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The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination (FLU1)

2018年12月11日 更新者：Mark Mulligan、Emory University
This is a prospective pilot study designed to suggest differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system data will be collected at standard time points. The duration of the study for each participant will be approximately 1 month.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a prospective pilot study in 20 males and non-pregnant females, 20 to 30 years old, inclusive, who are in good health and meet all eligibility criteria. The study is designed to evaluate differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly.

Participants will be sorted to either Arm A (Naïve) or Arm B (Experienced) based on their vaccination history. Those vaccinated no more than 2 out of the past 5 years will be in Arm A. Those vaccinated 3 or more out of the past 5 years will be in Arm B. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. The duration of the study for each participant will be approximately 1 month. Subjects will return for clinic visits on Days 3, 8, 15, and 29 during the month follow-up period following vaccination.

The study has two primary objectives; to evaluate the antibody response to the influenza vaccine in people who are vaccinated regularly and those vaccinated less regularly; the second is to evaluate circulating follicular helper T cells (TFH) in people who are vaccinated regularly and those vaccinated less regularly.

研究の種類

介入

入学 (実際)

20

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

  • アメリカ
    • Georgia
      • Atlanta、Georgia、アメリカ、30322
        • The Hope Clinic of the Emory Vaccine Center

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

20年～30年 (大人)

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:

  • Capable of informed consent and provision of written informed consent before any study procedures.
  • Capable of attending all study visits according to the study schedule.
  • Are in good health, as determined by medical history and targeted physical exam related to this history.
  • Oral temperature is less than 38 degrees Celsius.
  • Resting pulse rate is between 50 and 115 beats per minute.
  • Female subjects of childbearing age must have a negative urine pregnancy test within 24 hours before study vaccination.
  • Have received the influenza vaccine at least 3 of the past 5 years or have received the influenza vaccine in 2 or less of the past 5 years.

Exclusion Criteria:

  • Have an acute illness within 72 hours before vaccination.
  • Have any condition that, in the opinion of the principal investigator, would place the subject at an unacceptable risk of injury or confound the interpretation of the study results.
  • Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
  • Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.
  • Have known HIV, hepatitis B, or hepatitis C infection.
  • Have a known history of autoimmune disease.
  • Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.
  • Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.
  • Have received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to study vaccination.
  • Have planned vaccination with any vaccine during the 29-day duration of subject study participation.
  • Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.
  • Have donated blood or blood products within 30 days before study vaccination, plan to donate blood at any time during the 29-day duration of subject study participation, or plan to donate blood within 30 days after the last blood draw.
  • Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other compounds of the study vaccine.
  • Have a history of severe reactions following vaccination with influenza virus vaccines

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：非ランダム化
  • 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：Vaccination Naïve
Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
生物学的：2016-2017 Influenza Vaccine
Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
実験的：Vaccination Experienced
Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
生物学的：2016-2017 Influenza Vaccine
Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.

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
Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer
時間枠：Baseline (Day 1), Day 29
Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw. Titer for serum HAI antibodies will be calculated using the geometric mean. Change is defined as the difference in means from Day 1 to Day 29.
Baseline (Day 1), Day 29
Change in Mean Level of Circulating Follicular Helper T (TFH) Cells
時間枠：Up to 15 Days
TFH cells will be collected via blood draw. Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.
Up to 15 Days

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Mean Levels of Plasmablasts
時間枠：Up to 29 Days
Plasmablasts will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Up to 29 Days
Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29
時間枠：Baseline (Day 1) and Day 29
Memory B cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Baseline (Day 1) and Day 29
Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells
時間枠：Up to 29 Days
Antigen-specific Interleukin 2 (IL-2) producing cluster of differentiation 4 (CD4)+ T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Up to 29 Days
Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells
時間枠：Up to 29 Days
CD8+T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Up to 29 Days

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

Emory University

捜査官

  • 主任研究者：Mark Mulligan, MD、Emory University

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7月1日

一次修了 (実際)

2016年10月18日

研究の完了 (実際)

2016年12月1日

試験登録日

最初に提出

2016年8月4日

QC基準を満たした最初の提出物

2016年8月18日

最初の投稿 (見積もり)

2016年8月23日

学習記録の更新

投稿された最後の更新 (実際)

2018年12月12日

QC基準を満たした最後の更新が送信されました

2018年12月11日

最終確認日

2018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

  • IRB00090196

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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