A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults
NCT06556147 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2026-05-20
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.
Conditions
- Healthy Volunteers
Interventions
- BIOLOGICAL
-
VXB-241 60 mcg (Low Dose)
VXB-241 low dose, single, IM injection.
- BIOLOGICAL
-
VXB-241 120 mcg (Medium Dose)
VXB-241 medium dose, single, IM injection.
- BIOLOGICAL
-
VXB-241 240 mcg (Medium-high Dose)
VXB-241 medium-high dose, single, IM injection.
- BIOLOGICAL
-
VXB-241 480 mcg (High Dose)
VXB-241 high dose, single, IM injection.
- BIOLOGICAL
-
VXB-241 240 mcg
VXB-241 240 mcg (RSV preF 120 mcg + hMPV preF 120 mcg) (based on 1 month post 1st IMP injection results) single, IM injection.
- OTHER
-
Placebo
Placebo, single, IM injection.
- BIOLOGICAL
-
Arexvy 120 mcg
Arexvy 120 mcg, single, IM injection.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 83 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-08-13
- Primary Completion
- 2025-02-14
- Completion
- 2027-05-31
Countries
- Australia
Study Locations
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