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

NCT06077149 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00008699
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (3)

• Geometric Mean Fold Rise Against RSV Fa Protein

  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 Fa protein. The geometric mean fold rise is the neutralizing antibody titer at day 30 divided by the neutralizing antibody titer at day 0. Calculated as the geometric mean of the fold rise (post-vaccination titer divided by baseline titer) across participants.

  30 days

• Geometric Mean Fold Rise Against RSV Fb Protein

  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 Fb protein. The geometric mean fold rise is the neutralizing antibody titer at day 30 divided by the neutralizing antibody titer at day 0. Calculated as the geometric mean of the fold rise (post-vaccination titer divided by baseline titer) across participants.

  30 days

• Geometric Mean Fold Rise Against RSV A2 Protein

  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 A2 protein. The geometric mean fold rise is the neutralizing antibody titer at day 30 divided by the neutralizing antibody titer at day 0. Calculated as the geometric mean of the fold rise (post-vaccination titer divided by baseline titer) across participants.

  30 days

Secondary Outcomes (1)

• Ratio of Fold Response of RSV A2 Titer to Fa Titer

  30 days

Study Arms (2)

Long-term care facility residents

EXPERIMENTAL

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

Biological: RSV vaccine

community dwelling adults

ACTIVE COMPARATOR

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

Biological: RSV vaccine

Interventions

RSV vaccine BIOLOGICAL

All participants will get either the Pfizer RSV vaccine (RSVpreF (ABRYSVO)) or the GSK RSV vaccine (RSVpreF (AREXVY)) at 120 ug of the RSV prefusion F antigen intramuscularly in the the non-dominant deltoid muscle. Long-term care facility residents will get whichever vaccine is available at the facility as part of standard of care. Community cohort will be matched proportionally

Long-term care facility residents; community dwelling adults

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Respiratory Syncytial Virus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Ann Falsey, MD
• Organization: University of Rochester

Ann_Falsey@URMC.Rochester.edu

585-922-4339

Study Officials

• Ann Falsey

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory testing will be blinded to vaccine and study cohort
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 11, 2023
• Study Start: November 7, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)