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Healthy VolunteersPhase 1NCT06556147

A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults

A Phase 1 study testing VXB-241 60 mcg (Low Dose), VXB-241 120 mcg (Medium Dose) and VXB-241 240 mcg (Medium-high Dose) in people with Healthy Volunteers, run by Sanofi at 4 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The main purposes of this study are to assess the safety, reactogenicity and immunogenicity of 4 dose levels of the bivalent combination Respiratory Syncytial Virus (RSV) / human Metapneumovirus (hMPV) vaccine candidate VXB-241 when administered as a single-dose regimen to healthy adults 60 to 83 years of age, and to… Read more about this study

Who is it for?
Ages 18 to 83 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
VXB-241 60 mcg (Low Dose), VXB-241 120 mcg (Medium Dose) and VXB-241 240 mcg (Medium-high Dose)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
4 sitesAustralia
Study dates
13 Aug 2024to May 2027
Phase
Phase 1
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 to 83 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female, 18 to 40 years of age (yoa) (younger adult) or 60 to 83 yoa (older adult).
  • Evidence of signed and dated participant informed consent form (PICF) prior to any study procedure, indicating that the participant has been informed of all pertinent aspects of the study.
  • Willingness and ability to comply with the planned study visits and calls, procedures, and restrictions for the duration of the study.
  • Good health, which allows for pre-existing well-controlled and low impact chronic diseases, except for the diseases listed in the exclusion criteria. A disease is defined as well-controlled and low impact if it did not require meaningful change in therapy or unplanned medical visits in the previous 3 months and allows participant's primary responsibility for self-care and daily living activities.
  • Non-smoker or occasional smoker, defined as smoking less than 10 nicotine-containing cigarettes/ vapes/cigars/pipe fills per week.
  • Contraception: heterosexually active participants of childbearing potential able and willing to use a double contraceptive method for at least 4 weeks before and 12 weeks after the first IMP injection at Visit 2 (all participants of childbearing potential) and second IMP injection at Visit 6 (male older adults of childbearing potential).
  • Body Mass Index (BMI) >=17.0 kilogram per square meter (kg/m^2) and less than or equal to (<=) 35.0 kg/m^2.

Who cannot join

  • History of RSV and/or hMPV infection affecting the participant and/or the participant's household in the previous 12 months.
  • History of autoimmune disease (AID) or potentially autoimmune disease (pAID) requiring therapeutic intervention, even if stable and well controlled, including but not limited to systemic lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, temporal arteritis, psoriasis, insulin-dependent diabetes mellitus, celiac disease.
  • Confirmed or suspected immunodeficiency, even if stable and well controlled.
  • Ongoing severe asthma. Other allergic diseases (example, allergic rhinitis, atopic dermatitis / eczema, mild to moderate asthma, food allergies, are allowed at the investigator's or delegate's discretion).
  • History of severe allergic reaction (example, anaphylaxis) to any substance, including vaccine components and latex.
  • History of severe adverse event (AEs) associated with vaccine administration.
Show all 26Show fewer
  • Ongoing disorders of coagulation, which contraindicate IM injections.
  • Donation or loss of >=500 milliliter (mL) whole blood on the previous 2 months and/or donation of plasma in the previous 1 week, and/or intention to donate blood or plasma during the study.
  • Positive serum test results for serum human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection and/or documented HIV, HVB or HVC infection.
  • Other poorly controlled and/or impactful chronic disease. A disease is defined as poorly controlled if it required meaningful change in therapy and/or unplanned medical visits in the previous 3 months. A disease is defined as impactful if it has a meaningful impact on participant's self-care and/or activities of daily living.
  • Disease expected to prevent completion of the study (that is to rapidly deteriorate within the timeframe of the study).
  • Prior treatments.
  • Licensed RSV vaccine or investigational RSV and/or hMPV vaccine received at any time.
  • Investigational drug or vaccine received in the previous 6 months.
  • Chemotherapy, radiotherapy, and/or other immunosuppressive medication including biologics received in the previous 6 months.
  • Immunoglobulins G (IgGs) or any blood product received in the previous 3 months.
  • Systemic corticosteroids (oral/intravenous/intramuscular) at doses equivalent to >=20 mg prednisone received for >=14 days, even if not consecutive, during the previous 3 months. Inhaled/nebulized, intra-articular, intra-bursal, skin and eye topical corticosteroids are permitted.
  • Clinically meaningful abnormal finding from physical examination, vital sign assessment, electrocardiogram (ECG), safety laboratory test results. If deemed appropriate, the investigator or delegate may repeat these assessments.
  • History of alcohol abuse in the previous year and/or positive alcohol breath test.
  • History of recreational drug abuse in the previous year and/or positive test for drugs of abuse, unless there is an explanation acceptable to the investigator (example, the participant has informed in advance that he/she consumed a prescription or over-the-counter product that contained the detected drug).
  • Intention to participate in any investigational drug/vaccine clinical trial at any time throughout the planned duration of this study.
  • Presence of tattoo, scarring, skin discoloration, or any other skin disturbances at the injection site which may interfere with effective assessment of the injection site.
  • Intention to move to a location that would prevent participating in the study until study end.
  • Limited to premenopausal female participants: breastfeeding, positive pregnancy test or intention to become pregnant during the first 3 months of the study.
  • Any other reason which would prevent the participant from participating in the study or interfere with the participant's compliance with study procedures.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Veritus Research

    Bayswater, Victoria, 3153

  • University of the Sunshine Coast

    Morayfield, Queensland, 4506

  • University of the Sunshine Coast

    Sippy Downs, Queensland, 4556

  • University of the Sunshine Coast

    South Brisbane, Queensland, 4101

Other trials in Australia

About this study

Official title: A Phase 1 Randomized, Placebo- and Active-controlled, Observer-blind Study in Older Adults With Run-in in Young Adults to Evaluate the Safety, Reactogenicity, and Immunogenicity of Four Dose Levels of VXB-241, A Molecular Clamp Stabilized Prefusion F Glycoprotein Subunit Bivalent Vaccine Candidate for the Prevention of Lower Respiratory Tract Disease Caused by Respiratory Syncytial Virus (RSV) And Human Metapneumovirus (HMPV)

The main purposes of this study are to assess the safety, reactogenicity and immunogenicity of 4 dose levels of the bivalent combination Respiratory Syncytial Virus (RSV) / human Metapneumovirus (hMPV) vaccine candidate VXB-241 when administered as a single-dose regimen to healthy adults 60 to 83 years of age, and to assess the impact of revaccination approximately 1 year later.

Read the detailed description

This is a multi-center study in older adults with run-in in younger adults to evaluate the safety, reactogenicity, and immunogenicity of 4 dose levels of VXB-241. The total planned sample size is 136 randomized participants, composed of 16 younger adults 18 to 40 years of age and 120 older adults 60 to 83 years of age who are in good health, which allows for many chronic conditions, if well controlled and compatible with self-sufficiency in self-care and daily living activities.

Recruitment will be in 2 stages:

  • Stage 1 (Sequential Cohort Stage, N=32). Four cohorts (Cohorts 1 to 4), each of 8 participants, will be enrolled sequentially. In each cohort, 4 younger adults will be enrolled first, followed by 4 older adults. Younger and older adult participants will be randomized with 3:1 ratio to VXB-241 at increasing dose (60 microgram (mcg), 120 mcg, 240 mcg, 480 mcg in Cohorts 1 to 4, respectively) or Placebo. A Safety Monitoring Committee will make recommendations on escalation from one cohort to the next and from Stage 1 to Stage 2 based on safety and reactogenicity data collected over 1 week after investigational medicinal product (IMP) dosing.
  • Stage 2 (Concurrent Group Stage, N=104). Older adult participants will be randomized concurrently with unequal randomization to 1 of 6 treatment groups: VXB-241 60 mcg (Group 1a), VXB-241 120 mcg (1b), VXB-241 240 mcg (1c), VXB-241 480 mcg (1d), commercial RSV vaccine Arexvy (2a), Placebo (3a). The planned total sample size of each treatment group, combining Stage 1 and Stage 2, is N=20.

The overall planned duration of the study is approximately 6 months for younger adult participants and approximately 2 years for older adult participants.

At the end of the 1st year, older adult participants will receive a second IMP injection (revaccination): participants who received VXB-241 (at any dose) will be assigned 1:1 to revaccination with VXB-241 (Group 1e) or Placebo (1f); participants who received Arexvy will be revaccinated with placebo (2b); participants who received Placebo will be revaccinated with VXB-241 (3b). The dose of VXB-241 for revaccination will be 240 mcg (RSV preF 120 mcg + HMPV preF 120 mcg) (based on 1 month post 1st IMP injection results).

Being tested
VXB-241 60 mcg (Low Dose), VXB-241 120 mcg (Medium Dose), VXB-241 240 mcg (Medium-high Dose), VXB-241 480 mcg (High Dose), VXB-241 240 mcg
Keywords
Human Metapneumovirus, Respiratory Syncytial Virus, Vaccine

What participants receive

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

  • VXB-241 60 mcg (Low Dose)Biological

    VXB-241 low dose, single, IM injection.

  • VXB-241 120 mcg (Medium Dose)Biological

    VXB-241 medium dose, single, IM injection.

  • VXB-241 240 mcg (Medium-high Dose)Biological

    VXB-241 medium-high dose, single, IM injection.

  • VXB-241 480 mcg (High Dose)Biological

    VXB-241 high dose, single, IM injection.

  • VXB-241 240 mcgBiological

    VXB-241 240 mcg (RSV preF 120 mcg + hMPV preF 120 mcg) (based on 1 month post 1st IMP injection results) single, IM injection.

  • PlaceboOther

    Placebo, single, IM injection.

  • Arexvy 120 mcgBiological

    Arexvy 120 mcg, single, IM injection.

Study groups in NCT06556147
Study groupRoleWhat they receive
Stage 1, Day 1, Sequential Cohort 1ExperimentalYounger and older adult participants will receive VXB-241 60 mcg (low dose) or Placebo, intramuscularly (IM), once on Day 1.
Receives: Biological: VXB-241 60 mcg (Low Dose); Other: Placebo
Stage 1, Day 1, Sequential Cohort 2ExperimentalYounger and older adult participants will receive VXB-241 120 mcg (medium dose) or Placebo, IM, once on Day 1.
Receives: Biological: VXB-241 120 mcg (Medium Dose); Other: Placebo
Stage 1, Day 1, Sequential Cohort 3ExperimentalYounger and older adult participants will receive VXB-241 240 mcg (medium-high dose) or Placebo, IM, once on Day 1.
Receives: Biological: VXB-241 240 mcg (Medium-high Dose); Other: Placebo
Stage 1, Day 1, Sequential Cohort 4ExperimentalYounger and older adult participants will receive VXB-241 480 mcg (high dose) or Placebo, IM, once on Day 1.
Receives: Biological: VXB-241 480 mcg (High Dose); Other: Placebo
Stage 2, Day 1, Concurrent Group 1aExperimentalOlder adult participants will receive VXB-241 60 mcg (low dose), IM, once on Day 1.
Receives: Biological: VXB-241 60 mcg (Low Dose)
Stage 2, Day 1, Concurrent Group 1bExperimentalOlder adult participants will receive VXB-241 120 mcg (medium dose), IM, once on Day 1.
Receives: Biological: VXB-241 120 mcg (Medium Dose)
Stage 2, Day 1, Concurrent Group 1cExperimentalOlder adult participants will receive VXB-241 240 mcg (medium-high dose), IM, once on Day 1.
Receives: Biological: VXB-241 240 mcg (Medium-high Dose)
Stage 2, Day 1, Concurrent Group 1dExperimentalOlder adult participants will receive VXB-241 480 mcg (high dose), IM, once on Day 1.
Receives: Biological: VXB-241 480 mcg (High Dose)
Stage 2, Day 1, Concurrent Group 2aActive comparatorOlder adult participants will receive Arexvy 120 mcg, IM, once on Day 1.
Receives: Biological: Arexvy 120 mcg
Stage 2, Day 1, Concurrent Group 3aPlacebo comparatorOlder adult participants will receive Placebo, IM, once on Day 1.
Receives: Other: Placebo
Group 1e: VXB-241 Revaccination in VXB-241 RecipientsExperimentalApproximately 50% of the older adult participants who received VXB-241 240 mcg, will receive VXB-241 240 mcg, IM, (based on 1 month post 1st IMP injection results), once on Day 364 in the second year of the study.
Receives: Biological: VXB-241 240 mcg
Group 1f: Placebo Revaccination in VXB-241 RecipientsPlacebo comparatorApproximately 50% of the older adult participants who received VXB-241 (any dose level), will receive Placebo, IM, once on Day 364 in the second year of the study.
Receives: Other: Placebo
Group 2b: Placebo Arexvy RevaccinationPlacebo comparatorAll older adult participants who received Arexvy 120 mcg will receive Placebo revaccination, IM, once on Day 364 in the second year of the study.
Receives: Other: Placebo
Group 3b: VXB-241ExperimentalAll older adult participants who received Placebo will receive VXB-241 240 mcg (based on 1 month post 1st IMP injection results), IM, once on Day 364 in the second year of the study.
Receives: Biological: VXB-241 240 mcg

What is being measured

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

  1. Proportion of Older Adult Participants With 1 or More Unsolicited AEs

    Measured: 1 month after first IMP injection (Days 1 to 30)

  2. Proportion of Older Adult Participants With 1 or More Solicited AEs

    Measured: 7 days after first IMP injection (Days 1 to 8)

  3. Geometric Mean Fold Increase (GMFI) of RSV-A, RSV-B, hMPV-A, and hMPV-B Serum Neutralizing Antibody Titers in Older Adults

    GMFI is defined as geometric mean of ratios of specific antibody titer/concentration at each post-vaccination time point over pre-vaccination baseline.

    Measured: Pre-injection baseline to 1 month (Day 30) after first IMP injection

  4. Ratio of Dose-response Curves for GMFIs of RSV-A, RSV-B, hMPV-A and hMPV-B Serum Neutralizing Antibody Titers in Older Adults

    Ratio of VXB-241 dose versus GMFI of RSV-A, RSV-B, hMPV-A and hMPV-B will be calculated.

    Measured: Pre-injection baseline to 1 month (Day 30) after first IMP injection

Secondary outcomes (16)

  1. Proportion of Older Adult Participants With 1 or More Unsolicited AEs and With 1 or More Severe Unsolicited AE

    Measured: 1 month after first IMP injection (Days 1 to 30) and 1 month after second IMP injection (revaccination, Days 364 to 394)

  2. Proportion of Older Adult Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and Premature Discontinuation Associated AEs (PDAEs)

    Measured: 1 month after first IMP injection (Days 1 to 30) and 1 month after second IMP injection (revaccination, Days 364 to394), and throughout follow-up (Days 1 to 720)

  3. Mean Change From Baseline for Abnormal and Severe Abnormal Hematology Laboratory Values for Hemoglobin in Older Adults

    Measured: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination

  4. Mean Change From Baseline for Abnormal and Severe Abnormal Hematology Laboratory Values for Red Blood Cells, White Blood Cells, and Platelet Count in Older Adults

    Measured: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination

  5. Mean Change From Baseline for Abnormal and Severe Abnormal Blood Chemistry Laboratory Values for Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Alkaline Phosphatase in Older Adults

    Measured: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination

  6. Mean Change From Baseline for Abnormal and Severe Abnormal Blood Chemistry Laboratory Values for Total Bilirubin, Creatinine, and Urea in Older Adults

    Measured: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination

  7. Proportion of Older Adult With Abnormal and Severe Abnormal Values for Hematology Laboratory Parameter

    Measured: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination)

  8. Proportion of Older Adult With Abnormal Values and Severe Abnormal Values for Blood Chemistry Laboratory Parameter

    Measured: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination)

  9. Proportion of Older Adult Participants With Solicited AEs

    Measured: 7 days after 2nd IMP injection (revaccination, Day 364 to 371)

  10. GMFI of RSV-A, RSV-B, hMPV-A, and hMPV-B Serum Neutralizing Antibody Titers in Older Adults

    Measured: Pre-injection baseline to 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

  11. Geometric Mean Titers (GMTs) of RSV-A, RSV-B, hMPV-A, and hMPV-B Serum Neutralizing Antibody Titers in Older Adults

    Measured: Pre-injection baseline to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

  12. Proportion of Older Adult Participants with Sero-response Greater Than or Equal to (>=) 4-fold (SRR-4) and 8-fold (SRR-8) Increase from Baseline in Neutralizing Antibody Titers for RSV-A, RSV-B, hMPV-A and hMPV-B

    Measured: Pre-injection baseline up to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

  13. GMFI of RSV Pre-fusion Protein (Pre-F) and hMPV Pre-F Serum Immunoglobulins G (IgG) Concentrations in Older Adults

    Measured: Pre-injection baseline up to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

  14. Geometric Mean Concentrations (GMC) of Serum IgG Versus RSV Pre-F and hMPV Pre-F in Older Adults

    Measured: Up to 1 month (Day 30), 6 months (Day 182), and 12 months (Day 364) after first IMP injection and 1 month (Day 394), 6 months (Day 546) and 12 months (Day 720) after second IMP injection (revaccination)

  15. Geometric Mean Ratios (GMRs) of Fold Increase of RSV-A and RSV-B Neutralizing Serum Antibody Titers Versus Fold Increase of RSV Pre-F Serum IgG Concentration in Older Adults

    Measured: Pre-injection baseline up to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

  16. GMR of Fold Increase of hMPV-A and hMPV-B Neutralizing Serum Antibody Titers Versus Fold Increase of hMPV Pre-F Serum IgG Concentration in Older Adults

    Measured: Pre-injection baseline up to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

Timeline

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

  1. First posted15 Aug 2024
  2. Study start13 Aug 2024
  3. Primary completion14 Feb 2025
  4. Study completionMay 2027 (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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Model description
Stage 1 is a sequential assignment followed by Stage 2 parallel assignment.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06556147
Sponsor's protocol ID
VXB241-001
Other IDs
VCA23394
Status last verified
May 2026
First submitted
13 Aug 2024
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Young A, Kolekar S, Mendoza CA, Jaberolansar N, Modhiran N, Webb T, McCuaig R, Kommajosyula V, Tardiota N, Dy Q, Amarilla AA, Dalrymple RL, Gillard M, Dutton JL, Magdalena J, Vandendriessche F, Smal J, Young PR, Watterson D, Hanon EJ, Chappell KJ. A second-generation molecular clamp stabilised bivalent candidate vaccine for protection against diseases caused by respiratory syncytial virus and human metapneumovirus. PLoS Pathog. 2025 Jul 17;21(7):e1013312. doi: 10.1371/journal.ppat.1013312. eCollection 2025 Jul.

    PubMed 40674411

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VXB-241 60 mcg (Low Dose), VXB-241 120 mcg (Medium Dose) and VXB-241 240 mcg (Medium-high Dose) in people with Healthy Volunteers, run by Sanofi at 4 sites in Australia.

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 7 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Older Adult Participants With 1 or More Unsolicited AEs (time frame: 1 month after first IMP injection (Days 1 to 30)). The study lists 4 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 NCT06556147, which also lists 1 linked publication.

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 20 May 2026.

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