Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects
2014年12月2日 更新者：Novartis Vaccines
A Phase III, Multicenter, Observer-blind, Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Concomitantly and/or Separately According to 1 of 2 Different Preexposure Prophylaxis Schedules to Healthy Adult Subjects.
Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis.
調査の概要
研究の種類
介入
入学 (実際)
661
段階
- フェーズ 3
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
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Vienna
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Kinderspitalgasse 15、Vienna、オーストリア、A-1090
- Institute of Specific Prophylaxis and Tropical Medicine Center for Pathophysiology, Infectious Diseases and Immunology Medical University of Vienna
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Zürich
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Rämistrasse 71、Zürich、スイス、CH-8006
- The University of Zurich
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Hamburg
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Bernhard-Nocht-Strasse 74、Hamburg、ドイツ、D-20359
- Bernhard Nocht Institute for Tropical Medicine
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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
18年～65年 (大人、高齢者)
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:
- Males and females between 18 and 65 years of age (inclusive).
- Subjects who have given written consent.
- Individuals in good health as per investigator judgement.
Exclusion Criteria:
- If female, pregnancy or unwillingness to practice acceptable contraception.
- If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test.
- Contraindication or precaution against Rabies and Japanese Encephalitis vaccination.
- Unable to comprehend and to follow all required study procedures for the whole period of the study.
- Participating in any other clinical trial 30 days prior to first study visit.
- History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis immunization.
- Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43.
- Received any other vaccines within 2 weeks prior to enrollment in this study or plan to receive any vaccine within 4 weeks from the study vaccines.
- Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
- Individuals who are part of study personnel or close family members conducting this study.
- Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study vaccination.
- Plans to travel within the next year to areas where Rabies and/or Japanese Encephalitis vaccine may be considered or offered. This includes but is not limited to India, Asia, Pacific-Rim, African countries.
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：R/JE - Conv
Subjects received Rabies and Japanese Encephalitis (JE) vaccines following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
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Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
Subjects received two doses of Japanese Encephalitis vaccine.
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
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実験的：R/JE - Acc
Subjects received Rabies and JE vaccines following the accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
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Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
Subjects received two doses of Japanese Encephalitis vaccine.
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
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アクティブコンパレータ：R - Conv
Subjects received Rabies vaccine following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
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Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
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アクティブコンパレータ：JE - Conv
Subjects received JE vaccine following the conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
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Subjects received two doses of Japanese Encephalitis vaccine.
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
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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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Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination
時間枠：Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)
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Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv. |
Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)
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Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination
時間枠：Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)
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Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv. |
Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)
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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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RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination
時間枠：Day 57 (28 days after last active vaccination)
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Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule. Data were adjusted using ANOVA model, as per protocol specification. |
Day 57 (28 days after last active vaccination)
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PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination
時間枠：Day 57 (28 days after last active vaccination)
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Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule. Data were adjusted using ANOVA model, as per protocol specifications. |
Day 57 (28 days after last active vaccination)
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Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination
時間枠：Day 36 and day 57 (28 days after last active vaccination)
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Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule. As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv. |
Day 36 and day 57 (28 days after last active vaccination)
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Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination
時間枠：Day 15 and day 36 (28 after last active vaccination)
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Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule. As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv. |
Day 15 and day 36 (28 after last active vaccination)
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Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL
時間枠：Day 1, 8, 15, 36, 57, 91, 181 and Day 366
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To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.
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Day 1, 8, 15, 36, 57, 91, 181 and Day 366
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Kinetics of Rabies Immune Response Measured as the RVNA GMCs
時間枠：Day 1, 8, 15, 36, 57, 91, 181, and 366
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To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.
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Day 1, 8, 15, 36, 57, 91, 181, and 366
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Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10
時間枠：Days 1, 15, 22, 36, 57, 91, 181 and 366
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To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).
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Days 1, 15, 22, 36, 57, 91, 181 and 366
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Kinetics of JE Immune Response Measured as PRNT50 GMTs
時間枠：Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)
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To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).
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Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)
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Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination
時間枠：Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)
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Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE - Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE - Conv and R - Conv groups).
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Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)
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Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination
時間枠：Day 1 through day 7 after each vaccination (on day 1, 8 and 29)
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Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE - Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE - Con and JE - Conv groups).
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Day 1 through day 7 after each vaccination (on day 1, 8 and 29)
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Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection
時間枠：Day 1 through day 7 after each injection (day 1, 4, 8 and 29)
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Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R - Conv and JE - Conv groups), day 4 through day 10 (injection on day 4; in R/JE - Conv, R - Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE - Conv, R - Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE - Acc, R - Con and JE - Conv groups).
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Day 1 through day 7 after each injection (day 1, 4, 8 and 29)
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Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination
時間枠：Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)
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Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.
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Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)
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Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57
時間枠：Day 1 through Day 57
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Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.
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Day 1 through Day 57
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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。
一般刊行物
- Cramer JP, Jelinek T, Paulke-Korinek M, Reisinger EC, Dieckmann S, Alberer M, Buhler S, Bosse D, Meyer S, Fragapane E, Costantini M, Pellegrini M, Lattanzi M, Dovali C. One-year immunogenicity kinetics and safety of a purified chick embryo cell rabies vaccine and an inactivated Vero cell-derived Japanese encephalitis vaccine administered concomitantly according to a new, 1-week, accelerated primary series. J Travel Med. 2016 Mar 19;23(3):taw011. doi: 10.1093/jtm/taw011. Print 2016 Mar.
- Jelinek T, Cramer JP, Dieckmann S, Hatz C, Paulke-Korinek M, Alberer M, Reisinger EC, Costantini M, Gniel D, Bosse D, Lattanzi M. Evaluation of rabies immunogenicity and tolerability following a purified chick embryo cell rabies vaccine administered concomitantly with a Japanese encephalitis vaccine. Travel Med Infect Dis. 2015 May-Jun;13(3):241-50. doi: 10.1016/j.tmaid.2015.05.008. Epub 2015 May 18.
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
2012年8月1日
一次修了 (実際)
2012年12月1日
研究の完了 (実際)
2013年10月1日
試験登録日
最初に提出
2012年8月2日
QC基準を満たした最初の提出物
2012年8月7日
最初の投稿 (見積もり)
2012年8月10日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年12月8日
QC基準を満たした最後の更新が送信されました
2014年12月2日
最終確認日
2014年12月1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
- V49_23
- 2011-005173-23 (EudraCT番号)
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。