RSV Vaccine for Respiratory Syncytial Virus

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Rochester

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This clinical trial is studying the newly licensed RSV vaccines in adults over age 60 years living in long-term care facilities (nursing homes) by comparing the immune response to their vaccine to adults over age 60 years living in the community.

Research Team

Eligibility Criteria

This trial is for adults over 60 living in long-term care facilities or independently, with a life expectancy of more than 6 months. They must be able to consent themselves or through a representative. It's not for those with immune system issues, recent high-dose steroids, severe vaccine allergies, other vaccines close to the study period, prior RSV vaccination outside the study, or recent blood products or RSV infection.

Inclusion Criteria

I am 60 or older and live in a nursing facility or independently.

You are expected to live longer than half a year, based on the investigator's evaluation.

You are capable of signing informed consent or granting permission through a legally appointed representative.

Exclusion Criteria

History of hypersensitivity or reaction to any vaccine component

I haven't taken high-dose steroids or other immune-weakening drugs recently.

I have not received any vaccines 14 days before or after the trial intervention.

Treatment Details

Interventions

• RSV vaccine (Cancer Vaccine)

Trial Overview The trial is examining how effective newly licensed RSV vaccines are in older adults residing in nursing homes compared to those living on their own. The focus is on comparing the immune responses between these two groups after receiving the vaccine.

Participant Groups

Group I: Long-term care facility residents Experimental Treatment 1 Intervention

Licensed RSV vaccine IM x 1. Specific product to be determined availability at the facility as SOC

Group II: community dwelling adults Active Control 1 Intervention

Licensed RSV vaccine IM x1. The proportion of specific products will be matched to the LTCF cohort

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Kevin Koch

University of Rochester

Chief Executive Officer since 2020

PhD in Organic Chemistry from the University of Rochester

Brian Druker

University of Rochester

Chief Medical Officer since 2015

MD from Harvard Medical School