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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 at days 0, 7, 180, and 365
Awards & highlights

Study Summary

This trial tests a single-dose RSV/hMPV vaccine in healthy older adults, to see if it is safe and effective.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at days 0, 7, 180, and 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and at days 0, 7, 180, and 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants With RSV and hMPV Immunoglobulin G (IgG) Prefusion F Protein-specific Antibody Titers
Proportion of Participants With RSV/A, RSV/B, hMPV/A and hMPV/B Neutralizing Antibodies (NAb)
Proportion of Participants With Solicited Local Reactions and Systemic AEs
+1 more
Secondary outcome measures
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
Proportion of Participants With Clinically Significant Safety Laboratory Abnormalities
+2 more

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
1 Previous Clinical Trials
264 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 - High Dosage Level, IVX-A12 Vaccine - Low Dosage Level, IVX-A12 Vaccine + MF59® - Low Dosage Level, IVX-A12 Vaccine - Medium Dosage Level, IVX-A12 Vaccine + MF59® - Medium 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be eligible to partake in this clinical trial?

"In order to be admitted into the study, candidates must have a healthy subject (HS) score and fall between 60-75 years of age. The trial has capacity for 120 participants."

Answered by AI

Are geriatric patients being considered for this investigation?

"For this particular clinical trial, only those aged between 60 and 75 years old are eligible to participate. Those under 18 have access to 51 trials while individuals older than 65 may consider one of the 371 studies available for them."

Answered by AI

Are there any remaining spots available for enrollment in this experiment?

"Affirmative. Clinicaltrials.gov has declared that this clinical trial is actively enrolling, having been first posted on September 21st 2022 and recently updated on December 22nd 2022. 120 individuals are being recruited across three sites."

Answered by AI

What hazards have been associated with a low dose of the IVX-A12 Vaccine?

"Based on the available data, our team has assigned IVX-A12 Vaccine - Low Dosage Level a safety rating of 1. This first phase trial does not have sufficient evidence to support its efficacy or safety yet."

Answered by AI

What is the total enrollment of participants in this clinical experiment?

"Icosavax, Inc. is responsible for the recruitment of 120 suitable candidates across multiple study sites such as CenExcel ACMR in Atlanta and Meridien Clinical Research in Omaha, Nebraska."

Answered by AI
~56 spots leftby Mar 2025