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

NCT ID: NCT06077149

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-07
• Study Completion Date: 2024-11-01

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

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.

Conditions

Respiratory Syncytial Virus (RSV)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Long-term care facility residents

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

Group Type: EXPERIMENTAL

RSV vaccine

Intervention Type: 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

community dwelling adults

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

Group Type: ACTIVE_COMPARATOR

RSV vaccine

Intervention Type: 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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ann Falsey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann Falsey

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00008699

Identifier Type: -

Identifier Source: org_study_id