A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine (IVX-411) in Healthy Adults

• Register: ANZCTR
• Last refreshed on: 12 December 2022
• Main ID: ACTRN12621000738820
• Date of registration: 11/06/2021
• Prospective Registration: No
• Primary sponsor: Icosavax Inc.
• Public title: A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine (IVX-411) in Healthy Adults
• Scientific title: Phase 1/2 Randomized, Observer-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of IVX-411, a Receptor Binding Domain (RBD) SARS-CoV-2 (COVID-19) Virus-Like Particle (VLP) Vaccine, in Healthy SARS-CoV-2 Seronegative and Seropositive Adults (Part 1)
• Date of first enrolment: 07/06/2021
• Target sample size: 84
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12621000738820.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Type of endpoint: Safety;
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Dr Robert Scott

• Name: Dr Robert Scott

Key inclusion & exclusion criteria

Inclusion criteria: 1. Healthy male or female between the ages of 18 and 69 years.
2. SARS-CoV-2 seronegative subjects aged 18 to 69 years, inclusive.
3. Documented SARS-CoV-2 antibody test result prior to Day 0 vaccination (negative result required)
4. Body mass index (BMI) 17 to 35 kg/m2, inclusive, at screening.

Exclusion criteria: 1. a) Receipt of vaccines or medications or vaccines intended to prevent or treat COVID-19 in the past year.
b) Prior receipt of any investigational COVID-19 vaccine, or other investigational or non-registered medicinal product (study drug, biologic, or device) within the past year.
2. Currently enrolled or plan to participate in another clinical trial with an investigational agent (including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) to be received during the study period.
3. Older adult subjects meeting frail elderly criteria (older persons with medical, nutritional, cognitive, emotional, or activity impairments, as defined by the study site); acute or progressive, unstable or uncontrolled clinical conditions.
4. Acute or chronic progressive, unstable or uncontrolled clinical conditions,
5. For all subjects: 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 Study Day 0.
6. 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-411 vaccine, or hypersensitivity to latex.
7. Abnormal function of the immune system resulting from clinical conditions including human immunodeficiency virus, chronic administration of systemic corticosteroids or administration of immunosuppressive chemotherapy, biologics, or radiotherapy within the past 3 months before study randomization.
8. Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
9. Receipt of immunoglobulins or any blood products within the past 3 months before study randomization.
10. BMI greater than 35 kg/m2 at screening.
11. Positive pregnancy test at screening.
12. Refusal to maintain contraceptive practices during the study, and (for women of childbearing potential) to be screened for pregnancy for the duration of the study.



Age minimum: 18 Years
Age maximum: 69 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

SARS-CoV-2 ( COVID-19);
SARS-CoV-2 ( COVID-19)

Infection - Other infectious diseases

Respiratory - Other respiratory disorders / diseases

Intervention(s)

The investigational vaccine, IVX-411, is a computationally-designed recombinant protein virus-like particle (VLP) vaccine under development for the prevention of COVID-19 caused by SARS-CoV-2.
‘IVX-411 study vaccine’ refers to either the aqueous formulation IVX-411a or the adjuvanted formulation IVX-411d. The volume of vaccine formulation to be administered via intramuscular injection is 0.5 mL.
It is a first-in-human (FIH) study to evaluate the safety and immunogenicity of IVX-411 in 84 healthy SARS-CoV-2-seronegative adults 18 to 69 years of age.
The participants will be randomly allocated to one of six IVX-411 formulations (low, medium or high doses with or without MF59) or to the Placebo arm. IVX-411 will be administered intramuscularly as two doses given 28 days apart.
The inclusion of MF59 adjuvant in the vaccine is expected to enhance the immune response and increase the duration of the immune response, which is important in prolonged SARS-CoV-2 circulation and/or ongoing outbreaks.

The dose levels of IVX-411 with or without MF59 are 5, 25 or 125 µg.

Adherence to intervention is not applicable since this is not self-administered and will be administered intramuscularly by trial site personnel as two doses given 28 days apart.

Primary Outcome(s)

To assess the safety of the study drug by assessing Unsolicited Adverse Events.
The unsolicited adverse events will be assessed based on the United States FDA Guidance for Industry: Toxicity Grading Scale for Health Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
[Daily from Day 0 to Day 49 after administration of first dose of study vaccine]

To assess the immunogenicity of the study drug and the requirement for the MF59 adjuvant by a composite outcome: SARS-CoV-2-specific neutralizing antibody titers by live virus assay, spike protein and RBD- specific IgG antibody titers by multiplex assay[Four blood draws on Day 0, Days 28, Day 35, Day 49 after administration of first dose of study vaccine]

To assess the safety of the study drug by assessing solicited local reactions and systemic adverse events within 7 days after each dose.
The local reactions and systemic adverse events will be assessed based on the United States FDA Guidance for Industry: Toxicity Grading Scale for Health Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
[Daily from Day 0 to Day 6 and from Day 28 to Day 34 after administration of first dose of study vaccine]

Secondary Outcome(s)

To assess the immunogenicity of the study drug by evaluating RBD-specific IgG antibody titers by enzyme-linked immunoassay (ELISA)[Five blood draws on Days 0, Day 28, Day 35, Day 49, Day 210 after administration of first dose of study vaccine
]

To assess the safety of the study drug from Adverse Events of Special Interest
This will be based on Safety Platform for Emergency Vaccines (SPAEC) and FDA guidance on potential immune-mediated disorders (PIMDs) and will be coded using the current version of the Medical Dictionary of Regulatory Activities (MedDRA)[Daily from Day 0 to Day 210 after administration of first dose of study vaccine]

To assess the safety of Study drug by the incidence of Serious Adverse Events, Medically-Attended Adverse Events, and Adverse Events leading to study withdrawal
This is a composite secondary outcome which will be graded using Center for Biologics Evaluation and Research (CBER) criteria and will be coded using the current version of the Medical Dictionary of Regulatory Activities (MedDRA)[Daily from Day 0 to Day 210 after administration of first dose of study vaccine]

To assess the safety of the study drug by assessing clinical safety laboratory parameters including hematology and blood chemistry up to 7 days after the second dose[Four blood draws on Days 0, Day 7, Day 28, Day 35 after administration of first dose of study vaccine.]

To assess the immunogenicity of the study drug by evaluating S-specific IgG antibody titers by enzyme-linked immunoassay (ELISA)[Five blood draws on Days 0, Day 28, Day 35, Day 49, Day 210 after administration of first dose of study vaccine
]

To assess the immunogenicity of the study drug by evaluating SARS-CoV-2 NAb titers (pseudovirion assay)[Five blood draws on Days 0, Day 28, Day 35, Day 49, Day 210 after administration of first dose of study vaccine
]

Secondary ID(s)

IVX-411-01

Source(s) of Monetary Support

Icosavax Inc.

Ethics review

Status: Approved
Approval date: 20/05/2021
Contact:

Results

• Results available: Yes
• Date Posted: 02/12/2021
• Date Completed: 09/02/2022