Status:
ACTIVE_NOT_RECRUITING
A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults
Lead Sponsor:
Vicebio Australia Proprietary Limited
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-83 years
Phase:
PHASE1
Brief 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...
Detailed Description
This is a multi-center study in older adults with run-in in younger adults to evaluate the safety, reactogenicity, and immunogenicity of 4 dose levels of VXB-241. The total planned sample size is 136 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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.
Exclusion
- 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.
- History of severe adverse event (AEs) associated with vaccine administration.
- Ongoing disorders of coagulation, which contraindicate IM injections.
- 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.
- 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.
- 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.
- Disease expected to prevent completion of the study (that is to rapidly deteriorate within the timeframe of the study).
- Prior treatments.
- Licensed RSV vaccine or investigational RSV and/or hMPV vaccine received at any time.
- Investigational drug or vaccine received in the previous 6 months.
- Chemotherapy, radiotherapy, and/or other immunosuppressive medication including biologics received in the previous 6 months.
- Immunoglobulins G (IgGs) or any blood product received in the previous 3 months.
- 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.
- 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.
- History of alcohol abuse in the previous year and/or positive alcohol breath test.
- 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).
- Intention to participate in any investigational drug/vaccine clinical trial at any time throughout the planned duration of this study.
- 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.
- Intention to move to a location that would prevent participating in the study until study end.
- Limited to premenopausal female participants: breastfeeding, positive pregnancy test or intention to become pregnant during the first 3 months of the study.
- Any other reason which would prevent the participant from participating in the study or interfere with the participant's compliance with study procedures.
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2027
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06556147
Start Date
August 13 2024
End Date
May 1 2027
Last Update
October 1 2025
Active Locations (4)
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1
University of the Sunshine Coast
Morayfield, Queensland, Australia, 4506
2
University of the Sunshine Coast
Sippy Downs, Queensland, Australia, 4556
3
University of the Sunshine Coast
South Brisbane, Queensland, Australia, 4101
4
Veritus Research
Bayswater, Victoria, Australia, 3153