Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVX-A12 Vaccine - Low Dosage Level | Experimental | 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. |
|
| IVX-A12 Vaccine + MF59® - Low Dosage Level | Experimental | Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0. |
|
| IVX-A12 Vaccine - Medium Dosage Level | Experimental | Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0. |
|
| IVX-A12 Vaccine + MF59® - Medium Dosage Level | Experimental | Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0. |
|
| IVX-A12 Vaccine - High Dosage Level | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVX-121 | Biological | 75 mcg of IVX-121 without MF59® |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Solicited Local Reactions and Systemic AEs | Within 7 days After the Dose (From Day 0 to Day 6) | |
| Proportion of Participants With Unsolicited AEs | 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) | At Day 28 | |
| Proportion of Participants With RSV and hMPV Immunoglobulin G (IgG) Prefusion F Protein-specific Antibody Titers | RSV and hMPV IgG prefusion F protein-specific antibody titers as measured by enzyme-linked immunosorbent assays (ELISAs). | At Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With at Least One Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), AEs of Special Interest (AESIs) and AEs Leading to Study Withdrawal | From Day 0 up to the end of study (Day 365) | |
| Proportion of Participants With Clinically Significant Safety Laboratory Abnormalities |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Prior receipt of any investigational RSV or hMPV vaccine
Prior receipt of another investigational medicinal product (study drug, biologic, or device) not authorized for use in the United States and European Union within the past year
Laboratory-confirmed severe RSV or hMPV infection within the past year prior to enrollment
Currently enrolled or plan to participate in another clinical study with an investigational agent (including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) to be received during the study period
Presence of high-risk comorbidities for severe RSV or hMPV disease (example, significant cardiopulmonary disease)
Older adults meeting frail elderly criteria (older persons with medical, nutritional, cognitive, emotional, or activity impairments, as defined by the study site)
Acute or chronic progressive, unstable or uncontrolled clinical conditions
Acute illness, with or without fever at the time of planned vaccination
History of hypersensitivity or serious adverse reactions to vaccines, such as anaphylaxis, Guillain-Barré, and angioedema, or any known allergies to any component of the IVX-121 and/or IVX-241 vaccine, or hypersensitivity to latex
Abnormal function of the immune system resulting from clinical conditions including human immunodeficiency virus, chronic administration of systemic corticosteroids (oral/intravenous/IM at a dose equivalent of greater than (>) 20 milligrams (mg) prednisone in a period of more than 14 days), or administration of immunosuppressive chemotherapy, biologics, or radiotherapy within the past 3 months before study randomization
Refusal to maintain contraceptive practices during the study, and (for women of childbearing potential) to be screened for pregnancy at specified times during the study
Receipt of licensed inactivated vaccines including influenza vaccine within 14 days prior to study vaccine administration on Study Day 0, or with live virus vaccines within 30 days of Day 0
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExcel RCA | Hollywood | Florida | 33024 | United States | ||
| CenExcel ACMR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C089950 | MF59 oil emulsion |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0. |
|
| Placebo | Placebo Comparator | Participants will receive placebo, administered IM once on Day 0. |
|
| IVX-241 |
| Biological |
75 mcg of IVX-241 without MF59® |
|
| Placebo | Biological | Diluent |
|
| IVX-121 | Biological | 75 mcg of IVX-121, without MF59® |
|
| IVX-241 | Biological | 150 mcg IVX-241, without MF59® |
|
| IVX-241 | Biological | 225 mcg of IVX-241, without MF59® |
|
| IVX-121 | Biological | 75 mcg of IVX-121, with MF59® |
|
| IVX-241 | Biological | 75 mcg of IVX-241, with MF59® |
|
| IVX-241 | Biological | 150 mcg IVX-241, with MF59® |
|
| MF59® | Other | MF59® as an adjuvant |
|
| At screening, and after dosing, at Days 0, 7, and 28 |
| Proportion of Participants With RSV/A, RSV/B, hMPV/A and hMPV/B Specific NAbs RSV and hMPV IgG Prefusion F Protein-specific Antibody Titers, RSV and hMPV IgG prefusion F protein-specific antibody titers | At Days 0, 7, 180, and 365 |
| Geometric Fold Rise (GMFR) in Serum for Anti-RSV/A, RSV/B, hMPV/A and hMPV/B Specific NAb | Serum samples will be collected and the titers of serum neutralization antibodies will be assessed. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0). | From Day 0 up to Day 180 |
| GMFR in Serum for RSV and hMPV IgG Prefusion F Protein-specific Antibody Titers | GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0). | From Day 0 up to Day 180 |
| Atlanta |
| Georgia |
| 30331 |
| United States |
| Meridien Clinical Research | Omaha | Nebraska | 68134 | United States |
| PanAmerican Clinical Research | Brownsville | Texas | 78520 | United States |