GenX Mentoring Program for Respiratory Virus Resistance

(GenX Trial)

Overseen By Teresa E Seeman, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Health condition risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for more details.

How does the GenX Mentoring Program for Respiratory Virus Resistance differ from other treatments?

The GenX Mentoring Program is unique because it focuses on intergenerational mentoring rather than traditional medical treatments like vaccines or drugs. This approach may offer a novel way to enhance immune resistance to respiratory viruses by leveraging social and psychological support, which is different from the typical focus on direct immune system stimulation seen in vaccines. ^{1 2 3 4 5}

Research Team

Steven Cole, Ph.D.

Principal Investigator

Professor of Medicine & Psychiatry

Teresa E Seeman, Ph.D.

Principal Investigator

Professor of Medicine

Eligibility Criteria

This trial is for African-American men and women over 50 living in South-Central Los Angeles who can pass basic literacy and cognitive tests. They must be part of the GenX mentoring program. Those with health conditions that could worsen by joining are excluded.

Inclusion Criteria

Reside in neighborhood of GenX schools (South-Central Los Angeles)

I am over 50 years old.

Pass basic literacy and cognitive function tests

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Intervention

Participants engage in the Generation Xchange (GenX) intergenerational mentoring program or parallel training/educational activities

3 months

Delayed Intervention

Participants in the Delayed GenX group commence the GenX program activity after 3 months

7 months

Follow-up

Participants are monitored for antiviral gene regulation, well-being, respiratory virus antibody concentration, pro-inflammatory cytokine concentration, antiviral cell prevalence, Type I interferon antiviral activity, loneliness, and depressive symptoms

10 months

Treatment Details

Interventions

• GenX intergenerational mentoring program

Trial Overview The study is testing if the Generation Xchange (GenX) mentoring program can boost natural resistance to viral infections like RNA viruses and coronavirus in older adults from a low-SES urban community.

Participant Groups

Group I: Immediate GenX Experimental Treatment 1 Intervention

Participants immediately commence GenX program activity (intergenerational mentoring)

Group II: Delayed GenX Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

ChAdOx1 nCoV-19 vaccination generates spike-specific CD8+ T cells in aged mice. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Heterologous ChAdOx1-BNT162b2 vaccination in Korean cohort induces robust immune and antibody responses that includes Omicron. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Immune-Mediated Mechanisms in Patients Testing Positive for SARS-CoV-2: Protocol for a Multianalysis Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Older adults lack SARS CoV-2 cross-reactive T lymphocytes directed to human coronaviruses OC43 and NL63. [2021]