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Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector

2019年7月16日 更新者：Takeda

Phase 1b, Partial-Blind, Parallel Group, Randomized Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine (DENVax) Administered Intradermally Using Needle or a Needle-Free PharmaJet® Injector in Healthy Adults

The purpose of this study is to compare the safety, tolerability and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered intradermally in varied dosing schedules and via different methods of administration (conventional needle/syringe versus needle-free PharmaJet® injector).

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is an exploratory trial to assess the safety, tolerability and immunogenicity of vaccination with a tetravalent dengue vaccine (TDV) in healthy adults delivered intradermally using the conventional needle/syringe or a needle-free PharmaJet® injector.

Two (2) intradermal injections of either vaccine or placebo will be administered to qualified participants (one in each arm) on Day 0 of the study. A subsequent injection will also be given on Day 90 with either vaccine or placebo (in one arm only).

Participants will be evaluated for safety and dengue neutralizing antibody to all four serotypes. All participants will also be evaluated for injection site reactions and have blood drawn for viremia, neutralizing antibodies, cell mediated immunity and innate immunity.

Participants will be required to participate for approximately 10 months from recruitment and collection of data for primary outcomes (through Day 120) including collection of additional samples for measurement of longer term antibody titers (through Day 270).

This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201000034C.

研究の種類

介入

入学 (実際)

67

段階

  • フェーズ 1

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

  • アメリカ
    • Texas
      • Galveston、Texas、アメリカ、77555
        • University of Texas Medical Branch
    • Washington
      • Seattle、Washington、アメリカ、98101
        • Group Health Research Institute

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～45年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • In good health as determined by medical history and physical examination (including blood pressure and heart rate).
  • Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies & Hepatitis B surface antigen.
  • Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception.
  • Body Mass Index (BMI) ≤ 35 kg/m^2.

Exclusion Criteria:

  • Any Grade 2 or above abnormality in the screening laboratory tests.
  • History of Dengue Fever, Japanese Encephalitis, West Nile or Yellow Fever disease.
  • Seropositivity to dengue or West Nile virus.
  • Extensive scarring or tattoo (> 50%) on arms, shoulders, neck face and head.
  • History of significant dermatologic disease in the last 6 months.
  • Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the Day 0 or 90 vaccinations.
  • Any planned travel to dengue endemic areas including the Caribbean, Mexico, Central America, South America or Southeast Asia, during the study period and during the month prior to screening.
  • Use of systemic corticosteroids therapy within the previous 6 months (at a dose of 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or used within the last month prior to the first vaccination.
  • Use of any prescribed medication 7 days before the first injection.
  • Previous vaccination in a clinical study or with an approved product against Dengue Fever, Yellow Fever and or Japanese Encephalitis.
  • Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy in the last 6 months.
  • Planned donation of blood during the period of the study.

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：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Group 1: TDV using PharmaJet® Injector
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
生物学的：TDV
TDV suspension for intradermal administration
薬：Placebo
Phosphate buffered saline (PBS)
実験的：Group 2: TDV using PharmaJet® Injector
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
生物学的：TDV
TDV suspension for intradermal administration
薬：Placebo
Phosphate buffered saline (PBS)
実験的：Group 3: TDV using Needle and Syringe
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
生物学的：TDV
TDV suspension for intradermal administration
薬：Placebo
Phosphate buffered saline (PBS)
実験的：Group 4: TDV using PharmaJet® Injector
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
生物学的：TDV
TDV suspension for intradermal administration

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
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
時間枠：28 Days after each dose
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
28 Days after each dose
Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity
時間枠：28 Days after each dose
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant's worst reported severity grade.
28 Days after each dose
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
時間枠：14 days after each dose
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
14 days after each dose
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
時間枠：14 days after each dose
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade.
14 days after each dose
Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity
時間枠：28 Days after each dose
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
28 Days after each dose
Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)
時間枠：118 Days

The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs.

Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention.
118 Days
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection
時間枠：Day 28
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Day 28
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection
時間枠：Day 118
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Day 118
Percentage of Participants With Unsolicited Vaccine-Related SAEs
時間枠：Dose 1 until 28 days after Dose 2 (Up to Day 118)
A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes.
Dose 1 until 28 days after Dose 2 (Up to Day 118)

二次結果の測定

結果測定
メジャーの説明
時間枠
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
時間枠：Days 0, 28, 90, 118 and 270
Days 0, 28, 90, 118 and 270
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
時間枠：Days 90 and 270
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Days 90 and 270
Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination
時間枠：Day 0 to Day 104
A quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay was used for detection and serotype identification of dengue viral ribonucleic acid (RNA) that is present in serum. A test for viremia is considered positive if the assay value is >= 3.6, which is the limit of quantification (LOQ), negative if the assay value was zero, and undetermined if the assay value is >0 but <3.6. The percentage of participants with positive results is reported.
Day 0 to Day 104

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

Takeda

協力者

National Institutes of Health (NIH)

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

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 (実際)

2013年2月15日

一次修了 (実際)

2014年6月26日

研究の完了 (実際)

2014年6月26日

試験登録日

最初に提出

2012年12月17日

QC基準を満たした最初の提出物

2013年1月8日

最初の投稿 (見積もり)

2013年1月10日

学習記録の更新

投稿された最後の更新 (実際)

2019年7月18日

QC基準を満たした最後の更新が送信されました

2019年7月16日

最終確認日

2019年7月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 11-0049
  • U1111-1178-6503 (レジストリ識別子：WHO)

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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