MedTrace Logo

Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons

NCT07050732 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-12-12

No results posted yet for this study

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

Conditions

  • Respiratory Syncytial Virus (RSV)

Interventions

BIOLOGICAL

Arexvy (2 doses total)

Arexvy at enrollment, Arexvy at Day 365

BIOLOGICAL

Arexvy (3 doses total)

Arexvy at enrollment, Day 60, and Day 365

BIOLOGICAL

Arexvy (1 dose total)

Arexvy at enrollment

OTHER

Placebo

Placebo vaccine at day 60

Sponsors & Collaborators

Principal Investigators

  • John Baddley, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-04
Primary Completion
2026-11-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07050732 on ClinicalTrials.gov