Trial Outcomes & Findings for Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF) (NCT NCT06077149)
NCT ID: NCT06077149
Last Updated: 2025-10-27
Results Overview
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.
COMPLETED
PHASE4
152 participants
30 days
2025-10-27
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
|
Overall Study
COMPLETED
|
70
|
76
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
RSV infection before vaccination
|
3
|
0
|
Baseline Characteristics
Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF)
Baseline characteristics by cohort
| Measure |
Long-term care facility residents
n=76 Participants
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
|
community dwelling adults
n=76 Participants
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
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.6 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
72.6 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
75.9 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
76 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Number of participants with diabetes mellitus
|
25 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Number of participants with coronary artery disease
|
28 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Number of participants with congestive heart failure
|
20 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Number of participants with obstructive pulmonary disease
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Number of participants with Asthma
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Number of participants with hypertension
|
61 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Number of participants with chronic kidney disease
|
24 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Number of participants with cerebrovascular accident
|
24 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Number of participants with dementia
|
33 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Number of participants with cancer
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Mean number of medical conditions
|
5.6 number of medical conditions
STANDARD_DEVIATION 1.8 • n=5 Participants
|
2.2 number of medical conditions
STANDARD_DEVIATION 1.8 • n=7 Participants
|
3.9 number of medical conditions
STANDARD_DEVIATION 2.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysMicroneutralization 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.
Outcome measures
| Measure |
Long-term care facility residents
n=70 Participants
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
|
community dwelling adults
n=76 Participants
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
|
|---|---|---|
|
Geometric Mean Fold Rise Against RSV Fa Protein
|
12.5 fold change
Interval 12.0 to 12.9
|
9.9 fold change
Interval 9.8 to 9.9
|
PRIMARY outcome
Timeframe: 30 daysMicroneutralization 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.
Outcome measures
| Measure |
Long-term care facility residents
n=70 Participants
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
|
community dwelling adults
n=76 Participants
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
|
|---|---|---|
|
Geometric Mean Fold Rise Against RSV Fb Protein
|
11.0 fold change
Interval 10.5 to 11.6
|
8.7 fold change
Interval 8.6 to 8.8
|
PRIMARY outcome
Timeframe: 30 daysMicroneutralization 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.
Outcome measures
| Measure |
Long-term care facility residents
n=70 Participants
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
|
community dwelling adults
n=76 Participants
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
|
|---|---|---|
|
Geometric Mean Fold Rise Against RSV A2 Protein
|
15.5 fold change
Interval 15.2 to 16.0
|
12.8 fold change
Interval 12.6 to 12.9
|
SECONDARY outcome
Timeframe: 30 daysthe 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
Outcome measures
| Measure |
Long-term care facility residents
n=70 Participants
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
|
community dwelling adults
n=76 Participants
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
|
|---|---|---|
|
Ratio of Fold Response of RSV A2 Titer to Fa Titer
|
1.15 proportion of A2 to Fa
Interval 1.0 to 1.32
|
1.18 proportion of A2 to Fa
Interval 1.07 to 1.29
|
Adverse Events
Long-term care facility residents
community dwelling adults
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place