Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
Double-blind Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Two Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 12 Month Schedule in Healthy Adult Volunteers
The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.
This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20.
No additional subjects will be recruited during this long-term follow-up.
調査の概要
詳細な説明
This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations.
If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Months 138, 150, 162, 174,186, 198, 210, 222, 234 and 246), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to extend the follow up until Year 20.
The study has 10 phases: 100571, 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, 110681.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Wilrijk、ベルギー、2610
- GSK Investigational Site
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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:
- Subjects who had received at least one dose of the study vaccine in the primary study
- Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.
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：なし
- 介入モデル：単一グループの割り当て
- 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：Havrix Group
Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
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2 doses at 12 months interval
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
時間枠：At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).
** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed.
Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234.
$ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory.
Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
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At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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Number of Seropositive Subjects Against Hepatitis A Virus
時間枠：At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL).
** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed.
Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234.
$ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory.
Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
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At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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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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Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
時間枠：Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination
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Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198. Please note that value 14.9 means <15. |
Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination
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Number of Subjects Reporting Solicited Local Symptoms
時間枠：During the 4-day (Days 0-3) follow-up period after additional vaccination
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Solicited local symptoms assessed include pain, redness and swelling.
Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.
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During the 4-day (Days 0-3) follow-up period after additional vaccination
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Number of Subjects Reporting Solicited General Symptoms
時間枠：During the 4-day (Days 0-3) follow-up period after additional vaccination
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Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198. |
During the 4-day (Days 0-3) follow-up period after additional vaccination
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Number of Subjects Reporting Unsolicited Adverse Events (AE)
時間枠：During the 30-day follow-up period after additional vaccination
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An AE is 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. 4 subjects received additional vaccination at Month 186 and 1 at Month 198. |
During the 30-day follow-up period after additional vaccination
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Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy
時間枠：At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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An 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
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At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
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Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination
時間枠：During the 30-day follow-up period after additional vaccination
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An 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. 4 subjects received additional vaccination at Month 186 and 1 at Month 198. |
During the 30-day follow-up period after additional vaccination
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Number of Subjects Reporting Pregnancies After Additional Vaccination
時間枠：At Months 186 and 198
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The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated.
4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
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At Months 186 and 198
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Van Herck K, Jacquet JM, Van Damme P. Antibody persistence and immune memory in healthy adults following vaccination with a two-dose inactivated hepatitis A vaccine: long-term follow-up at 15 years. J Med Virol. 2011 Nov;83(11):1885-91. doi: 10.1002/jmv.22200. Epub 2011 Aug 23.
- Van Herck K, Crasta PD, Messier M, Hardt K, Van Damme P. Seventeen-year antibody persistence in adults primed with two doses of an inactivated hepatitis A vaccine. Hum Vaccin Immunother. 2012 Mar;8(3):323-7. doi: 10.4161/hv.18617. Epub 2012 Feb 13.
- Agrawal A, Kolhapure S, Andani A, Ota MOC, Badur S, Karkada N, Mitra M. Long-Term Persistence of Antibody Response with Two Doses of Inactivated Hepatitis A Vaccine in Children. Infect Dis Ther. 2020 Dec;9(4):785-796. doi: 10.1007/s40121-020-00311-8. Epub 2020 Jul 24.
- Theeten H, Van Herck K, Van Der Meeren O, Crasta P, Van Damme P, Hens N. Long-term antibody persistence after vaccination with a 2-dose Havrix (inactivated hepatitis A vaccine): 20 years of observed data, and long-term model-based predictions. Vaccine. 2015 Oct 13;33(42):5723-5727. doi: 10.1016/j.vaccine.2015.07.008. Epub 2015 Jul 16.
- Hens N, Habteab Ghebretinsae A, Hardt K, Van Damme P, Van Herck K. Model based estimates of long-term persistence of inactivated hepatitis A vaccine-induced antibodies in adults. Vaccine. 2014 Mar 14;32(13):1507-13. doi: 10.1016/j.vaccine.2013.10.088. Epub 2014 Feb 7.
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
- 100571 (M138)
- 100572 (M150) (その他の識別子：GSK)
- 100573 (M162) (その他の識別子：GSK)
- 100574 (M174) (その他の識別子：GSK)
- 100575 (M186) (その他の識別子：GSK)
- 110677 (M198) (その他の識別子：GSK)
- 110678 (M210) (その他の識別子：GSK)
- 110679 (その他の識別子：GSK)
- 110680 (その他の識別子：GSK)
- 110681 (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?
IPD プランの説明
試験データ・資料
-
個人参加者データセット
情報識別子：100571 (M138)情報コメント：For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100571 are summarised with studies 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, and 110681 on the GSK Clinical Study
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インフォームド コンセント フォーム
情報識別子：100571 (M138)情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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研究プロトコル
情報識別子：100571 (M138)情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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データセット仕様
情報識別子：100571 (M138)情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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臨床研究報告書
情報識別子：100571 (M138)情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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統計分析計画
情報識別子：100571 (M138)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。
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