NCT05903183

A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age

A Phase 2a Randomized, Observer-blind, Placebo-controlled, Dosage Optimization, Multi-center Clinical Trial to Evaluate the Safety and Immunogenicity of IVX-A12, a Respiratory Syncytial Virus and Human Metapneumovirus Bivalent Combination Virus-like Particle Protein Subunit Vaccine, in Adults 60 to 85 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Icosavax, Inc. · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of the study is to assess the safety, tolerability and immunogenicity of a bivalent respiratory syncytial virus (RSV)/human metapneumovirus (hMPV) virus-like particle (VLP) candidate vaccine (IVX-A12) compared to placebo, when administered as a single-dose regimen in healthy older adults 60 to 85 years of age.

Detailed description

The IVX-A12 Phase 2a clinical trial is a randomized, observer-blind, placebo-controlled, dosage optimization, multi-center trial to evaluate the safety and immunogenicity of a single intramuscular (IM) dose of IVX-A12, with or without adjuvant, in adults 60 to 85 years of age. Participants will be administered a single shot of IVX-A12, at specified dosage levels, or placebo. The overall duration of the study is up to 1 year (12 months). A subset of participants will be followed for an additional 12 months for a total duration of 24 months.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	IVX-A12	IVX-A12 without adjuvant
BIOLOGICAL	IVX-A12	IVX-A12 with adjuvant
BIOLOGICAL	Placebo	Diluent

Timeline

• Start date: 2023-05-15
• Primary completion: 2023-06-05
• Completion: 2024-10-25
• First posted: 2023-06-15
• Last updated: 2025-12-05
• Results posted: 2025-12-05

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study