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

Respiratory Syncytial Virus (RSV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06077149
• Other study ID #: STUDY00008699
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 7, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: March 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus (RSV)

Intervention

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

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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