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 range18 Years – 83 Years
SexALL
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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).
✕. 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.
✕. 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.