Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-17

Study Completion Date

2027-04-24

Brief Summary

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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.

Detailed Description

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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:

* Cohort 1: either a medium dose of the vaccine candidate or the placebo control,
* Cohort 2: either a high dose of the vaccine candidate or the placebo control

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:

* VXB-251 trivalent (RSV/hMPV/PIV3) vaccine candidate, low dose (N=30)
* VXB-251 trivalent (RSV/hMPV/PIV3) vaccine candidate, medium dose (N=26)
* VXB-251 trivalent (RSV/hMPV/PIV3) vaccine candidate, high dose (N=26)
* VXB-241 bivalent (RSV/hMPV) unlicensed comparator (N=30)
* VXB-213 monovalent (RSV) unlicensed comparator (N=30)
* VXB-221 monovalent (hMPV) unlicensed comparator (N=30).
* VXB-232 monovalent (PIV3) unlicensed comparator (N=30)
* Placebo (N=28)

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.

Conditions

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Lower Respiratory Tract Disease Healthy Participants

Keywords

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RSV hMPV PIV3 Multipathogen respiratory virus vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stage 1 is a sequential assignment followed by Stage 2 parallel assignment.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Double

Study Groups

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VXB-251, low dose

Group Type EXPERIMENTAL

trivalent (RSV/hMPV/PIV3) vaccine candidate

Intervention Type BIOLOGICAL

VXB-251 low dose, single, IM injection.

VXB-251, medium dose

Group Type EXPERIMENTAL

trivalent (RSV/hMPV/PIV3) vaccine candidate

Intervention Type BIOLOGICAL

VXB-251 medium dose, single, IM injection.

VXB-251, high dose

Group Type EXPERIMENTAL

trivalent (RSV/hMPV/PIV3) vaccine candidate

Intervention Type BIOLOGICAL

VXB-251 high dose, single, IM injection.

VXB-241

Group Type EXPERIMENTAL

bivalent (RSV/hMPV) unlicensed comparator

Intervention Type BIOLOGICAL

VXB-241 medium dose, single, IM injection.

VXB-213

Group Type EXPERIMENTAL

monovalent (RSV) unlicensed comparator

Intervention Type BIOLOGICAL

VXB-213 medium dose, single, IM injection.

VXB-221

Group Type EXPERIMENTAL

Biological/Vaccine: monovalent (hMPV) unlicensed comparator

Intervention Type BIOLOGICAL

VXB-221 medium dose, single, IM injection.

VXB-232

Group Type EXPERIMENTAL

monovalent (PIV3) unlicensed comparator

Intervention Type BIOLOGICAL

VXB-232 medium dose, single, IM injection.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

diluent, single, IM injection.

Interventions

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trivalent (RSV/hMPV/PIV3) vaccine candidate

VXB-251 low dose, single, IM injection.

Intervention Type BIOLOGICAL

trivalent (RSV/hMPV/PIV3) vaccine candidate

VXB-251 medium dose, single, IM injection.

Intervention Type BIOLOGICAL

trivalent (RSV/hMPV/PIV3) vaccine candidate

VXB-251 high dose, single, IM injection.

Intervention Type BIOLOGICAL

bivalent (RSV/hMPV) unlicensed comparator

VXB-241 medium dose, single, IM injection.

Intervention Type BIOLOGICAL

monovalent (RSV) unlicensed comparator

VXB-213 medium dose, single, IM injection.

Intervention Type BIOLOGICAL

Biological/Vaccine: monovalent (hMPV) unlicensed comparator

VXB-221 medium dose, single, IM injection.

Intervention Type BIOLOGICAL

monovalent (PIV3) unlicensed comparator

VXB-232 medium dose, single, IM injection.

Intervention Type BIOLOGICAL

Placebo

diluent, single, IM injection.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Males and females aged 60 to 83 years of age at inclusion.
2. 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.
3. Willingness and ability to comply with the planned study visits and calls, procedures, and restrictions for the duration of the study.

Exclusion Criteria

5. Non-smoker or occasional smoker, defined as smoking less than 10 nicotine-containing cigarettes/ vapes/cigars/pipe fills per week.
6. 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).
7. Body mass index (BMI) ≥ 17.0 kg/m2 and ≤ 35.0 kg/m2.

1. History of RSV, hMPV, and/or PIV3 infection affecting the participant and/or the participant's household in the previous 12 months.
2. 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.
3. Confirmed or suspected immunodeficiency, even if stable and well controlled.
4. 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.
5. 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.
6. History of severe AE associated with vaccine administration.
7. Ongoing disorders of coagulation, which contraindicate IM injections.
8. 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.
9. Positive serum test results indicating ongoing HIV, HBV and/or HCV infection, and/or documented ongoing HIV, HBV, or HCV infection.
10. 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.
11. Disease expected to prevent completion of the study (i.e. to rapidly deteriorate within the timeframe of the study).
12. Prior treatments.

1. Receipt of licensed RSV vaccine and/or enrollment in clinical trials(s) evaluating investigational RSV, hMPV, PIV3, and/or molecular clamp-based vaccine candidates at any time, unless it was documented that the participant received a placebo.
2. Other investigational drug or vaccine received in the previous 6 months.
3. Chemotherapy, radiotherapy, and/or other immunosuppressive medication (including biologics) received in the previous 6 months.
4. IgGs or any blood product received in the previous 3 months.
5. Systemic corticosteroids (oral/intravenous/IM) at doses equivalent to ≥ 20 mg prednisone per day 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.
6. Received or plan to receive licensed non-live vaccine(s) for the period starting 2 weeks before to 4 weeks after of the study IMP injection or licensed live vaccine(s) for the period starting from 4 weeks before to 4 weeks after the study IMP injection. Pandemic or emergency vaccines are always allowed as per country guidelines.
13. 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.
14. History of alcohol abuse in the previous year determined at the investigator's discretion.
15. 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).
16. Intention to participate in any investigational drug/vaccine/medical device clinical trial at any time throughout the planned duration of this study.
17. 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.
18. Intention to move to a location that would prevent participating in the study until study end.
19. Any other reason which would prevent the participant from participating in the study or interfere with the participant's compliance with study procedures.

Minimum Eligible Age

60 Years

Maximum Eligible Age

83 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nischal Sahai, MD

Role: PRINCIPAL_INVESTIGATOR

University of the Sunshine Coast, South Bank

Stephanie Wallace, MD

Role: PRINCIPAL_INVESTIGATOR

University of the Sunshine Coast, Sippy Downs

Christopher Moller, MD

Role: PRINCIPAL_INVESTIGATOR

University of the Sunshine Coast, Morayfield

Rebecca Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

Veritus Research

Madeleine Janin, MD

Role: PRINCIPAL_INVESTIGATOR

Momentum Clinical Research

Rishi Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Emeritus Research

Locations

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University of Sunshine Coast, South Bank

Brisbane, , Australia

Site Status RECRUITING