A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults
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)
2 other identifiers
interventional
144
1 country
4
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) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Aug 2024
Longer than P75 for phase_1 healthy-volunteers
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2024
CompletedStudy Start
First participant enrolled
August 13, 2024
CompletedFirst Posted
Study publicly available on registry
August 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
ExpectedMay 20, 2026
May 1, 2026
6 months
August 13, 2024
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Proportion of Older Adult Participants With 1 or More Unsolicited AEs
1 month after first IMP injection (Days 1 to 30)
Proportion of Older Adult Participants With 1 or More Solicited AEs
7 days after first IMP injection (Days 1 to 8)
Geometric Mean Fold Increase (GMFI) of RSV-A, RSV-B, hMPV-A, and hMPV-B Serum Neutralizing Antibody Titers in Older Adults
GMFI is defined as geometric mean of ratios of specific antibody titer/concentration at each post-vaccination time point over pre-vaccination baseline.
Pre-injection baseline to 1 month (Day 30) after first IMP injection
Ratio of Dose-response Curves for GMFIs of RSV-A, RSV-B, hMPV-A and hMPV-B Serum Neutralizing Antibody Titers in Older Adults
Ratio of VXB-241 dose versus GMFI of RSV-A, RSV-B, hMPV-A and hMPV-B will be calculated.
Pre-injection baseline to 1 month (Day 30) after first IMP injection
Secondary Outcomes (16)
Proportion of Older Adult Participants With 1 or More Unsolicited AEs and With 1 or More Severe Unsolicited AE
1 month after first IMP injection (Days 1 to 30) and 1 month after second IMP injection (revaccination, Days 364 to 394)
Proportion of Older Adult Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and Premature Discontinuation Associated AEs (PDAEs)
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)
Mean Change From Baseline for Abnormal and Severe Abnormal Hematology Laboratory Values for Hemoglobin in Older Adults
7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination
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
7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination
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
7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination
- +11 more secondary outcomes
Study Arms (14)
Stage 1, Day 1, Sequential Cohort 1
EXPERIMENTALYounger and older adult participants will receive VXB-241 60 mcg (low dose) or Placebo, intramuscularly (IM), once on Day 1.
Stage 1, Day 1, Sequential Cohort 2
EXPERIMENTALYounger and older adult participants will receive VXB-241 120 mcg (medium dose) or Placebo, IM, once on Day 1.
Stage 1, Day 1, Sequential Cohort 3
EXPERIMENTALYounger and older adult participants will receive VXB-241 240 mcg (medium-high dose) or Placebo, IM, once on Day 1.
Stage 1, Day 1, Sequential Cohort 4
EXPERIMENTALYounger and older adult participants will receive VXB-241 480 mcg (high dose) or Placebo, IM, once on Day 1.
Stage 2, Day 1, Concurrent Group 1a
EXPERIMENTALOlder adult participants will receive VXB-241 60 mcg (low dose), IM, once on Day 1.
Stage 2, Day 1, Concurrent Group 1b
EXPERIMENTALOlder adult participants will receive VXB-241 120 mcg (medium dose), IM, once on Day 1.
Stage 2, Day 1, Concurrent Group 1c
EXPERIMENTALOlder adult participants will receive VXB-241 240 mcg (medium-high dose), IM, once on Day 1.
Stage 2, Day 1, Concurrent Group 1d
EXPERIMENTALOlder adult participants will receive VXB-241 480 mcg (high dose), IM, once on Day 1.
Stage 2, Day 1, Concurrent Group 2a
ACTIVE COMPARATOROlder adult participants will receive Arexvy 120 mcg, IM, once on Day 1.
Stage 2, Day 1, Concurrent Group 3a
PLACEBO COMPARATOROlder adult participants will receive Placebo, IM, once on Day 1.
Group 1e: VXB-241 Revaccination in VXB-241 Recipients
EXPERIMENTALApproximately 50% of the older adult participants who received VXB-241 240 mcg, will receive VXB-241 240 mcg, IM, (based on 1 month post 1st IMP injection results), once on Day 364 in the second year of the study.
Group 1f: Placebo Revaccination in VXB-241 Recipients
PLACEBO COMPARATORApproximately 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.
Group 2b: Placebo Arexvy Revaccination
PLACEBO COMPARATORAll older adult participants who received Arexvy 120 mcg will receive Placebo revaccination, IM, once on Day 364 in the second year of the study.
Group 3b: VXB-241
EXPERIMENTALAll older adult participants who received Placebo will receive VXB-241 240 mcg (based on 1 month post 1st IMP injection results), IM, once on Day 364 in the second year of the study.
Interventions
VXB-241 low dose, single, IM injection.
VXB-241 medium dose, single, IM injection.
VXB-241 medium-high dose, single, IM injection.
VXB-241 high dose, single, IM injection.
VXB-241 240 mcg (RSV preF 120 mcg + hMPV preF 120 mcg) (based on 1 month post 1st IMP injection results) single, IM injection.
Placebo, single, IM injection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (4)
University of the Sunshine Coast
Morayfield, Queensland, 4506, Australia
University of the Sunshine Coast
Sippy Downs, Queensland, 4556, Australia
University of the Sunshine Coast
South Brisbane, Queensland, 4101, Australia
Veritus Research
Bayswater, Victoria, 3153, Australia
Related Publications (1)
Young A, Kolekar S, Mendoza CA, Jaberolansar N, Modhiran N, Webb T, McCuaig R, Kommajosyula V, Tardiota N, Dy Q, Amarilla AA, Dalrymple RL, Gillard M, Dutton JL, Magdalena J, Vandendriessche F, Smal J, Young PR, Watterson D, Hanon EJ, Chappell KJ. A second-generation molecular clamp stabilised bivalent candidate vaccine for protection against diseases caused by respiratory syncytial virus and human metapneumovirus. PLoS Pathog. 2025 Jul 17;21(7):e1013312. doi: 10.1371/journal.ppat.1013312. eCollection 2025 Jul.
PMID: 40674411DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2024
First Posted
August 15, 2024
Study Start
August 13, 2024
Primary Completion
February 14, 2025
Study Completion (Estimated)
May 1, 2027
Last Updated
May 20, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share