Safety and Immunogenicity of IVX-A12 in Healthy Older Adults

• ClinicalTrials.gov Identifier: NCT05664334
• Recruitment Status: Completed
• First Posted: December 23, 2022
• Last Update Posted: March 5, 2024
• Sponsor: Icosavax, Inc.
• Information provided by (Responsible Party): Icosavax, Inc.

Tracking Information

• First Submitted Date: December 7, 2022
• First Posted Date: December 23, 2022
• Last Update Posted Date: March 5, 2024
• Actual Study Start Date: September 21, 2022
• Actual Primary Completion Date: January 24, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 22, 2022)

• Proportion of Participants With Solicited Local Reactions and Systemic AEs [ Time Frame: Within 7 days After the Dose (From Day 0 to Day 6) ]
• Proportion of Participants With Unsolicited AEs [ Time Frame: 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) [ Time Frame: At Day 28 ]
• Proportion of Participants With RSV and hMPV Immunoglobulin G (IgG) Prefusion F Protein-specific Antibody Titers [ Time Frame: At Day 28 ]
  RSV and hMPV IgG prefusion F protein-specific antibody titers as measured by enzyme-linked immunosorbent assays (ELISAs).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 22, 2022)

• 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 [ Time Frame: From Day 0 up to the end of study (Day 365) ]
• Proportion of Participants With Clinically Significant Safety Laboratory Abnormalities [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From Day 0 up to Day 180 ]
  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).
• GMFR in Serum for RSV and hMPV IgG Prefusion F Protein-specific Antibody Titers [ Time Frame: From Day 0 up to Day 180 ]
  GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Immunogenicity of IVX-A12 in Healthy Older Adults
• Official Title: 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
• 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.

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).

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Other
• Condition: Healthy

Intervention

• 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

Study Arms

• Experimental: IVX-A12 Vaccine - Low Dosage Level
  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.
  Interventions:

  • Biological: IVX-121
  • Biological: IVX-241
• Experimental: IVX-A12 Vaccine + MF59® - Low Dosage Level
  Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
  Interventions:

  • Biological: IVX-121
  • Biological: IVX-241
  • Other: MF59®
• Experimental: IVX-A12 Vaccine - Medium Dosage Level
  Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
  Interventions:

  • Biological: IVX-121
  • Biological: IVX-241
• Experimental: IVX-A12 Vaccine + MF59® - Medium Dosage Level
  Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
  Interventions:

  • Biological: IVX-121
  • Biological: IVX-241
  • Other: MF59®
• Experimental: IVX-A12 Vaccine - High Dosage Level
  Participants will receive IVX-A12 vaccine (bivalent combination formulation containing IVX-121 and IVX-241 VLPs), administered IM once on Day 0.
  Interventions:

  • Biological: IVX-121
  • Biological: IVX-241
• Placebo Comparator: Placebo
  Participants will receive placebo, administered IM once on Day 0.
  Intervention: Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 4, 2024): 140
• Original Estimated Enrollment (submitted: December 22, 2022): 120
• Actual Study Completion Date: January 24, 2024
• Actual Primary Completion Date: January 24, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

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

  1. Receipt of licensed vaccines is permitted after completion of the study Day 28 visit.
  2. 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05664334
• Other Study ID Numbers: ICVX-12-101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Icosavax, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Icosavax, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Icosavax, Inc.
• Verification Date: March 2024