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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05534425
Acronym
GenX
Enrollment
160
Registered
2022-09-09
Start date
2022-09-26
Completion date
2027-08-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Virus Infection, RNA

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALGenX intergenerational mentoring program

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

Sponsors

University of California, Los Angeles
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Masking description

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

Intervention model description

Randomized to Immediate GenX intervention vs. Waitlist Control delayed intervention

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Concentration of Type I interferon antiviral activity (bioassay International Units / mL)10 monthsBlood 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.

Secondary

MeasureTime frameDescription
Respiratory virus antibody concentration (WHO international units BAU/mL)10 monthsRespiratory 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.
Pro-inflammatory cytokine concentration (pg/mL)10 monthsBlood 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSteven Cole, Ph.D.

Professor of Medicine & Psychiatry

PRINCIPAL_INVESTIGATORTeresa E Seeman, Ph.D.

Professor of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026