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New combo vaccine aims to shield seniors from RSV and HMPV

NCT ID NCT06556147

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new vaccine called VXB-241 in healthy adults aged 60-83, with a smaller group of younger adults (18-40) first. The vaccine is designed to protect against two viruses that can cause serious lung infections: RSV and HMPV. Researchers will check how safe the vaccine is and how well it boosts the immune system, using four different dose levels. Some participants will get a booster shot about a year later to see if revaccination is helpful.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

144 people

The number who actually took part.

Started

Aug 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 83 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, 18 to 40 years of age (yoa) (younger adult) or 60 to 83 yoa (older adult). 2. 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. 3. Willingness and ability to comply with the planned study visits and calls, procedures, and restrictions for the duration of the study. 4. 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. 5. Non-smoker or occasional smoker, defined as smoking less than 10 nicotine-containing cigarettes/ vapes/cigars/pipe fills per week. 6. 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). 7. Body Mass Index (BMI) \>=17.0 kilogram per square meter (kg/m\^2) and less than or equal to (\<=) 35.0 kg/m\^2. Exclusion Criteria: 1. History of RSV and/or hMPV infection affecting the participant and/or the participant's household in the previous 12 months. 2. 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. 3. Confirmed or suspected immunodeficiency, even if stable and well controlled. 4. 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). 5. History of severe allergic reaction (example, anaphylaxis) to any substance, including vaccine components and latex. 6. History of severe adverse event (AEs) associated with vaccine administration. 7. Ongoing disorders of coagulation, which contraindicate IM injections. 8. 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. 9. 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. 10. 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. 11. Disease expected to prevent completion of the study (that is to rapidly deteriorate within the timeframe of the study). 12. Prior treatments. 1. Licensed RSV vaccine or investigational RSV and/or hMPV vaccine received at any time. 2. Investigational drug or vaccine received in the previous 6 months. 3. Chemotherapy, radiotherapy, and/or other immunosuppressive medication including biologics received in the previous 6 months. 4. Immunoglobulins G (IgGs) or any blood product received in the previous 3 months. 5. 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. 13. 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. 14. History of alcohol abuse in the previous year and/or positive alcohol breath test. 15. 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). 16. Intention to participate in any investigational drug/vaccine clinical trial at any time throughout the planned duration of this study. 17. 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. 18. Intention to move to a location that would prevent participating in the study until study end. 19. Limited to premenopausal female participants: breastfeeding, positive pregnancy test or intention to become pregnant during the first 3 months of the study. 20. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of the Sunshine Coast

    Morayfield, Queensland, 4506, Australia

  • University of the Sunshine Coast

    Sippy Downs, Queensland, 4556, Australia

  • University of the Sunshine Coast

    South Brisbane, Queensland, 4101, Australia

  • Veritus Research

    Bayswater, Victoria, 3153, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.