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

• Sponsor: University of Rochester (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06077149
• Collaborator: (none)
• Enrollment: 152
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 12.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus (RSV)	Biological: RSV vaccine	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 152 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Laboratory testing will be blinded to vaccine and study cohort
• Primary Purpose: Prevention
• Official Title: A Comparison of Immunogenicity of Licensed RSV Vaccines in Residents of Long-Term Care Facilities (LTCF) to Community-dwelling Older Adults
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ann Falsey, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT06077149
• Other Study ID Numbers: STUDY00008699
• First Posted: Oct 11, 2023
• Last Update Posted: Oct 13, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 13, 2023