Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons

Immunogenicity and Safety of Multiple-Dose Adjuvanted RSVPreF3 (Arexvy®) Vaccination Among Immunocompromised Persons

Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons (NCT07050732) is a Phase 2 interventional studying Respiratory Syncytial Virus (RSV), sponsored by Johns Hopkins University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Respiratory Syncytial Virus (RSV) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 170 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Respiratory Syncytial Virus (RSV) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Able to understand and provide willing to sign a consent form - 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: 1. 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 2. 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 3. 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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: 1. 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 2. 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 3. 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. Exclusion Criteria: * 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: 1. 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 2. 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 3. Healthy comparator (HC): * Any confirmed/suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive or cytotoxic therapy, based on medical history * Any other conditions which, in the opinion of the Investigator, may pose additional risks from participation in the study, may interfere with the individual's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Johns Hopkins University

Baltimore, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07050732), the sponsor (Johns Hopkins University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07050732 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07050732?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07050732?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07050732. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07050732. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.