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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 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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have previously received an experimental vaccine for respiratory syncytial virus (RSV) or human metapneumovirus (hMPV).You have a serious heart or lung condition that makes you more likely to have severe respiratory syncytial virus (RSV) or human metapneumovirus (hMPV) disease.You are currently sick, with or without a fever, when you are supposed to get the vaccine.Older adults who have health problems that affect their physical, mental, or cognitive abilities, as determined by the study site.You have had severe reactions to vaccines in the past, like anaphylaxis or Guillain-Barré syndrome. You are also allergic to any ingredient in the IVX-121 and/or IVX-241 vaccine, or you have a latex allergy.
Research Study Groups:
This trial has the following groups:- Group 1: IVX-A12 Vaccine - Medium Dosage Level
- Group 2: IVX-A12 Vaccine - Low Dosage Level
- Group 3: IVX-A12 Vaccine + MF59® - Medium Dosage Level
- Group 4: IVX-A12 Vaccine + MF59® - Low Dosage Level
- Group 5: IVX-A12 Vaccine - High Dosage Level
- Group 6: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.