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Virus Therapy

IVX-A12 for Healthy Older Adults

Phase 1
Waitlist Available
Research Sponsored by Icosavax, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 0 up to day 180

Summary

This trial is testing a new vaccine called IVX-A12, which aims to protect older adults aged 60 to 75 from two respiratory viruses, RSV and hMPV. The vaccine works by using harmless particles that mimic the viruses, helping the immune system learn to fight them.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 0 up to day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 0 up to day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Participants With RSV and hMPV Immunoglobulin G (IgG) Prefusion F Protein-specific Antibody Titers
Secondary study objectives
GMFR in Serum for RSV and hMPV IgG Prefusion F Protein-specific Antibody Titers
Geometric Fold Rise (GMFR) in Serum for Anti-RSV/A, RSV/B, hMPV/A and hMPV/B Specific NAb

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: IVX-A12 Vaccine - Medium Dosage LevelExperimental Treatment2 Interventions
Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
Group II: IVX-A12 Vaccine - Low Dosage LevelExperimental Treatment2 Interventions
Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 virus-like particles \[VLPs\]), administered intramuscularly (IM) once on Day 0.
Group III: IVX-A12 Vaccine - High Dosage LevelExperimental Treatment2 Interventions
Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
Group IV: IVX-A12 Vaccine + MF59® - Medium Dosage LevelExperimental Treatment3 Interventions
Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
Group V: IVX-A12 Vaccine + MF59® - Low Dosage LevelExperimental Treatment3 Interventions
Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
Group VI: PlaceboPlacebo Group1 Intervention
Participants will receive placebo, administered IM once on Day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IVX-121
2022
Completed Phase 1
~140
IVX-241
2022
Completed Phase 1
~140

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Icosavax, Inc.Lead Sponsor
2 Previous Clinical Trials
407 Total Patients Enrolled

Media Library

IVX-A12 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05664334 — Phase 1
Healthy Subjects Research Study Groups: IVX-A12 Vaccine - Medium Dosage Level, IVX-A12 Vaccine - Low Dosage Level, IVX-A12 Vaccine + MF59® - Medium Dosage Level, IVX-A12 Vaccine + MF59® - Low Dosage Level, IVX-A12 Vaccine - High Dosage Level, Placebo
Healthy Subjects Clinical Trial 2023: IVX-A12 Highlights & Side Effects. Trial Name: NCT05664334 — Phase 1
IVX-A12 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05664334 — Phase 1
~44 spots leftby Dec 2025