Trials / Completed
CompletedNCT05664334
Safety and Immunogenicity of IVX-A12 in Healthy Older Adults
A Phase 1 Randomized, Observer-blind, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Immunogenicity of IVX-A12, a Respiratory Syncytial Virus and Human Metapneumovirus Bivalent Combination Virus-like Particle Protein Subunit Vaccine, in Healthy Adults, 60 to 75 Years of Age
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Icosavax, Inc. · Industry
- Sex
- All
- Age
- 60 Years – 75 Years
- Healthy volunteers
- Accepted
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.
Detailed description
The Phase 1 clinical trial of IVX-A12 is a randomized, observer-blinded, placebo-controlled, multi-center study designed to evaluate the safety and immunogenicity of multiple dosage levels of IVX-A12, with and without CSL Seqirus' proprietary adjuvant MF59®. A total of up to 120 healthy older adults aged 60 to 75 years. Participants will be administered a single shot of IVX-A12, at one of three combination dosage levels below, or placebo. The overall duration of the study is up to 1 year (365 days).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IVX-121 | 75 mcg of IVX-121 without MF59® |
| BIOLOGICAL | IVX-241 | 75 mcg of IVX-241 without MF59® |
| BIOLOGICAL | Placebo | Diluent |
| BIOLOGICAL | IVX-121 | 75 mcg of IVX-121, without MF59® |
| BIOLOGICAL | IVX-241 | 150 mcg IVX-241, without MF59® |
| BIOLOGICAL | IVX-241 | 225 mcg of IVX-241, without MF59® |
| BIOLOGICAL | IVX-121 | 75 mcg of IVX-121, with MF59® |
| BIOLOGICAL | IVX-241 | 75 mcg of IVX-241, with MF59® |
| BIOLOGICAL | IVX-241 | 150 mcg IVX-241, with MF59® |
| OTHER | MF59® | MF59® as an adjuvant |
Timeline
- Start date
- 2022-09-21
- Primary completion
- 2024-01-24
- Completion
- 2024-01-24
- First posted
- 2022-12-23
- Last updated
- 2024-03-05
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05664334. Inclusion in this directory is not an endorsement.