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About
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:
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.
Full description
This is a multicenter randomized, placebo- and comparator-controlled, dose-ranging study to be conducted in Australia in older adults, aged 60 to 83 years, to evaluate the safety, reactogenicity, and immunogenicity of a trivalent RSV/hMPV/PIV3 vaccine candidate, VXB-251. All investigational medicinal products (IMPs) will be administered as a single 0.5 mL intramuscular injection on day 1.
Recruitment will be in 2 stages:
Stage 1 (N=10). Two cohorts, each of 5 participants, will be sequentially enrolled at a 4:1 ratio to receive:
At each enrolling site, at least 1 hour must elapse between IMP injection in the first sentinel and next IMP injection to monitor for hypersensitivity reactions and other fast-onset adverse events (AEs). The investigator or delegate will decide if and when the next sentinel can be vaccinated.
A Safety Monitoring Committee (SMC) will make recommendations on escalation from 1 sequential cohort to the next and progress from Stage 1 to Stage 2 based on 1-week safety and reactogenicity available data from the prior cohort.
Stage 2 (N=230). Participants will be concurrently assigned on day 1 (Visit 2) at an unequal ratio into 1 of 8 study groups and receive one of the following:
In Stage 1, the study will be open-label across cohorts and observer-blind within each cohort. In Stage 2, the study will be observer-blind.
The study duration for each participant will be 1 year.
Enrollment
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Inclusion criteria
Exclusion criteria
History of RSV, hMPV, and/or PIV3 infection affecting the participant and/or the participant's household in the previous 12 months.
History of autoimmune disease (AID) or possibly 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 (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.
History of severe AE associated with vaccine administration.
Ongoing disorders of coagulation, which contraindicate IM injections.
Donation or loss of ≥ 500 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 indicating ongoing HIV, HBV and/or HCV infection, and/or documented ongoing HIV, HBV, or HCV infection.
Other poorly controlled and/or impactful chronic disease. A disease is defined as poorly controlled if it requires meaningful change in therapy and/or unplanned medical visit(s) in the previous 3 months. A disease is defined as impactful if, in the investigator's judgment, it meaningfully affects the participant's ability to manage self-care and/or activities of daily living.
Disease expected to prevent completion of the study (i.e. to rapidly deteriorate within the timeframe of the study).
Prior treatments.
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 determined at the investigator's discretion.
History of recreational drug abuse in the previous year and/or positive test for drugs of abuse at Visit 2 (day 1), unless there is an explanation acceptable to the investigator (e.g., 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/medical device 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.
Any other reason which would prevent the participant from participating in the study or interfere with the participant's compliance with study procedures.
Primary purpose
Allocation
Interventional model
Masking
240 participants in 8 patient groups, including a placebo group
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Central trial contact
Julie Dutton
Data sourced from clinicaltrials.gov
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