このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™

2018年7月18日 更新者:GlaxoSmithKline

An Open Multicentre, Multicountry Study to Evaluate Long-term Antibody Persistence and Immune Memory Between Years 11 and 15 After the Primary Study HAB-084 in Which Healthy Adolescents Were Vaccinated With Twinrix™ Adult Following a Two-dose Schedule or Twinrix™ Junior Following a Three-dose Schedule.

This study will evaluate the immune response against Hepatitis-A (HAV) and Hepatitis B surface (HBs) antigen in healthy subjects aged 12 to 15 years (at the time of primary vaccination), who received vaccination course with GSK Biologicals' Twinrix Adult and Twinrix Junior vaccine, approximately 10 years ago in the primary study. The subjects will be invited for blood sampling at 11, 12, 13, 14 and 15 years after primary vaccination to evaluate the persistence of immune response. For subjects detected with decreased immunity, the presence of immune memory against hepatitis A & B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine 6 to 12 months after the Year 15 follow-up time-point.

No new subjects will be recruited during this booster phase of the study.

調査の概要

研究の種類

介入

入学 (実際)

210

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Hradec Kralove、チェコ、500 03
        • GSK Investigational Site
      • Bruxelles、ベルギー、1200
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

12年~15年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female who received the complete primary vaccination course according to his/her group allocation in the primary study
  • Written informed consent obtained from the subject.

All subjects must satisfy the following criteria at entry into the challenge dose phase:

  • A male or female who received the complete primary vaccination course according to his/her group allocation in the primary study.
  • Subjects who participated in the long-term follow-up phase of the primary study and for whom the antibody concentrations were below specified value for anti-HAV antibodies and/ or for anti-HBs antibodies at the last available follow-up time-points.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the challenge dose phase of this study.
  • If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after the vaccination.

Exclusion Criteria:

The following criteria should be checked at each follow-up visit. If any apply at study entry, the subject must not be included at that long-term follow-up visit.

  • Use of any investigational or non-registered product (drug or vaccine) since the last blood sampling visit.
  • Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine since the primary vaccination course of the primary study.
  • History of hepatitis A or hepatitis B infection.
  • Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within 3 months prior to blood sampling.

The following criteria should be checked before the challenge dose phase. If any apply, the subject must not be included in the challenge dose phase:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days before the administration of the challenge dose or planned use during the study period outside the context of the study.
  • Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine between the primary vaccination course of the primary study and the challenge dose visit.
  • History of hepatitis A or hepatitis B infection.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Acute disease at the time of.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the challenge dose or planned administration before the final blood sampling point (one month after the challenge dose).
  • Pregnant or lactating female.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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: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
実験的:Twinrix Adult Group
Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration.
If a subject became seronegative for anti-HAV antibodies (< 15 mIU/mL) or if anti-HBs antibody concentrations decreased below 10 mIU/mL during the long-term follow-up, immune memory against the antigen was evaluated by administering a challenge dose of the appropriate antigen (vaccine) 6 to 12 months after the Year 15 follow-up time-point.
実験的:Twinrix Junior Group
Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration.
If a subject became seronegative for anti-HAV antibodies (< 15 mIU/mL) or if anti-HBs antibody concentrations decreased below 10 mIU/mL during the long-term follow-up, immune memory against the antigen was evaluated by administering a challenge dose of the appropriate antigen (vaccine) 6 to 12 months after the Year 15 follow-up time-point.

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
Anti-HAV Antibody Concentrations
時間枠:At Year 11, 12, 13, 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.
At Year 11, 12, 13, 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values
時間枠:At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084
Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by ChemiLuminescence ImmunoAssay (CLIA).
At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084
Anti-HBs Antibody Concentrations
時間枠:At Year 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084.

Antibodys concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.

Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by CLIA.

At Year 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084.
Anti-HBs Anamnestic Response.
時間枠:One month after the challenge dose.

Anamnestic response was defined as:

Anti-HBs antibody concentrations ≥ 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time-points.

At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time-points.

One month after the challenge dose.
Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value.
時間枠:At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084.
Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).
At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084.

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.
時間枠:Since the last long-term follow-up visit up to Year 11.
SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Since the last long-term follow-up visit up to Year 11.
Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.
時間枠:Since the last long-term follow-up visit up to Year 12.
SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Since the last long-term follow-up visit up to Year 12.
Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.
時間枠:Since the last long-term follow-up visit up to Year 13.
SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Since the last long-term follow-up visit up to Year 13.
Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.
時間枠:Since the last long-term follow-up visit up to Year 14.
SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Since the last long-term follow-up visit up to Year 14.
Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.
時間枠:Since the last long-term follow-up visit up to Year 15.
SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Since the last long-term follow-up visit up to Year 15.
Number of Subjects With Anti-hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-off Value.
時間枠:Before (PRE) the challenge dose

Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).

Note: Since none of the subjects were seronegative for anti-HAV antibody concentration at the pre-challenge time point, subjects received only the HBV vaccine as the challenge dose.

Before (PRE) the challenge dose
Anti-HAV Antibody Concentrations
時間枠:Before (PRE) the challenge dose
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.
Before (PRE) the challenge dose
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events.
時間枠:During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose
Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-off Values
時間枠:Before (PRE) and one month after (POST) the challenge dose
Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL
Before (PRE) and one month after (POST) the challenge dose
Anti-HBs Antibody Concentrations
時間枠:Before (PRE) and one month after (POST) the challenge dose
Antibody concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.
Before (PRE) and one month after (POST) the challenge dose
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
時間枠:During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (axillary temperature). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature > 39.5°C. Related = general symptoms which were assessed by the investigator as causally related to vaccination.
During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms.
時間枠:During the 31-day (Day 0 to 30) follow-up period after the challenge dose.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = AE that prevented normal activity. Related = AE assessed by the investigator as causally related to the study vaccination.
During the 31-day (Day 0 to 30) follow-up period after the challenge dose.
Number of Subjects With Serious Adverse Events (SAEs).
時間枠:One month after the administration of the challenge dose (Month 0 to Month 1)
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
One month after the administration of the challenge dose (Month 0 to Month 1)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年5月1日

一次修了 (実際)

2014年7月1日

研究の完了 (実際)

2014年7月1日

試験登録日

最初に提出

2009年4月2日

QC基準を満たした最初の提出物

2009年4月2日

最初の投稿 (見積もり)

2009年4月3日

学習記録の更新

投稿された最後の更新 (実際)

2018年8月20日

QC基準を満たした最後の更新が送信されました

2018年7月18日

最終確認日

2018年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 110699
  • 110700 (その他の識別子:GSK)
  • 110701 (その他の識別子:GSK)
  • 110702 (その他の識別子:GSK)
  • 110703 (その他の識別子:GSK)
  • 110704 (その他の識別子:GSK)

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?

はい

IPD プランの説明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

試験データ・資料

  1. 研究プロトコル
    情報識別子:110699
    情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
  2. 個人参加者データセット
    情報識別子:110699
    情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
  3. 臨床研究報告書
    情報識別子:110699
    情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
  4. データセット仕様
    情報識別子:110699
    情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
  5. インフォームド コンセント フォーム
    情報識別子:110699
    情報コメント:For additional information about this study please refer to the GSK Clinical Study Register

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。

B型肝炎の臨床試験

  • The General Hospital of Western Theater Command
    まだ募集していません
  • Lapo Alinari
    募集
    MYC、BCL2、および BCL6 再構成を伴う再発高悪性度 B 細胞性リンパ腫 | MYC、BCL2、および BCL6 再構成を伴う難治性高悪性度 B 細胞性リンパ腫 | MYCおよびBCL2またはBCL6再構成を伴う再発性高悪性度B細胞リンパ腫 | MYCおよびBCL2またはBCL6再構成を伴う難治性高悪性度B細胞リンパ腫 | 再発性びまん性大細胞型 B 細胞性リンパ腫活性化 B 細胞型 | 難治性びまん性大細胞型 B 細胞性リンパ腫活性化 B 細胞型 | びまん性大細胞型B細胞リンパ腫への形質転換型無痛性B細胞非ホジキンリンパ腫 | 再発性びまん性大細胞型 B 細胞リンパ腫 胚中心 B 細胞型 | 難治性びまん性大細胞型...
    アメリカ
  • Arkansas Children's Hospital Research Institute
    Columbia University
    募集
    B細胞性急性リンパ芽球性白血病 | B細胞性急性リンパ芽球性白血病 | B細胞小児急性リンパ芽球性白血病 | B細胞白血病 | B細胞性リンパ芽球性白血病/リンパ腫 | B細胞性急性リンパ芽球性白血病(B-ALL) | B細胞ALL | B細胞リンパ芽球性白血病
    アメリカ
  • Athenex, Inc.
    募集
    B細胞リンパ腫 | CLL/SLL | すべて、子供時代 | DLBCL - びまん性大細胞型 B 細胞性リンパ腫 | B細胞白血病 | NHL、再発、成人 | ALL、成体 B 細胞
    アメリカ
  • Nathan Denlinger
    Bristol-Myers Squibb
    募集
    B細胞非ホジキンリンパ腫再発性 | びまん性大細胞型 B 細胞リンパ腫 - 再発性 | 濾胞性リンパ腫-再発性 | 高悪性度B細胞リンパ腫再発性 | 原発性縦隔大細胞型 B 細胞リンパ腫 - 再発性 | 緩徐進行性B細胞非ホジキンリンパ腫からびまん性大細胞型B細胞リンパ腫への転移 - 再発性 | B細胞非ホジキンリンパ腫難治性 | 難治性びまん性大細胞型 B 細胞リンパ腫 | 濾胞性リンパ腫難治性 | 難治性高悪性度B細胞リンパ腫 | 原発性縦隔大細胞型B細胞リンパ腫-難治性 | 緩徐進行性B細胞非ホジキンリンパ腫から難治性びまん性大細胞型B細胞リンパ腫への変化
    アメリカ
  • Northwestern University
    National Cancer Institute (NCI)
    完了
    びまん性大細胞型B細胞リンパ腫 | びまん性大細胞型B細胞リンパ腫、特に特定されていない | 特に明記されていない高悪性度B細胞リンパ腫 | T細胞/組織球が豊富な大細胞型B細胞リンパ腫 | MYCおよびBCL2および/またはBCL6再構成を伴う高悪性度B細胞リンパ腫 | びまん性大細胞型B細胞リンパ腫活性化B細胞型 | びまん性大細胞型 B 細胞リンパ腫 胚中心 B 細胞型
    アメリカ
  • Curocell Inc.
    募集
    高悪性度B細胞リンパ腫 | びまん性大細胞型B細胞リンパ腫(DLBCL) | 原発性縦隔大細胞型B細胞リンパ腫(PMBCL) | 形質転換濾胞性リンパ腫(TFL) | 難治性大細胞型B細胞リンパ腫 | 再発大細胞型B細胞リンパ腫
    大韓民国
  • First Affiliated Hospital Xi'an Jiaotong University
    Eureka Therapeutics Inc.
    わからない
  • University of Washington
    Regeneron Pharmaceuticals
    募集
    再発びまん性大細胞型B細胞リンパ腫 | 難治性びまん性大細胞型B細胞リンパ腫 | 特に明記されていない再発性びまん性大細胞型B細胞性リンパ腫 | 他に特定されない難治性びまん性大細胞型B細胞性リンパ腫 | 再発高悪性度B細胞リンパ腫 | 難治性高悪性度B細胞リンパ腫 | 再発グレード3bの濾胞性リンパ腫 | 難治性グレード3b濾胞性リンパ腫 | 再発性形質転換無痛性B細胞非ホジキンリンパ腫からびまん性大細胞型B細胞リンパ腫へ | 難治性形質転換低痛性B細胞非ホジキンリンパ腫からびまん性大細胞型B細胞リンパ腫へ | 再発性の原発性縦隔大細胞型B細胞リンパ腫 | 難治性原発性縦隔大細胞型B細胞リンパ腫
    アメリカ
  • David Bond, MD
    Bristol-Myers Squibb
    積極的、募集していない
    びまん性大細胞型B細胞リンパ腫 | 侵攻性非ホジキンリンパ腫 | 無痛性非ホジキンリンパ腫 | アナーバー IV 期 B 細胞性非ホジキンリンパ腫 | 特に明記されていない高悪性度B細胞リンパ腫 | 形質転換非ホジキンリンパ腫 | アナーバー II 期 B 細胞性非ホジキンリンパ腫 | アナーバー III 期 B 細胞性非ホジキンリンパ腫 | MYCおよびBCL2および/またはBCL6再構成を伴う高悪性度B細胞リンパ腫 | アナーバー I 期原発性縦隔(胸腺)大細胞型 B 細胞性リンパ腫 | アナーバー病期 II 原発性縦隔 (胸腺) 大細胞型 B 細胞性リンパ腫 | アナーバー病期 III 原発性縦隔 (胸腺) 大細胞型 B 細胞性リンパ腫 およびその他の条件
    アメリカ

Blood samplingの臨床試験

購読する