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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term care facility residents | Experimental | Licensed RSV vaccine IM x 1. Specific product to be determined availability at the facility as SOC |
|
| community dwelling adults | Active Comparator | Licensed RSV vaccine IM x1. The proportion of specific products will be matched to the LTCF cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV vaccine | 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Falsey | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Long-term care facility residents | Licensed RSV vaccine IM x 1. Specific product to be determined availability at the facility as SOC 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 |
| FG001 | community dwelling adults | Licensed RSV vaccine IM x1. The proportion of specific products will be matched to the LTCF cohort 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Long-term care facility residents | Licensed RSV vaccine IM x 1. Specific product to be determined availability at the facility as SOC 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Geometric Mean | 95% Confidence Interval | fold change | 30 days |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Long-term care facility residents | Licensed RSV vaccine IM x 1. Specific product to be determined availability at the facility as SOC 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Falsey, MD | University of Rochester | 585-922-4339 | Ann_Falsey@URMC.Rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2024 | Feb 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 20, 2023 | Feb 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D022261 | Respiratory Syncytial Virus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Laboratory testing will be blinded to vaccine and study cohort
|
| 30 days |
| RSV infection before vaccination |
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| BG001 | community dwelling adults | Licensed RSV vaccine IM x1. The proportion of specific products will be matched to the LTCF cohort 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Number of participants with diabetes mellitus | Count of Participants | Participants |
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| Number of participants with coronary artery disease | Count of Participants | Participants |
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| Number of participants with congestive heart failure | Count of Participants | Participants |
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| Number of participants with obstructive pulmonary disease | Count of Participants | Participants |
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| Number of participants with Asthma | Count of Participants | Participants |
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| Number of participants with hypertension | Count of Participants | Participants |
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| Number of participants with chronic kidney disease | Count of Participants | Participants |
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| Number of participants with cerebrovascular accident | Count of Participants | Participants |
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| Number of participants with dementia | Count of Participants | Participants |
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| Number of participants with cancer | Count of Participants | Participants |
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| Mean number of medical conditions | Mean | Standard Deviation | number of medical conditions |
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| OG001 | community dwelling adults | Licensed RSV vaccine IM x1. The proportion of specific products will be matched to the LTCF cohort 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 |
|
|
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| Primary | 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. | Posted | Geometric Mean | 95% Confidence Interval | fold change | 30 days |
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| Primary | 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. | Posted | Geometric Mean | 95% Confidence Interval | fold change | 30 days |
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| Secondary | 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 | Posted | Geometric Mean | 95% Confidence Interval | proportion of A2 to Fa | 30 days |
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| 76 |
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| EG001 | community dwelling adults | Licensed RSV vaccine IM x1. The proportion of specific products will be matched to the LTCF cohort 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 | 0 | 76 | 0 | 76 | 0 | 76 |
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