Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF)

Phase 4

Active, not recruiting

• Conditions: Respiratory Syncytial Virus (RSV)
• Interventions: Biological: RSV vaccine

• Registration Number: NCT06077149
• Lead Sponsor: University of Rochester

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-11
• Study Start: 2023-11-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• ≥60 years of age who live in skilled nursing facilities or reside independently in the community
• Life expectancy of >6 months, as assessed by the investigator
• Able to sign informed consent or to provide consent via a legally authorized representative (LAR)

Exclusion Criteria

• History of a current immunosuppressive condition or receipt of chemotherapy or other immunosuppressive or cytotoxic therapy, including chronic prednisone use of ≥ 20 mg/day for more than 14 days within 3 months of study vaccination
• History of hypersensitivity or reaction to any vaccine component
• Simultaneous administration of another vaccine (influenza, SARS-CoV-2) or within a 14-day window before or after intervention
• Previous receipt or intended receipt of an RSV vaccine outside the study
• Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
• Documented RSV infection within 2 months prior to study intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long-term care facility residents	RSV vaccine	Licensed RSV vaccine IM x 1. Specific product to be determined availability at the facility as SOC
community dwelling adults	RSV vaccine	Licensed RSV vaccine IM x1. The proportion of specific products will be matched to the LTCF cohort

Primary Outcome Measures

Name	Time	Method
mean peak serum neutralizing antibody against RSV	1 month	Microneutralization Assay (MNA): Serum neutralizing titers will be performed using an established microneutralization method for RSV A and B strains. Briefly, 2-fold serum dilutions are incubated with 75 plaque forming units of RSV for 30 min at room temperature followed by the addition of 104HEp-2cells in 96-well culture plates. After 3 days, the quantity of RSV antigen is determined by enzyme immunoassay using a monoclonal antibody to the RSV F protein. The neutralization titer is defined as the serum dilution that results in a 50% reduction in color development.

Secondary Outcome Measures

Name	Time	Method
mean peak serum binding antibody to RSV prefusion F protein against RSV A & B	1 month	Enzyme Immunoassay (EIA): Serum IgG titers to RSV F (prefusion) protein of group A and B RSV will be determined by enzyme immunoassay using established methods.Briefly, purified RSV proteins are coated to 96-well EIA plates to which serum 2-fold dilutions are added in duplicate. Bound antibody is detected with alkaline phosphatase-conjugated goat anti-human IgG antibody and substrate.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States