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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 0 up to day 180

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