140 Participants Needed

IVX-A12 for Healthy Older Adults

Recruiting at 3 trial locations
IC
Overseen ByIcosavax Clinical Operations

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that affect the immune system, like high-dose corticosteroids or immunosuppressive drugs, you may not be eligible to participate.

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Screening laboratory values must be within the laboratory reference ranges or deemed not clinically significant if within Grade 1 severity on the toxicity scale
Healthy male or non-pregnant female older adults 60 to 75 years of age at the time of first vaccination
Participants with stable well-controlled chronic conditions such as hypertension without clinical exacerbation of their underlying disease within the previous 12 months
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Exclusion 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.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular injection of the IVX-A12 vaccine or placebo on Day 0

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with assessments of antibody titers and serum neutralization antibodies

365 days
Multiple visits over 1 year

Treatment Details

Interventions

  • IVX-A12
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icosavax, Inc.

Lead Sponsor

Trials
3
Recruited
550+
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