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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Syncytial Virus (RSV)

Intervention / Treatment
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* Biological: RSV vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean peak serum neutralizing antibody against RSV | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean peak serum binding antibody to RSV prefusion F protein against RSV A & B | 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. | 1 month |