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ACTIVE NOT RECRUITING
NCT06556147
PHASE1

A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults

Sponsor: Vicebio Australia Proprietary Limited

View on ClinicalTrials.gov

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.

Official 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)

Key Details

Gender

All

Age Range

18 Years - 83 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2024-08-13

Completion Date

2027-05

Last Updated

2025-10-01

Healthy Volunteers

Yes

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.

Locations (4)

University of the Sunshine Coast

Morayfield, Queensland, Australia

University of the Sunshine Coast

Sippy Downs, Queensland, Australia

University of the Sunshine Coast

South Brisbane, Queensland, Australia

Veritus Research

Bayswater, Victoria, Australia