CompletedPhase 1

Safety and Immunogenicity of IVX-A12 in Healthy Older Adults

United States140 participantsStarted 2022-09-21

Plain-language summary

The main purpose of this study is to evaluate the safety and immunogenicity of three dosage levels (low, medium, high) of the bivalent combination respiratory syncytial virus (RSV)/human metapneumovirus (hMPV) virus-like particle (VLP) candidate vaccine (IVX-A12), compared to placebo, when administered as a single-dose regimen in healthy older adults 60 to 75 years of age.

Who can participate

Age range60 Years – 75 Years

SexALL

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Exclusion criteria

✕. Receipt of licensed vaccines is permitted after completion of the study Day 28 visit.
✕. Receipt of licensed COVID-19 vaccines is permitted if dosing regimen completed within 21 days prior to study vaccine administration on Day 0 or after completion of the Day 28 visit.

What they're measuring

Proportion of Participants With Solicited Local Reactions and Systemic AEs

Timeframe: Within 7 days After the Dose (From Day 0 to Day 6)

Proportion of Participants With Unsolicited AEs

Timeframe: Up to 28 days After the Dose (From Day 0 to Day 28)

Proportion of Participants With RSV/A, RSV/B, hMPV/A and hMPV/B Neutralizing Antibodies (NAb)

Timeframe: At Day 28

Proportion of Participants With RSV and hMPV Immunoglobulin G (IgG) Prefusion F Protein-specific Antibody Titers

Timeframe: At Day 28

Trial details

NCT IDNCT05664334

SponsorIcosavax, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-24

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