Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults (NCT07295028) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults
Australia240 participantsStarted 2025-11-17
Plain-language summary
This study is being done to find out how safe and effective a new combined vaccine candidate, called VXB-251, is for older adults. The vaccine candidate is designed to protect against three common viruses that can cause respiratory tract infections:
* RSV (respiratory syncytial virus)
* hMPV (human metapneumovirus)
* PIV3 (parainfluenza virus type 3)
Two components of this vaccine (RSV and hMPV) have already been tested in people before, as part of another study for a two-in-one vaccine. However, this is the first time that the PIV3 component and all three components together (RSV, hMPV, and PIV3) are being tested in people.
The vaccine candidate will be given as a single intramuscular injection. The study will also test unlicensed comparator vaccines and a placebo (a substance that looks like the real vaccine but doesn't contain any active ingredients) that target none, one or two of these viruses to see whether combining all three components affects safety or how well the immune system responds.
Who can participate
Age range60 Years – 83 Years
SexALL
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Inclusion criteria
✓. Males and females aged 60 to 83 years of age at inclusion.
✓. Evidence of signed and dated participant informed consent form (PICF) prior to any study procedure, indicating that the subject 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 and childbearing/conception potential: only female participants with non-childbearing potential will be included. Male participants in a relationship with a female partner of childbearing potential must be willing to use a double contraceptive method together with their female partner for at least 4 weeks before and 12 weeks after the IMP injection at Visit 2 (day 1).
✕. Body mass index (BMI) ≥ 17.0 kg/m2 and ≤ 35.0 kg/m2.
✕. History of RSV, hMPV, and/or PIV3 infection affecting the participant and/or the participant's household in the previous 12 months.
What they're measuring
1
Proportion of Participants With 1 or More Unsolicited Adverse Events (AEs)
Timeframe: 1 month after IMP injection
2
Proportion of Participants With 1 or More Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and Premature Discontinuation Associated AEs (PDAEs)
Timeframe: 1 month after IMP injection
3
Proportion of Participants With 1 or More Solicited AEs
✕. Confirmed or suspected immunodeficiency, even if stable and well controlled.
✕. Ongoing severe asthma. Other allergic diseases (e.g., allergic rhinitis, atopic dermatitis / eczema, mild to moderate asthma, food allergies) are allowed at the investigator's or delegate's discretion.
✕. History of significant allergic reaction (e.g., anaphylaxis, hypersensitivity, angioedema) to medication or food or known allergy to vaccine, or any excipients in the formulation, and latex.