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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06556147




Registration number
NCT06556147
Ethics application status
Date submitted
13/08/2024
Date registered
15/08/2024

Titles & IDs
Public title
A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults
Scientific title
A Phase 1 Randomized, Placebo- and Active-controlled, Observer-blind Study in Older Adults with Run-in in Young Adults to Evaluate the Safety, Reactogenicity, and Immunogenicity of Four Dose Levels of VXB-241, a Molecular Clamp Stabilized Prefusion F Glycoprotein Subunit Bivalent Vaccine Candidate for the Prevention of Lower Respiratory Tract Disease Caused by Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
Secondary ID [1] 0 0
VXB241-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - VXB-241 60 mcg (Low Dose)
Treatment: Other - VXB-241 120 mcg (Medium Dose)
Treatment: Other - VXB-241 240 mcg (Medium-high Dose)
Treatment: Other - VXB-241 480 mcg (High Dose)
Treatment: Other - VXB-241
Other interventions - Placebo
Treatment: Other - Arexvy 120 mcg

Experimental: Stage 1, Day 1, Sequential Cohort 1 - Young and older adult participants will receive VXB-241 60 mcg (low dose) or Placebo, intramuscularly (IM), once on Day 1.

Experimental: Stage 1, Day 1, Sequential Cohort 2 - Young and older adult participants will receive VXB-241 120 mcg (medium dose) or Placebo, IM, once on Day 1.

Experimental: Stage 1, Day 1, Sequential Cohort 3 - Young and older adult participants will receive VXB-241 240 mcg (medium-high dose) or Placebo, IM, once on Day 1.

Experimental: Stage 1, Day 1, Sequential Cohort 4 - Young and older adult participants will receive VXB-241 480 mcg (high dose) or Placebo, IM, once on Day 1.

Experimental: Stage 2, Day 1, Concurrent Group 1a - Older adult participants will receive VXB-241 60 mcg (low dose), IM, once on Day 1.

Experimental: Stage 2, Day 1, Concurrent Group 1b - Older adult participants will receive VXB-241 120 mcg (medium dose), IM, once on Day 1.

Experimental: Stage 2, Day 1, Concurrent Group 1c - Older adult participants will receive VXB-241 240 mcg (medium-high dose), IM, once on Day 1.

Experimental: Stage 2, Day 1, Concurrent Group 1d - Older adult participants will receive VXB-241 480 mcg (high dose), IM, once on Day 1.

Active comparator: Stage 2, Day 1, Concurrent Group 2a - Older adult participants will receive Arexvy 120 mcg, IM, once on Day 1.

Placebo comparator: Stage 2, Day 1, Concurrent Group 3a - Older adult participants will receive Placebo, IM, once on Day 1.

Experimental: Group 1e: VXB-241 Revaccination in VXB-241 Recipients - Approximately 50% of the older adult participants who received VXB-241 (any dose level), will receive VXB-241, IM, once on Day 364 in the second year of the study.

Placebo comparator: Group 1f: Placebo Revaccination in VXB-241 Recipients - Approximately 50% of the older adult participants who received VXB-241 (any dose level), will receive Placebo, IM, once on Day 364 in the second year of the study.

Active comparator: Group 2b: Arexvy Revaccination - All older adult participants who received Arexvy 120 mcg will receive Arexvy 120 mcg revaccination, IM, once on Day 364 in the second year of the study.

Experimental: Group 3b: VXB-241 - All older adult participants who received Placebo will receive VXB-241, IM, once on Day 364 in the second year of the study.


Treatment: Other: VXB-241 60 mcg (Low Dose)
VXB-241 low dose, single, IM injection.

Treatment: Other: VXB-241 120 mcg (Medium Dose)
VXB-241 medium dose, single, IM injection.

Treatment: Other: VXB-241 240 mcg (Medium-high Dose)
VXB-241 medium-high dose, single, IM injection.

Treatment: Other: VXB-241 480 mcg (High Dose)
VXB-241 high dose, single, IM injection.

Treatment: Other: VXB-241
VXB-241 dose to be decided based on Year-1 results, single, IM injection.

Other interventions: Placebo
Placebo, single, IM injection.

Treatment: Other: Arexvy 120 mcg
Arexvy 120 mcg, single, IM injection.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Older Adult Participants With 1 or More Unsolicited AEs
Timepoint [1] 0 0
1 month after first IMP injection (Days 1 to 30)
Primary outcome [2] 0 0
Proportion of Older Adult Participants With 1 or More Solicited AEs
Timepoint [2] 0 0
7 days after first IMP injection (Days 1 to 8)
Primary outcome [3] 0 0
Geometric Mean Fold Increase (GMFI) of RSV-A, RSV-B, hMPV-A, and hMPV-B Serum Neutralizing Antibody Titers in Older Adults
Timepoint [3] 0 0
Pre-injection baseline to 1 month (Day 30) after first IMP injection
Primary outcome [4] 0 0
Ratio of Dose-response Curves for GMFIs of RSV-A, RSV-B, hMPV-A and hMPV-B Serum Neutralizing Antibody Titers in Older Adults
Timepoint [4] 0 0
Pre-injection baseline to 1 month (Day 30) after first IMP injection
Secondary outcome [1] 0 0
Proportion of Older Adult Participants With 1 or More Unsolicited AEs and With 1 or More Severe Unsolicited AE
Timepoint [1] 0 0
1 month after first IMP injection (Days 1 to 30) and 1 month after second IMP injection (revaccination, Days 364 to 394)
Secondary outcome [2] 0 0
Proportion of Older Adult Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and Premature Discontinuation Associated AEs (PDAEs)
Timepoint [2] 0 0
1 month after first IMP injection (Days 1 to 30) and 1 month after second IMP injection (revaccination, Days 364 to394), and throughout follow-up (Days 1 to 720)
Secondary outcome [3] 0 0
Mean Change From Baseline for Abnormal and Severe Abnormal Hematology Laboratory Values for Hemoglobin in Older Adults
Timepoint [3] 0 0
7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination
Secondary outcome [4] 0 0
Mean Change From Baseline for Abnormal and Severe Abnormal Hematology Laboratory Values for Red Blood Cells, White Blood Cells, and Platelet Count in Older Adults
Timepoint [4] 0 0
7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination
Secondary outcome [5] 0 0
Mean Change From Baseline for Abnormal and Severe Abnormal Blood Chemistry Laboratory Values for Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Alkaline Phosphatase in Older Adults
Timepoint [5] 0 0
7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination
Secondary outcome [6] 0 0
Mean Change From Baseline for Abnormal and Severe Abnormal Blood Chemistry Laboratory Values for Total Bilirubin, Creatinine, and Urea in Older Adults
Timepoint [6] 0 0
7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination
Secondary outcome [7] 0 0
Proportion of Older Adult With Abnormal and Severe Abnormal Values for Hematology Laboratory Parameter
Timepoint [7] 0 0
7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination)
Secondary outcome [8] 0 0
Proportion of Older Adult With Abnormal Values and Severe Abnormal Values for Blood Chemistry Laboratory Parameter
Timepoint [8] 0 0
7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination)
Secondary outcome [9] 0 0
Proportion of Older Adult Participants With Solicited AEs
Timepoint [9] 0 0
7 days after 2nd IMP injection (revaccination, Day 364 to 371)
Secondary outcome [10] 0 0
GMFI of RSV-A, RSV-B, hMPV-A, and hMPV-B Serum Neutralizing Antibody Titers in Older Adults
Timepoint [10] 0 0
Pre-injection baseline to 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)
Secondary outcome [11] 0 0
Geometric Mean Titers (GMTs) of RSV-A, RSV-B, hMPV-A, and hMPV-B Serum Neutralizing Antibody Titers in Older Adults
Timepoint [11] 0 0
Pre-injection baseline to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)
Secondary outcome [12] 0 0
Proportion of Older Adult Participants with Sero-response Greater Than or Equal to (>=) 4-fold (SSR-4) and 8-fold (SSR-8) Increase from Baseline in Neutralizing Antibody Titers for RSV-A, RSV-B, hMPV-A and hMPV-B
Timepoint [12] 0 0
Pre-injection baseline to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)
Secondary outcome [13] 0 0
GMFI of RSV Pre-fusion Protein (Pre-F) and hMPV Pre-F Serum Immunoglobulins G (IgG) Concentrations in Older Adults
Timepoint [13] 0 0
Pre-injection baseline to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)
Secondary outcome [14] 0 0
Geometric Mean Concentrations (GMC) of Serum IgG Versus RSV Pre-F and hMPV Pre-F in Older Adults
Timepoint [14] 0 0
1 month (Day 30), 6 months (Day 182), and 12 months (Day 364) after first IMP injection and 1 month (Day 394), 6 months (Day 546) and 12 months (Day 720) after second IMP injection (revaccination)
Secondary outcome [15] 0 0
Geometric Mean Ratios (GMRs) of Fold Increase of RSV-A and RSV-B Neutralizing Serum Antibody Titers Versus Fold Increase of RSV Pre-F Serum IgG Concentration in Older Adults
Timepoint [15] 0 0
Pre-injection baseline to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)
Secondary outcome [16] 0 0
GMR of Fold Increase of hMPV-A and hMPV-B Neutralizing Serum Antibody Titers Versus Fold Increase of hMPV Pre-F Serum IgG Concentration in Older Adults
Timepoint [16] 0 0
Pre-injection baseline to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

Eligibility
Key inclusion criteria
1. Male or female, 18 to 40 years of age (yoa) (young adult) or 60 to 83 yoa (older adult).
2. 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.
3. Willingness and ability to comply with the planned study visits and calls, procedures, and restrictions for the duration of the study.
4. 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.
5. Non-smoker or occasional smoker, defined as smoking less than 10 nicotine-containing cigarettes/ vapes/cigars/pipe fills per week.
6. 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).
7. Body Mass Index (BMI) >=17.0 kilogram per square meter (kg/m^2) and less than or equal to (<=) 35.0 kg/m^2.
Minimum age
18 Years
Maximum age
83 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of RSV and/or hMPV infection affecting the participant and/or the participant's household in the previous 12 months.
2. 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.
3. Confirmed or suspected immunodeficiency, even if stable and well controlled.
4. 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).
5. History of severe allergic reaction (example, anaphylaxis) to any substance, including vaccine components and latex.
6. History of severe adverse event (AEs) associated with vaccine administration.
7. Ongoing disorders of coagulation, which contraindicate IM injections.
8. 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.
9. 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.
10. 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.
11. Disease expected to prevent completion of the study (that is to rapidly deteriorate within the timeframe of the study).
12. Prior treatments.

1. Licensed RSV vaccine or investigational RSV and/or hMPV vaccine received at any time.
2. 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. Immunoglobulins G (IgGs) or any blood product received in the previous 3 months.
5. 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.
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 and/or positive alcohol breath test.
15. 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).
16. Intention to participate in any investigational drug/vaccine 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. Limited to premenopausal female participants: breastfeeding, positive pregnancy test or intention to become pregnant during the first 3 months of the study.
20. Any other reason which would prevent the participant from participating in the study or interfere with the participant's compliance with study procedures.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
136
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of the Sunshine Coast - Morayfield
Recruitment hospital [2] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [3] 0 0
University of the Sunshine Coast - South Brisbane
Recruitment postcode(s) [1] 0 0
4506 - Morayfield
Recruitment postcode(s) [2] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vicebio Australia Proprietary Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Nischal Sahai
Address 0 0
University of the Sunshine Coast
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Giovanni Della Cioppa
Address 0 0
Country 0 0
Phone 0 0
+393285554119
Fax 0 0
Email 0 0
giovanni@vicebio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06556147