A Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
2019年2月18日 更新者:Janssen Vaccines & Prevention B.V.
A Randomized, Double-blind, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF,
administered intramuscularly to elderly adults given approximately 12 months apart.
調査の概要
研究の種類
介入
入学 (実際)
73
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
-
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Florida
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Miami、Florida、アメリカ
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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
60年歳以上 (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:
- Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
- Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; and not intending to conceive by any methods
- From the time of first vaccination until 3 months after the first dose of study vaccine, and from the second vaccination through 3 months after, a man who has not had a vasectomy (or if a vasectomy was performed less than 1 year ago and the absence of sperm cannot be verified)
- In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grades 1 or 2 according to the US Food and Drug Administration (FDA) toxicity tables (for tests in the FDA table ), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Exclusion Criteria:
- Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree celsius within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
- Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has had major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study
- Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
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:ダブル
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:Ad26.RSV.preF 5*10^10 vp (Day 1 and Day 365): Group 1
Participants will receive 5*10^10 viral particles (vp) Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
|
Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
他の名前:
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実験的:Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2
Participants will receive 5*10^10 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
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Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
他の名前:
Participants will receive placebo as formulation buffer.
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実験的:Ad26.RSV.preF 1*10^11 vp (Day 1 and Day 365): Group 3
Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
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Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
他の名前:
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実験的:Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4
Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
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Participants will receive placebo as formulation buffer.
Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
他の名前:
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実験的:Placebo (Day 1 and Day 365): Group 5
Participants will receive placebo at Day 1 and Day 365 (10 to 13 months after first vaccination).
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Participants will receive placebo as formulation buffer.
|
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 |
時間枠 |
|---|---|
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Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
時間枠:7 days after each vaccination (Day 1)
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7 days after each vaccination (Day 1)
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Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
時間枠:7 days after each vaccination (Day 365)
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7 days after each vaccination (Day 365)
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Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
時間枠:7 days after each vaccination (Day 1)
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7 days after each vaccination (Day 1)
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Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
時間枠:7 days after each vaccination (Day 365)
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7 days after each vaccination (Day 365)
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Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
時間枠:28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
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28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
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Number of Participants With Serious Adverse Events (SAEs) Throughout Study
時間枠:Up to 730 days
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Up to 730 days
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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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Respiratory Syncytial Virus (RSV) Neutralization A2
時間枠:Days 1, 29, 183, 365, 393, 547, 730
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Analysis of RSV A2 neutralizing titers of the vaccine-induced immune response will be assessed.
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Days 1, 29, 183, 365, 393, 547, 730
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RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay
時間枠:Days 1, 29, 183, 365, 393, 547, 730
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Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form.
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Days 1, 29, 183, 365, 393, 547, 730
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Intracellular Cytokine Staining
時間枠:Day 1, 29, 183, 365, 393, 547, 730
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The activation of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T-cell subsets and their cytokine expression patterns will be determined by flow cytometry after RSV protein peptide stimulation (including, but not limited to CD4/CD8, interleukin [IL-2], interferon gamma [IFN gamma], tumor necrosis factor alpha [TNF-alpha] and/or activation markers, memory, T-helper [cells] Th1/Th2 subtyping).
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Day 1, 29, 183, 365, 393, 547, 730
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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。
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)
2016年11月8日
一次修了 (実際)
2018年3月14日
研究の完了 (実際)
2019年1月29日
試験登録日
最初に提出
2016年9月22日
QC基準を満たした最初の提出物
2016年10月5日
最初の投稿 (見積もり)
2016年10月6日
学習記録の更新
投稿された最後の更新 (実際)
2019年2月19日
QC基準を満たした最後の更新が送信されました
2019年2月18日
最終確認日
2019年2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
- CR108214
- VAC18193RSV1003 (その他の識別子:Janssen Vaccines & Prevention B.V.)
医薬品およびデバイス情報、研究文書
米国FDA規制機器製品の研究
いいえ
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