This clinical trial is being done to learn more about how well a vaccine (Arexvy®) for respiratory syncytial virus, also known as RSV, works in people with weakened immune systems. The main questions it aims to answer are: * Does 1 or 2 doses of Arexvy work better in people with weakened immune systems? * What medical problems do participants have after receiving Arexvy? Participants with weakened immune systems will: * Receive 3 study vaccines over the course of 1 year * Keep a diary of symptoms for 7 days after each vaccine * Have 3 in-person follow up study visits for checkups and tests over the course of 1.5 years * Have 6 phone follow up study visits over the course of 1.5 years
People with weakened immune systems will be randomized to either: 1. Receive one dose of Arexvy followed by a placebo vaccine (sterile saline) 60 days later, or 2. Receive one dose of Arexvy followed by another dose of Arexvy 60 days later Both groups will also receive another dose of Arexvy 1 year after the first dose. A small group of people without weakened immune systems will also be enrolled in the study. This group will receive one dose of Arexvy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
170
Arexvy at enrollment, Arexvy at Day 365
Arexvy at enrollment, Day 60, and Day 365
Arexvy at enrollment
Placebo vaccine at day 60
Johns Hopkins University
Baltimore, Maryland, United States
RECRUITINGGeometric Mean Titer (GMT) (ED60 RSV A and B)
Immune response elicited by adjuvanted RSVPreF3 (Arexvy) in immunocompromised adults as determined by titers of neutralizing antibody estimated dilution 60 (ED60) against RSV A and B
Time frame: At 30 days post 1st and 2nd dose in Arm 1 and Arm 2
Immune response elicited by adjuvanted RSVPreF3 (Arexvy) in immunocompromised adults as determined by titers of neutralizing antibody ED60 against RSV A and B
Mean Geometric Increase (MGI): Geometric mean of individual ratio of post-vaccine ED60 of RSV A and B over baseline titer (also called Geometric Mean Fold Rise \[GMFR\])
Time frame: At 30 days post 2nd dose (Arm 2) and 30 days post 1st dose (Arm 1)
Proportion of participants reporting reactions at injection site
Solicited local reactions including pain at injection site, erythema, and swelling
Time frame: Within 7 days of study vaccine administration
Proportion of participants reporting systemic events
Solicited systemic events including headache, fever, myalgia, arthralgia
Time frame: Within 7 days of study vaccine administration
Proportion of participants reporting adverse events
Proportion of participants reporting adverse events
Time frame: Through 30 days after each study vaccine administration
Adverse events of special interest
Proportion of participants reporting adverse events of special interest
Time frame: From enrollment to last study visit, approximately 18 months for Arms 1 and 2 and 12 months for Arm 3
Serious adverse events
Proportion of participants reporting serious adverse events
Time frame: Through 6 months following each study vaccine administration
Individual titers (ED60) for RSV-A and RSV-B #1
GMT
Time frame: 30 days post one year re-vaccination (Arm 1 and Arm 2)
Individual titers (ED60) for RSV-A and RSV-B #2
GMT
Time frame: 30 days post 1st dose (Pooled Arm 1 and Arm 2; and Arm 3)
Individual titers (ED60) for RSV-A and RSV-B #3
GMFR
Time frame: 30 days post 1st dose (Pooled Arm 1 and Arm 2; and Arm 3)
Individual titers (ED60) for RSV-A and RSV-B #4
GMFR
Time frame: 30 days post 2nd dose (Arm 2)
Individual titers (ED60) for RSV-A and RSV-B #5
Seroresponse rate (% of participants with at least a 4-fold increase from baseline in RSV A and RSV B ED60)
Time frame: At 30 days after each study vaccine administration
Individual titers (ED60) for RSV-A and RSV-B #6
GMFR
Time frame: At 30 days post a one year re-vaccination (Arm 1 and Arm 2)
Cell mediated immunity (RSV F specific CD4+ and CD8+ T cell response (T cells producing ≥ 2 cytokines, expressed as % of live CD3+)) #1
Median cell mediated immunity (CMI)
Time frame: At 30 days post 2nd dose (Arm 2) and 30 days post 1st dose (pooled Arm 1 and 2; and Arm 3)
Cell mediated immunity (RSV F specific CD4+ and CD8+ T cell response (T cells producing ≥ 2 cytokines, expressed as % of live CD3+)) #2
Median CMI
Time frame: At 30 days post 1st dose (Pooled Arm 1 and Arm 2; and Arm 3)
Cell mediated immunity (RSV F specific CD4+ and CD8+ T cell response (T cells producing ≥ 2 cytokines, expressed as % of live CD3+)) #3
Median CMI
Time frame: At 30 days post one year re-vaccination (Arm 1 and Arm 2)
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