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Respiratory Syncytial Virus (RSV)Phase 2STRIVENCT07050732

Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons

A Phase 2 study testing Arexvy (2 doses total), Arexvy (3 doses total) and Arexvy (1 dose total) in people with Respiratory Syncytial Virus (RSV), run by Johns Hopkins University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus (RSV)
What is being tested?
Arexvy (2 doses total), Arexvy (3 doses total) and Arexvy (1 dose total)
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
1 siteUnited States
Study dates
4 Dec 2025to Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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):
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  • 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.

Who cannot join

  • 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.
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  • 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
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

John Baddley, MD contact

443-287-1964

jbaddle1@jh.edu

United States1 site, 1 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21205

    John Baddley, MD, 443-287-1964, jbaddle1@jh.edu

    John Baddley, MD

    Recruiting

Other trials in United States

About this study

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

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
Read the 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.

Being tested
Arexvy (2 doses total), Arexvy (3 doses total), Arexvy (1 dose total), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arexvy (2 doses total)Biological

    Also called adjuvanted RSVPreF3

    Arexvy at enrollment, Arexvy at Day 365

  • Arexvy (3 doses total)Biological

    Also called adjuvanted RSVPreF3

    Arexvy at enrollment, Day 60, and Day 365

  • Arexvy (1 dose total)Biological

    Also called adjuvanted RSVPreF3

    Arexvy at enrollment

  • PlaceboOther

    Placebo vaccine at day 60

Study groups in NCT07050732
Study groupRoleWhat they receive
Arm 1: Arexvy + PlaceboExperimentalOne 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)
Receives: Biological: Arexvy (2 doses total); Other: Placebo
Arm 2: Arexvy + ArexvyExperimentalOne 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)
Receives: Biological: Arexvy (3 doses total)
Arm 3: Healthy ComparatorsExperimentalOne dose of adjuvanted RSVPreF3 (Arexvy) at enrollment
Receives: Biological: Arexvy (1 dose total)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At 30 days post 1st and 2nd dose in Arm 1 and Arm 2

  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])

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

Secondary outcomes (14)

  1. Proportion of participants reporting reactions at injection site

    Solicited local reactions including pain at injection site, erythema, and swelling

    Measured: Within 7 days of study vaccine administration

  2. Proportion of participants reporting systemic events

    Solicited systemic events including headache, fever, myalgia, arthralgia

    Measured: Within 7 days of study vaccine administration

  3. Proportion of participants reporting adverse events

    Proportion of participants reporting adverse events

    Measured: Through 30 days after each study vaccine administration

  4. Adverse events of special interest

    Proportion of participants reporting adverse events of special interest

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

  5. Serious adverse events

    Proportion of participants reporting serious adverse events

    Measured: Through 6 months following each study vaccine administration

  6. Individual titers (ED60) for RSV-A and RSV-B #1

    GMT

    Measured: 30 days post one year re-vaccination (Arm 1 and Arm 2)

  7. Individual titers (ED60) for RSV-A and RSV-B #2

    GMT

    Measured: 30 days post 1st dose (Pooled Arm 1 and Arm 2; and Arm 3)

  8. Individual titers (ED60) for RSV-A and RSV-B #3

    GMFR

    Measured: 30 days post 1st dose (Pooled Arm 1 and Arm 2; and Arm 3)

  9. Individual titers (ED60) for RSV-A and RSV-B #4

    GMFR

    Measured: 30 days post 2nd dose (Arm 2)

  10. Individual titers (ED60) for RSV-A and RSV-B #5

    Seroresponse rate (% of participants with at least a 4-fold increase from baseline in RSV A and RSV B ED60)

    Measured: At 30 days after each study vaccine administration

  11. Individual titers (ED60) for RSV-A and RSV-B #6

    GMFR

    Measured: At 30 days post a one year re-vaccination (Arm 1 and Arm 2)

  12. Cell mediated immunity (RSV F specific CD4+ and CD8+ T cell response (T cells producing ≥ 2 cytokines, expressed as % of live CD3+)) #1

    Median cell mediated immunity (CMI)

    Measured: At 30 days post 2nd dose (Arm 2) and 30 days post 1st dose (pooled Arm 1 and 2; and Arm 3)

  13. Cell mediated immunity (RSV F specific CD4+ and CD8+ T cell response (T cells producing ≥ 2 cytokines, expressed as % of live CD3+)) #2

    Median CMI

    Measured: At 30 days post 1st dose (Pooled Arm 1 and Arm 2; and Arm 3)

  14. Cell mediated immunity (RSV F specific CD4+ and CD8+ T cell response (T cells producing ≥ 2 cytokines, expressed as % of live CD3+)) #3

    Median CMI

    Measured: At 30 days post one year re-vaccination (Arm 1 and Arm 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study start4 Dec 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07050732
Sponsor's protocol ID
IRB00501702
Acronym
STRIVE
Status last verified
Nov 2026
First submitted
25 Jun 2025
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arexvy (2 doses total), Arexvy (3 doses total) and Arexvy (1 dose total) in people with Respiratory Syncytial Virus (RSV), run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact John Baddley, MD (443-287-1964, jbaddle1@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07050732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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