A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults (NCT06556147) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults
Australia144 participantsStarted 2024-08-13
Plain-language 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 assess the impact of revaccination approximately 1 year later.
Who can participate
Age range
18 Years – 83 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Older Adult Participants With 1 or More Unsolicited AEs
Timeframe: 1 month after first IMP injection (Days 1 to 30)
2
Proportion of Older Adult Participants With 1 or More Solicited AEs
Timeframe: 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
Timeframe: 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
Timeframe: Pre-injection baseline to 1 month (Day 30) after first IMP injection
. Body Mass Index (BMI) \>=17.0 kilogram per square meter (kg/m\^2) and less than or equal to (\<=) 35.0 kg/m\^2.
. 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.