Safety and Immunogenicity of IVX-A12 in Healthy Older Adults

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05664334
• Other study ID #: ICVX-12-101
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2022
• Est. completion date: January 24, 2024

Study information

• Verified date: March 2024
• Source: Icosavax, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 24, 2024
• Est. primary completion date: January 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• IVX-121
75 mcg of IVX-121 without MF59®
• IVX-241
75 mcg of IVX-241 without MF59®
• Placebo
Diluent
• IVX-121
75 mcg of IVX-121, without MF59®
• IVX-241
150 mcg IVX-241, without MF59®
• IVX-241
225 mcg of IVX-241, without MF59®
• IVX-121
75 mcg of IVX-121, with MF59®
• IVX-241
75 mcg of IVX-241, with MF59®
• IVX-241
150 mcg IVX-241, with MF59®

Other:
• MF59®
MF59® as an adjuvant

Locations

Country	Name	City	State
United States	CenExcel ACMR	Atlanta	Georgia
United States	PanAmerican Clinical Research	Brownsville	Texas
United States	CenExcel RCA	Hollywood	Florida
United States	Meridien Clinical Research	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Icosavax, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Solicited Local Reactions and Systemic AEs		Within 7 days After the Dose (From Day 0 to Day 6)
Primary	Proportion of Participants With Unsolicited AEs		Up to 28 days After the Dose (From Day 0 to Day 28)
Primary	Proportion of Participants With RSV/A, RSV/B, hMPV/A and hMPV/B Neutralizing Antibodies (NAb)		At Day 28
Primary	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	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)
Secondary	Proportion of Participants With Clinically Significant Safety Laboratory Abnormalities		At screening, and after dosing, at Days 0, 7, and 28
Secondary	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
Secondary	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
Secondary	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