Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons

NCT07050732 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB00501702
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (2)

• Geometric 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

  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 \[GMFR\])

  At 30 days post 2nd dose (Arm 2) and 30 days post 1st dose (Arm 1)

Secondary Outcomes (14)

• Proportion of participants reporting reactions at injection site

  Within 7 days of study vaccine administration

• Proportion of participants reporting systemic events

  Within 7 days of study vaccine administration

• Proportion of participants reporting adverse events

  Through 30 days after each study vaccine administration

• Adverse events of special interest

  From enrollment to last study visit, approximately 18 months for Arms 1 and 2 and 12 months for Arm 3

• Serious adverse events

  Through 6 months following each study vaccine administration

Study Arms (3)

Arm 1: Arexvy + Placebo

EXPERIMENTAL

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)

Biological: Arexvy (2 doses total); Other: Placebo

Arm 2: Arexvy + Arexvy

EXPERIMENTAL

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)

Biological: Arexvy (3 doses total)

Arm 3: Healthy Comparators

EXPERIMENTAL

One dose of adjuvanted RSVPreF3 (Arexvy) at enrollment

Biological: Arexvy (1 dose total)

Interventions

Placebo OTHER

Placebo vaccine at day 60

Arm 1: Arexvy + Placebo

Arexvy (2 doses total) BIOLOGICAL

Arexvy at enrollment, Arexvy at Day 365

Also known as: adjuvanted RSVPreF3

Arm 1: Arexvy + Placebo

Arexvy (3 doses total) BIOLOGICAL

Arexvy at enrollment, Day 60, and Day 365

Also known as: adjuvanted RSVPreF3

Arm 2: Arexvy + Arexvy

Arexvy (1 dose total) BIOLOGICAL

Arexvy at enrollment

Also known as: adjuvanted RSVPreF3

Arm 3: Healthy Comparators

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and provide informed consent
• Willing and able to comply with the requirements and restrictions in the protocol, including study visits and study-related procedures
• Medically stable in the opinion of the Investigator at the time of first study vaccination
• Life expectancy ≥ 365 days in the opinion of the Investigator at the time of first study vaccination
• Included in at least one of the groups below:
• Cellular therapy recipients (CTR):
• Individuals ≥ 18 years of age at the time of first study vaccination
• History of at least one of the following: i. Autologous stem cell transplant received more than 90 days prior to first study vaccination, ii. Allogeneic stem cell transplant received more than 90 days prior to first study vaccination, iii. Chimeric antigen receptor T cell (CAR-T) therapy received more than 90 days prior to first study vaccination
• Solid organ transplant recipients (SOTR):
• Individuals ≥ 18 years of age at the time of first study vaccination
• Received an ABO-compatible, single-organ type, solid organ transplant (lung, heart, kidney, liver) at least 90 days prior to first study vaccination, and are on at least 2 systemic immunosuppressive agents at time of first study vaccination
• Healthy comparator (HC):
• Individuals ≥ 60 years of age at the time of first study vaccination or 50-59 years of age at the time of first study vaccination and at increased risk of severe RSV disease
• No history of (a) or (b) above, and considered healthy or with chronic and stable medical conditions in the opinion of the Investigator, without immune compromise
• Participants of childbearing potential if practicing adequate contraception or abstinence from 1 month prior to first study vaccination and agree to continue adequate contraception or abstinence through at least 1 month after last study vaccination. All participants of childbearing potential must have a negative pregnancy test on the day of first study vaccination, prior to administration.

You may not qualify if:

• Known history of hypersensitivity to any vaccine or history of a life-threatening reaction to a vaccine
• Previous vaccination with any licensed or investigational RSV vaccine
• Acute or chronic clinically significant/unstable neurological disease (such as uncontrolled seizures, strokes, Guillain-Barré Syndrome (GBS)
• Vaccination with any inactivated, subunit, or split influenza vaccine or COVID-19 vaccine within 14 days prior to first study vaccination, or vaccination with any other licensed or investigational vaccine within 30 days prior to first study vaccination
• Receipt of investigational or approved monoclonal antibodies against RSV within 90 days prior to first study vaccination
• Moderate or severe acute illness/infection (in opinion of the Investigator) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of first study vaccination. A prospective participant should not be enrolled in the study until the condition has resolved or the febrile event has subsided.
• Any medical condition that in the opinion of the Investigator would make intramuscular injection unsafe
• Receipt of immunoglobulins or plasma products within 90 days prior to first study vaccination
• Receipt of B-cell depleting medications (e.g., Rituximab, ocrelizumab, ofatumumab, belimumab, epratuzumab, antithymocyte globulin) within 90 days prior to first study vaccination
• Currently pregnant or breastfeeding or planning to become pregnant, discontinue contraception, or breastfeed during the study period
• Any of the following:
• Cellular therapy recipients (CTR):
• Graft-versus-host disease (GVHD) requiring systemic treatment with at least 0.5 mg/kg per day of prednisone or equivalent at time of first study vaccine
• Solid organ transplant recipients (SOTR):
• History of any of the following within 90 days prior to first study vaccination: allograft rejection, post-transplant lymphoproliferative disease, treatment for either of these conditions

Sponsors & Collaborators

• Johns Hopkins University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Interventions

arexvy

Study Officials

• John Baddley, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Baddley, MD

CONTACT

443-287-1964; jbaddle1@jh.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)