This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.
Lung or kidney transplant recipients undergoing chronic immunosuppressive therapy, who received 1 (IC\_1 group) and 2 (IC\_2 group) doses of the adjuvanted RSVPreF3 vaccine in the RSV OA=ADJ-023 study \[parent study; NCT05921903\], will receive an additional dose of the adjuvanted RSVPreF3 vaccine in the current study. As pre-assigned in protocol, the participants that received 1 dose and 2 doses of adjuvanted RSVPreF3 vaccine in the parent study will be analysed separately in the current study for the immune response analyses, and under an overall group (IC Revaccination group) for the demographic and safety analyses.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
203
1 dose of adjuvanted RSVPreF3 vaccine administered intramuscularly at Visit 1 (Day 1).
GSK Investigational Site
Lexington, Kentucky, United States
RECRUITINGGSK Investigational Site
St Louis, Missouri, United States
RECRUITINGGSK Investigational Site
St Louis, Missouri, United States
RECRUITINGGSK Investigational Site
Omaha, Nebraska, United States
RSV-A neutralizing titers expressed as Geometric mean titers (GMTs)
RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60). GMT is calculated by taking the anti-log of the mean of the log titer transformations.
Time frame: At Visit 1 (Day 1) of the current study
RSV-B neutralizing titers expressed as GMTs
RSV-B neutralizing titers are given as group GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
Time frame: At Visit 1 (Day 1) of the current study
RSV-A neutralizing titers expressed as Mean geometric increase (MGI)
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 1 over titers observed 30 days post last dose in the RSV OA=ADJ-023 parent study).
Time frame: At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
RSV-B neutralizing titers expressed as MGI
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 1 over titers observed 30 days post last dose in the RSV OA=ADJ-023 parent study).
Time frame: At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
RSV-A neutralizing titers expressed as GMTs
RSV-A neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
Time frame: At Visit 2 (Day 31) of the current study
RSV-B neutralizing titers expressed as GMTs
RSV-B neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
Time frame: At Visit 2 (Day 31) of the current study
RSV-A neutralizing titers expressed as GMTs
RSV-A neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
Time frame: At Visit 3 (Day 180) of the current study
RSV-B neutralizing titers expressed as GMTs
RSV-B neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
Time frame: At Visit 3 (Day 180) of the current study
GMT ratio of RSV-A neutralizing titers
RSV-A neutralizing titers are given as group GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
Time frame: At Visit 1 (Day 1) of the current study
GMT ratio of RSV-B neutralizing titers
RSV-B neutralizing titers are given as group GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.
Time frame: At Visit 1 (Day 1) of the current study
RSV-A neutralizing titers expressed as MGI
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at Visit 1, and Visit 3 over Visit 1).
Time frame: At Visit 2 (Day 31) over Visit 1 (Day 1) and at Visit 3 (Day 180) over Visit 1 (Day 1) [each visit of the current study]
RSV-B neutralizing titers expressed as MGI
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at Visit 1, and Visit 3 over Visit 1).
Time frame: At Visit 2 (Day 31) over Visit 1 (Day 1) and at Visit 3 (Day 180) over Visit 1 (Day 1) [each visit of the current study]
RSV-A neutralizing titers expressed as MGI
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at 30 days post last dose in the RSV OA=ADJ-023 parent study).
Time frame: At Visit 2 (Day 31) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
RSV-B neutralizing titers expressed as MGI
MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at 30 days post last dose in the RSV OA=ADJ-023 parent study).
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GSK Investigational Site
New York, New York, United States
RECRUITINGGSK Investigational Site
Pittsburgh, Pennsylvania, United States
RECRUITINGGSK Investigational Site
Temple, Texas, United States
RECRUITINGGSK Investigational Site
Herston, Queensland, Australia
RECRUITINGGSK Investigational Site
Edmonton, Alberta, Canada
RECRUITINGGSK Investigational Site
Vancouver, British Columbia, Canada
RECRUITING...and 19 more locations
Time frame: At Visit 2 (Day 31) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study
Number of participants reporting each solicited administration site event
Solicited administration site events assessed are pain, redness and swelling.
Time frame: Visit 1 (Day 1 [day of revaccination]) to Day 7 of the current study
Number of participants reporting each solicited systemic event
Solicited systemic events assessed are fever, headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness).
Time frame: Visit 1 (Day 1 [day of revaccination]) to Day 7 of the current study
Number of participants reporting unsolicited adverse events (AEs)
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs.
Time frame: Visit 1 (Day 1 [day of revaccination]) to Day 30 of the current study
Number of participants reporting any serious adverse events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of relation to study vaccination.
Time frame: Visit 1 (Day 1 [day of revaccination] to Visit 3 (Day 180) of the current study
Number of participants reporting related SAEs and fatal SAEs
Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.
Time frame: Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study
Number of participants reporting any Potential immune-mediated disease (pIMDs) and related pIMDs
pIMDs are a subset of Adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.
Time frame: Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study
Number of participants reporting AESIs specific to kidney and lung SOT patients
AESIs specific to kidney and lung SOT patients include signs of transplant/allograft rejection.
Time frame: Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study