects.
This will be an active-controlled study in healthy male and/or female subjects 50 years of age or older. Subjects will be randomized 1:1 to receive either JCXH-105 or Shingrix. The study vaccine will be administered in two doses approximately 2 months apart. The subject will receive a single intramuscular (IM) injection of JCXH-105 or Shingrix on Day 1 (Dose 1) and again on Day 61 ± 7 days (Dose 2). For each subject, Dose 1 and Dose 2 are the same study vaccine based on randomization on Day 1. A total of 460 subjects will be enrolled into this trial and vaccinated with either JCXH-105 (n=230) or Shingrix (n=230).
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Arizona
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Tucson、Arizona、アメリカ、85704
- Noble Clinical Research
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California
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Long Beach、California、アメリカ、90805
- Long Beach Research Institute
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Illinois
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Chicago、Illinois、アメリカ、60652
- DM Clinical Research - Chicago
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Nebraska
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Omaha、Nebraska、アメリカ、68114
- Quality Clinical Research
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New Jersey
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Jersey City、New Jersey、アメリカ、07306
- DM Clinical Research - New Jersey
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South Carolina
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Charleston、South Carolina、アメリカ、29407
- Delricht Research
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Texas
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Prosper、Texas、アメリカ、75078
- Delricht Research
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Sugar Land、Texas、アメリカ、77478
- DM Clinical Research - Sugarland
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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
Key Inclusion Criteria:
- Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Age: ≥ 50 years of age at screening.
- Status: Healthy subjects.
- Subjects must agree to not be vaccinated with any HZ vaccine while participating in this study.
- Subjects must agree to not be vaccinated with any RNA-based vaccines (e.g., Spikevax, Comirnaty, etc.) 30 days before Dose 1 through 30 days after Dose 2 (a 4-month period).
Key Exclusion Criteria:
- Subjects with a history of HZ within the past 10 years or current diagnosis of HZ.
- Previous vaccination against HZ.
- Subjects with any respiratory illness deemed clinically relevant by the Investigator within the past month OR hospitalization >24 hours for any reason within the past month prior to the first vaccine administration (JCXH-105 or Shingrix).
- Subjects who are acutely ill or febrile with body temperature ≥ 38.0º Celsius/100.4º Fahrenheit 72 hours prior to or at the Screening visit or on Day 1 pre-dose. Subjects meeting this criterion may be rescheduled within an allowable window with approval from the Sponsor.
- Subjects with history or current diagnosis of congenital or acquired immunodeficiency/immunocompromising/immunosuppressive conditions, asplenia, or recurrent severe infections. Certain immune-mediated conditions (e.g., Hashimoto thyroiditis) that are well controlled and stable are allowed.
- Subjects with history of myocarditis or pericarditis, or with AEs (including anaphylaxis and severe hypersensitivity) after mRNA vaccination that are in nature and severity beyond the common expected AEs and necessitating medical intervention.
- Subjects who received any non-live vaccine within 14 days prior to Day 1 (first dose of JCXH-105 or Shingrix).
- Subjects who received within 28 days prior to Day 1 (first dose of JCXH-105 or Shingrix): (1) Any live vaccine, (2) Immunomodulators or immune-suppressive medication, (3) Granulocyte or granulocyte-macrophage colony-stimulating factor, (4) Three or more consecutive days of systemic corticosteroids. Note: subjects on stable-dose steroid replacement (for chronic disease such as iatrogenic deficiency) of prednisone ≤10 mg/day or equivalent are allowed and (5) Other investigational agents or devices.
- Subjects receiving systemic antiviral therapy.
- Subjects with a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, anti-human HIV-1 and 2 antibodies, or syphilis.
- Subjects with a positive screening test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
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：Investigational Product
Participants randomized to this arm will be given the investigational product (JCXH-105). |
IM injection |
|
アクティブコンパレータ：Active Control
Participants randomized to this arm will be given the FDA approved Shingrix. |
IM injection |
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 |
|---|---|---|
|
SAE Frequency
時間枠：Day 1 - Day 241 (Week 34)
|
Frequency of SAEs characterized by type, severity, duration, and relationship to the vaccine recorded from Day 1 post-vaccine administration through follow-up completion. |
Day 1 - Day 241 (Week 34)
|
|
Solicited local reaction frequency
時間枠：Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
|
Occurrence of solicited local injection site reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration. |
Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
|
|
Solicited systemic reaction frequency
時間枠：Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
|
Occurrence of solicited systemic reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration. |
Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
|
|
AE Frequency
時間枠：Day 1 - Day 241 (Week 34)
|
Adverse events (AEs) including unsolicited AEs and any AEs leading to discontinuation of study vaccine or withdrawal from the study, characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion. |
Day 1 - Day 241 (Week 34)
|
|
AESIs Frequency
時間枠：Day 1 - Day 241 (Week 34)
|
AESIs characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion. |
Day 1 - Day 241 (Week 34)
|
|
Medically Attended AE Frequency
時間枠：Day 1 - Day 241 (Week 34)
|
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion. |
Day 1 - Day 241 (Week 34)
|
|
Immune-Mediated Adverse Events of Special Interest Frequency
時間枠：Day 1 - Day 241 (Week 34)
|
Immune-mediated adverse events of special interest (imAESIs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration through follow-up completion. |
Day 1 - Day 241 (Week 34)
|
|
gE-Specific CD4+ T cell Response Rate
時間枠：Day 1 - Day 89 (Week 13)
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Response Rate is defined at the percentage of subjects with ≥ 2 folds increase of gE-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNFα, and CD40L) in PBMCs analyzed with flow cytometry with ICS on Day 89 as compared to baseline (Day 1 pre-dose). |
Day 1 - Day 89 (Week 13)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cellular immunogenicity of JCXH-105
時間枠：Day 1 - Day 241 (Week 34)
|
Frequency of glycoprotein E (gE)-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNF-α, and CD40L) in PBMCs analyzed by flow cytometry with ICS on Day 29, Day 89, and Day 241 as compared to baseline (Day 1 pre-dose). |
Day 1 - Day 241 (Week 34)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cellular Immunogenicity of JCXH-105
時間枠：Day 1 - Day 241 (Week 34)
|
Frequency of gE-specific CD8+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNF-α, and CD40L) in PBMCs analyzed by flow cytometry on Day 29, Day 89, and Day 241 as compared to baseline (Day 1 pre-dose). |
Day 1 - Day 241 (Week 34)
|
|
Humoral immunogenicity of JCXH-105
時間枠：Day 1 - Day 241 (Week 34)
|
Changes in serum of anti-gE-specific antibody geometric mean titers (GMTs) analyzed with enzyme-linked immunosorbent assay (ELISA) on Day 29, Day 89, and Day 241 as compared to baseline (D1 pre-dose). |
Day 1 - Day 241 (Week 34)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
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 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- JCXH-105-021
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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