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

N/AEnrolling By InvitationNCT05534425

University of California, Los Angeles160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

160

Conditions

Virus Infection, RNA

Interventions

GenX intergenerational mentoring programBEHAVIORAL

GenX trains older adults to collaborate with K-3rd grade teachers in mentoring high-need elementary school students in core reading and math skills.

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Any health condition that would put participant at risk by enrollment/participation

Locations (1)

UCLA School of Medicine

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

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.

Time frame: 10 months

Secondary Outcomes

Respiratory virus antibody concentration (WHO international units BAU/mL)

Respiratory virus infection (cold, influenza, COVID) will be assessed by multiplex IgG serological assay (MesoScale Discovery V-PLEX COVID-19 Respiratory Panel 2; https://www.mesoscale.com/products/covid-19-respiratory-panel-2-igg-k15372u/). Concentrations are quantified as WHO international Binding Antibody Units / mL.

Time frame: 10 months

Pro-inflammatory cytokine concentration (pg/mL)

Blood plasma and blood cell culture supernatant fluids will be assayed for expression of pro-inflammatory cytokines (e.g., IL1B, IL6, TNF) using the MesoScale Discovery U-PLEX Macrophage M1 Combo 1 hu assay (https://www.mesoscale.com/products/u-plex-macrophage-m1-combo-1-human-k15336k/). Measurement units are pg of cytokine / mL.

Time frame: 10 months

Data from ClinicalTrials.gov

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