Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 5:25 PM
Study NCT ID:
NCT07050732
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Immunogenicity and Safety of Multiple-Dose Adjuvanted RSVPreF3 (Arexvy®) Vaccination Among Immunocompromised Persons
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRIVE
Brief Summary:
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
* 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
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: