Safety and Immunogenicity of IVX-A12 in Healthy Older Adults

NCT05664334 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ICVX-12-101
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Healthy

Keywords

Respiratory Syncytial Virus; Human Metapneumovirus; Bivalent Combination Virus-like Particle Protein Subunit Vaccine

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• 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

  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

  From Day 0 up to Day 180

• GMFR in Serum for RSV and hMPV IgG Prefusion F Protein-specific Antibody Titers

  From Day 0 up to Day 180

Study Arms (6)

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.

Biological: IVX-121; Biological: IVX-241

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.

Biological: IVX-121; Biological: IVX-241; Other: MF59®

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.

Biological: IVX-121; Biological: IVX-241

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.

Biological: IVX-121; Biological: IVX-241; Other: MF59®

IVX-A12 Vaccine - High 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.

Biological: IVX-121; Biological: IVX-241

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

IVX-121 BIOLOGICAL

75 mcg of IVX-121 without MF59®

IVX-A12 Vaccine - Low Dosage Level

IVX-241 BIOLOGICAL

75 mcg of IVX-241 without MF59®

IVX-A12 Vaccine - Low Dosage Level

Placebo BIOLOGICAL

Diluent

Placebo

MF59® OTHER

MF59® as an adjuvant

IVX-A12 Vaccine + MF59® - Low Dosage Level; IVX-A12 Vaccine + MF59® - Medium Dosage Level

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Participants able to voluntarily give written informed consent and to comply with study procedures including follow-up to approximately 12 months after first dosing
• Body mass index (BMI) 17 to 35 kilogram per square meter (kg/m\^2), inclusive, at screening
• Screening laboratory values must be within the laboratory reference ranges or deemed not clinically significant if within Grade 1 severity on the toxicity scale

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Icosavax, Inc.: lead

Study Sites (4)

CenExcel RCA

Hollywood, Florida, 33024, United States

Location

CenExcel ACMR

Atlanta, Georgia, 30331, United States

Location

Meridien Clinical Research

Omaha, Nebraska, 68134, United States

Location

PanAmerican Clinical Research

Brownsville, Texas, 78520, United States

Location

MeSH Terms

Interventions

MF59 oil emulsion

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 23, 2022
• Study Start: September 21, 2022
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)