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SCIVAX: 慢性SCIにおける免疫機能不全とワクチン反応性のバイオマーカー (SCIVAX)

2026年11月2日 更新者：Ona Bloom、Northwell Health

慢性外傷性脊髄損傷者の免疫機能不全とワクチン反応性のバイオマーカー

The purpose of this observational research study is to better understand immune responses to vaccines against viruses (influenza or SARS-CoV2). The goal is to determine any differences in immune responses to vaccines in uninjured people and in people living with spinal cord injuries, who are typically at increased risk of infections.

調査の概要

状態

積極的、募集していない

条件

詳細な説明

The purpose of this research study is to measure a person's immune response to a vaccine by measuring types of circulating white blood cells (WBC) and the substances they produce in blood, including antibodies, proteins, and ribonucleic acids (the body's genetic blueprint for making proteins).

The research will study two populations: uninjured people and people living with spinal cord injury (SCI), who are often at increased risk of infections. We will measure and observe over time any differences in immune responses to vaccines between those groups or among people with SCI according to their injury severity or level.

The overall goal of this study is to increase knowledge of immune responses to vaccination against influenza virus that causes the flu, and to the SARS-CoV-2 virus that causes COVID-19. There is currently a lack of information about what influences individual responses to vaccines and why people with SCI are at typically at increased risk of infection. Results from this study may teach us how to improve vaccination strategies and other ways to fight infections in uninjured people and in people with SCI

研究の種類

観察的

入学 (推定)

140

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
    • New York
      • Manhasset、New York、アメリカ、11030
        • Northwell Health

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～89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

サンプリング方法

非確率サンプル

調査対象母集団

Participants will be adults (ages 18-89 years old) with SCI or who are uninjured controls who are electing to receiving flu or COVID-19 vaccines to promote their health.

説明

Inclusion Criteria

SCI Participant Inclusion Criteria: To be eligible for prospective enrollment, participants are required to meet the following inclusion criteria:

  • 18-89 years old with traumatic SCI
  • initial traumatic SCI >/=1 year from enrollment (DOD funded study)
  • initial traumatic SCI <1 year from enrollment (non-DOD funded pilot study)
  • American Spinal Injury Association (ASIA) classification grade A-D
  • Neurological Injury Level C1-T10
  • Demonstrate capacity to provide informed consent using the "teach back" method to verify understanding and appreciation of study objectives and procedures.

Exclusion Criteria

To be eligible for prospective enrollment, SCI participants are required to not meet the following exclusion criteria:

  • Stage III-IV pressure ulcers
  • Cancer, chemotherapy, neutropenia
  • Pregnancy or lactation
  • No known SCI
  • Autoimmune disease
  • Pre-existing neurological disease
  • History of dementia
  • Any other condition that would compromise their ability to provide informed consent
  • Any other condition that a study physician feels would preclude participation or be contraindicated

Uninjured Control Group:

Inclusion Criteria

Uninjured Control Participant Inclusion Criteria: To be eligible for prospective enrollment, participants are required to meet the following inclusion criteria:

  • 18-89 years old without traumatic SCI
  • Demonstrate capacity to provide informed consent using the "teach back" method to verify understanding and appreciation of study objectives and procedures.

Exclusion Criteria

To be eligible for prospective enrollment, uninjured control participants are required to not meet the following exclusion criteria:

  • Cancer, chemotherapy, neutropenia
  • Pregnancy or lactation
  • Autoimmune disease
  • Pre-existing neurological disease
  • History of dementia
  • Any other condition that would compromise their ability to provide informed consent
  • Any other condition that a study physician feels would preclude participation or be contraindicated

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

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

コホートと介入

グループ/コホート
Individuals with Chronic Spinal Cord Injury who receive either Flu or COVID-19 vaccine

18-89 years old with traumatic SCI, AIS grade A-D, Neurological injury level of C1-T10 who are choosing to receive a vaccine against the flu or COVID-19 and demonstrate capacity to provide informed consent.
Uninjured Controls who receive the Flu vaccine or COVID-19 vaccine

18-89 years old without traumatic Spinal Cord Injury (SCI) who are choosing to receive a vaccine against either the Flu or COVID-19 and demonstrate the capacity to provide informed consent.

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
mRNA transcript levels for genes expressed according to white blood cell type after flu vaccination
時間枠：0-28 days after flu vaccination

Serum samples will be used to determine if gene expression levels made by specific types of white blood cells are different between participant groups and within the SCI group by injury level and severity.
0-28 days after flu vaccination
Anti-flu antibody titers in response to vaccination
時間枠：0-28 days after flu vaccination

Serum samples will be used to determine antibody titers for anti-flu antibodies at baseline and after vaccination. These samples will be obtained to determine if vaccine responses are different between participant groups and within the SCI group by injury level and severity
0-28 days after flu vaccination

二次結果の測定

結果測定
メジャーの説明
時間枠
mRNA transcript levels for genes expressed according to white blood cell type after COVID-19 vaccination
時間枠：0-28 days after COVID-19 vaccination

Serum samples will be used to determine if gene expression levels made by specific types of white blood cells are different between participant groups and within the SCI group by injury level and severity.
0-28 days after COVID-19 vaccination
Anti-COVID-19 antibody titers in response to vaccination
時間枠：0-28 days after COVID-19 vaccination

Serum samples will be used to determine antibody titers for anti-COVID-19 antibodies at baseline and after vaccination. These samples will be obtained to determine if vaccine responses are different between participant groups and within the SCI group by injury level and severity
0-28 days after COVID-19 vaccination
Systemic inflammatory cytokine levels in response to vaccination
時間枠：0-28 days after vaccination

Serum samples will be used to determine systemic inflammatory cytokine levels at baseline and after flu or COVID-19 vaccination. These samples will be obtained to determine if cytokine levels are different between participant groups and within the SCI group by injury level and severity
0-28 days after vaccination

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

Northwell Health

協力者

United States Department of Defense
New York State Department of Health

捜査官

  • 主任研究者：Ona Bloom, PhD、Feinstein Institute for Medical Research; Northwell Health

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)

2023年3月31日

一次修了 (実際)

2026年9月30日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2023年5月10日

QC基準を満たした最初の提出物

2023年5月19日

最初の投稿 (実際)

2023年5月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年3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

  • 22-0787-FIMR

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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