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临床试验/NCT05534425
NCT05534425Enrolling By Invitation不适用

Enhancing Innate Anti-Viral Resistance Through A Community-Based Intervention - Generation Xchange

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年9月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
160
试验地点
2
主要终点
Concentration of Type I interferon antiviral activity (bioassay International Units / mL)

研究概览

简要总结

This randomized controlled trial will test whether a recently developed community-based intergenerational mentoring program known as Generation Xchange (GenX) can enhance antiviral resistance in older African-American women and men in a low-SES urban community. Additional studies will identify the biological processes that promote resistance to respiratory virus infections and viral disease in older African-American women and men.

详细描述

This randomized controlled intervention trial (planned n=160) will test whether participation in the Generation Xchange (GenX) intergenerational mentoring program can reduces vulnerability to respiratory virus infections (COVID, influenzas, colds), increase antiviral immune activity (Type I interferon responses), and reduce inflammatory immune activity in older African-American women and men living in a socioeconomically disadvantaged urban community. Blood samples will also be collected to determine which biological factors are most important in protecting older African-Americans from respiratory virus infection, and which of those factors is affected by the GenX intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

盲法说明

All data collected, assayed, coded, and analyzed by researchers blind to study condition and participant identity

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participating in the GenX intergenerational mentoring program
  • All GenX mentors > 50 years of age are eligible to participate in this research
  • GenX program participation requires:
  • Reside in neighborhood of GenX schools (South-Central Los Angeles)
  • Pass basic literacy and cognitive function tests

排除标准

  • Any health condition that would put participant at risk by enrollment/participation

研究组 & 干预措施

Delayed GenX

Active Comparator

Participants engage in parallel training/educational activities, and subsequently commence GenX program activity after 3 months

干预措施: GenX intergenerational mentoring program (Behavioral)

Immediate GenX

Experimental

Participants immediately commence GenX program activity (intergenerational mentoring)

干预措施: GenX intergenerational mentoring program (Behavioral)

结局指标

主要结局

Concentration of Type I interferon antiviral activity (bioassay International Units / mL)

时间窗: 10 months

Blood cell production of Type I interferon activity will stimulated by exposure to a fixed dose of model viral protein (TruCulture Resiquimod R848 tubes) and quantifying Type I interferon concentration in the cell culture supernatant fluid using the standard Armstrong bioassay (Armstrong, J.A. Cytopathic effect inhibition assay for interferon: microculture plate assay. Methods in enzymology 78, 381-387 (1981).) Antiviral activity is quantified as International Units of Interferon activity / mL.

次要结局

  • Respiratory virus antibody concentration (WHO international units BAU/mL)(10 months)
  • Pro-inflammatory cytokine concentration (pg/mL)(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steve Cole, Ph.D.

Professor of Medicine and Psychiatry & Biobehavioral Sciences

University of California, Los Angeles

研究点 (2)

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