New combo vaccine aims to shield seniors from RSV and HMPV
NCT ID NCT06556147
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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144 people
The number who actually took part.
- Started
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Aug 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 83 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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University of the Sunshine Coast
Morayfield, Queensland, 4506, Australia
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University of the Sunshine Coast
Sippy Downs, Queensland, 4556, Australia
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University of the Sunshine Coast
South Brisbane, Queensland, 4101, Australia
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Veritus Research
Bayswater, Victoria, 3153, Australia
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