IVX-A12 for Healthy Older Adults

Recruiting at 3 trial locations

Overseen By Icosavax Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Icosavax, Inc.

Must not be taking: Systemic corticosteroids, Immunosuppressive chemotherapy

Disqualifiers: Severe cardiopulmonary disease, Frail elderly, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

140 Participants Needed

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

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.

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

Group I: IVX-A12 Vaccine - Medium Dosage Level Experimental Treatment 2 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 Level Experimental Treatment 2 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 Level Experimental Treatment 2 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 Level Experimental Treatment 3 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 Level Experimental Treatment 3 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: Placebo Placebo Group 1 Intervention

Participants will receive placebo, administered IM once on Day 0.

Who Is Running the Clinical Trial?

Icosavax, Inc.

Lead Sponsor

Trials

3

Recruited

550+