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

A Comparison of Immunogenicity of Licensed RSV Vaccines in Residents of Long-Term Care Facilities (LTCF) to Community-dwelling Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus (RSV)
• Intervention / Treatment: Biological: RSV vaccine

Detailed Description

This was an open label non-inferiority study to evaluate immunogenicity where all participants received either the Pfizer RSV Vaccine (ABRYSVO) or GSK RSV Vaccine (AREXVY) as part of Standard of Care (SOC). Hereafter, vaccines will be referred to as Pfizer and GSK.

The study was conducted at the University of Rochester Medical Center (URMC) Infectious Disease Research Clinic (IDRC) and 2 local LTCFs. Vaccinations were carried out between November and December 2023. LTCF A provided GSK vaccine and LTCF B provided Pfizer vaccine to their residents as part of SOC. The community cohort was divided equally to receive Pfizer and GSK to mirror the Pfizer and GSK vaccinations in LTCF. The study was reviewed and approved by the University of Rochester Institutional Review Board and leadership at the local LTCFs. Participants or their legally authorized representative (LAR) signed written informed consent. Verbal consent by LAR was also accepted given the minimal risk nature of the study.

Participants:

Inclusion criteria were intended to be broad with relatively few exclusions to reflect a real-life population in LTCF and the older adults in the community. Inclusion criteria included: ≥60 years of age living LTCF or residing independently in the community, planning to receive a SOC RSV vaccine, life expectancy of >6 months, able to sign informed consent or to provide consent via a LAR. Exclusions included: history of a current immunosuppressive condition or medications, history of hypersensitivity or reaction to any vaccine component, any routine vaccination within a 14-day window before or planned after RSV vaccination, previous receipt or intended receipt of an RSV vaccine outside the study, receipt of blood/plasma products or immunoglobulin within 60 days before RSV vaccination, and documented RSV infection within 2 months prior to enrollment.

Study Procedures:

Prior to any study procedures informed consent was obtained from the participant or LAR. At enrollment demographic and medical history data were collected. A clinical assessment including vital signs and a symptom directed targeted physical exam was performed. Ten 10cc of blood was collected. Vaccination in LTCF were performed by the staff at each facility per SOC and the vaccine product and date of vaccination recorded. Vaccination of the community cohort was performed in the IDRC at enrollment visit. Visit two was scheduled 28 to 42 days following vaccination at which time a second 10cc blood sample was collected and participants were queried about any intercurrent illnesses. Results of any viral testing performed as part of standard of care were recorded. If a participant had an intercurrent RSV infection prior to RSV vaccination and vaccination was deferred, visit 2 was scheduled 28 -42 days after infection was documented.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long-term care facility residents; Licensed RSV vaccine IM x 1. Specific product to be determined availability at the facility as SOC	Biological: RSV vaccine; 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
Active Comparator: community dwelling adults; Licensed RSV vaccine IM x1. The proportion of specific products will be matched to the LTCF cohort	Biological: RSV vaccine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of Fold Response of RSV A2 Titer to Fa Titer	the ratio of fold response of RSV A2 neutralizing titer to Fa IgG binding titers was calculated as a measure of the relative proportion of functional F antibody produced	30 days

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Ann Falsey, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Respiratory Syncytial Virus Vaccines
• Other Study ID Numbers: STUDY00008699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No