The purpose of this phase 3 study is to learn the safety, tolerability and immunogenicity of revaccination with RSVpreF at approximately 1-, 2-, and 3-year intervals to inform the revaccination interval in immunocompromised adults. This study is seeking participants who are 18 years of age and older and will be grouped based on prior RSV vaccination history. Participants are required to be immunocompromised per study protocol. All participants in this study will receive 1 shot to their arm of a RSVPreF vaccine. Participants will take part in this study for about 12 months and will need to visit the clinical study site at least 4 times.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
440
RSVpreF Vaccine
Kaiser Foundation Hospital LAMC
Los Angeles, California, United States
RECRUITINGKaiser Permanente Los Angeles Medical center
Los Angeles, California, United States
RECRUITINGKaiser Permanente
Los Angeles, California, United States
RECRUITINGGeorge Washington University
Washington D.C., District of Columbia, United States
RECRUITINGThe Hope Clinic of Emory University
Decatur, Georgia, United States
RECRUITINGNYU Langone Health Vaccine Center
New York, New York, United States
RECRUITINGRochester Clinical Research
Rochester, New York, United States
RECRUITINGDuke Vaccine and Trials Unit
Durham, North Carolina, United States
NOT_YET_RECRUITINGDuke Clinics 2F, 2G
Durham, North Carolina, United States
NOT_YET_RECRUITINGAltoona Center for Clinical Research
Duncansville, Pennsylvania, United States
NOT_YET_RECRUITINGPercentage of participants reporting local reactions
Time frame: For up to 7 days after vaccination
Percentage of participants reporting systemic events
Time frame: For up to 7 days after vaccination
Percentage of participants reporting adverse events
Time frame: Through 1 month after vaccination
Percentage of participants reporting newly diagnosed chronic medical conditions
Time frame: Through 12 months after vaccination
Percentage of participants reporting serious adverse events
Time frame: Through 12 months after vaccination
Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titer (GMT)
Time frame: Before vaccination, 1 month, 6 months and 12 months after vaccination
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
Time frame: Before vaccination, 1 month, 6 months and 12 months after vaccination
Seroresponse rate of NTs for RSV A and RSV B
Time frame: 1 month after revaccination
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