Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07050732
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Respiratory Syncytial Virus (RSV)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Arexvy (2 doses total) — BIOLOGICAL
    Arexvy at enrollment, Arexvy at Day 365
  • Arexvy (3 doses total) — BIOLOGICAL
    Arexvy at enrollment, Day 60, and Day 365
  • Arexvy (1 dose total) — BIOLOGICAL
    Arexvy at enrollment
  • Placebo — OTHER
    Placebo vaccine at day 60

Study Details

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

Key Dates

Start date
Dec 4, 2025
Status verified
Dec 2025
Primary completion
Nov 30, 2026
Completion
Apr 30, 2028

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm 1: Arexvy + Placebo
    One dose of adjuvanted RSVPreF3 (Arexvy) at enrollment followed by placebo vaccine at Day 60 plus a re-vaccination Arexvy dose at 1 year (Day 365)
  • Experimental: Arm 2: Arexvy + Arexvy
    One dose of adjuvanted RSVPreF3 (Arexvy) at enrollment followed by a second dose of Arexvy at Day 60 plus a re-vaccination Arexvy dose at 1 year (Day 365)
  • Experimental: Arm 3: Healthy Comparators
    One dose of adjuvanted RSVPreF3 (Arexvy) at enrollment

Primary Outcome Measure

Geometric Mean Titer (GMT) (ED60 RSV A and B) [ Time Frame: At 30 days post 1st and 2nd dose in Arm 1 and Arm 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21205
John Baddley, MD
[email protected]
443-287-1964
John Baddley, MD (PRINCIPAL_INVESTIGATOR)

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Johns Hopkins University· Baltimore, MD

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