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Trial registered on ANZCTR


Registration number
ACTRN12621000738820
Ethics application status
Approved
Date submitted
28/04/2021
Date registered
11/06/2021
Date last updated
11/06/2021
Date data sharing statement initially provided
11/06/2021
Type of registration
Retrospectively registered

Titles & IDs
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)
Secondary ID [1] 303903 0
IVX-411-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 ( COVID-19) 321488 0
Condition category
Condition code
Respiratory 319241 319241 0 0
Other respiratory disorders / diseases
Infection 319502 319502 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320209 0
Treatment: Drugs
Comparator / control treatment
Placebo: Placebo will be a sterile aqueous diluent, delivered as a 0.5 mL dose.
Control group
Placebo

Outcomes
Primary outcome [1] 327111 0
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
Timepoint [1] 327111 0
Daily from Day 0 to Day 6 and from Day 28 to Day 34 after administration of first dose of study vaccine
Primary outcome [2] 327112 0
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
Timepoint [2] 327112 0
Daily from Day 0 to Day 49 after administration of first dose of study vaccine
Primary outcome [3] 327113 0
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
Timepoint [3] 327113 0
Four blood draws on Day 0, Days 28, Day 35, Day 49 after administration of first dose of study vaccine
Secondary outcome [1] 393846 0
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)
Timepoint [1] 393846 0
Daily from Day 0 to Day 210 after administration of first dose of study vaccine
Secondary outcome [2] 393847 0
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)
Timepoint [2] 393847 0
Daily from Day 0 to Day 210 after administration of first dose of study vaccine
Secondary outcome [3] 393848 0
To assess the immunogenicity of the study drug by evaluating SARS-CoV-2 NAb titers (pseudovirion assay)
Timepoint [3] 393848 0
Five blood draws on Days 0, Day 28, Day 35, Day 49, Day 210 after administration of first dose of study vaccine
Secondary outcome [4] 393849 0
To assess the immunogenicity of the study drug by evaluating S-specific IgG antibody titers by enzyme-linked immunoassay (ELISA)
Timepoint [4] 393849 0
Five blood draws on Days 0, Day 28, Day 35, Day 49, Day 210 after administration of first dose of study vaccine
Secondary outcome [5] 394136 0
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
Timepoint [5] 394136 0
Four blood draws on Days 0, Day 7, Day 28, Day 35 after administration of first dose of study vaccine.
Secondary outcome [6] 396486 0
To assess the immunogenicity of the study drug by evaluating RBD-specific IgG antibody titers by enzyme-linked immunoassay (ELISA)
Timepoint [6] 396486 0
Five blood draws on Days 0, Day 28, Day 35, Day 49, Day 210 after administration of first dose of study vaccine

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
69 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation procedures is per Interactive web response system (IWRS): an online randomization system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Interactive web response system (IWRS) will be used for treatment allocation and randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/06/2021
Date of last participant enrolment
Anticipated
20/09/2021
Actual
Date of last data collection
Anticipated
15/03/2022
Actual
Sample size
Target
84
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19071 0
University of Sunshine Coast Health Clinics - Sippy Downs
Recruitment postcode(s) [1] 33621 0
4556 - Sippy Downs

Funding & Sponsors
Funding source category [1] 308295 0
Commercial sector/Industry
Name [1] 308295 0
Icosavax Inc.
Address [1] 308295 0
1616 EASTLAKE AVE E, SUITE 210 SEATTLE WA 98102
Country [1] 308295 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Icosavax Inc.
Address
1616 EASTLAKE AVE E, SUITE 210 SEATTLE WA 98102
Country
United States of America
Secondary sponsor category [1] 309100 0
None
Name [1] 309100 0
Address [1] 309100 0
Country [1] 309100 0
Other collaborator category [1] 281715 0
Commercial sector/Industry
Name [1] 281715 0
Novotech (Australia) Pty Limited
Address [1] 281715 0
Level 3, 235 Pyrmont Street, Pyrmont NSW 2009
Country [1] 281715 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308269 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 308269 0
Commercial Road, Melbourne 3004, VIC
Ethics committee country [1] 308269 0
Australia
Date submitted for ethics approval [1] 308269 0
29/04/2021
Approval date [1] 308269 0
20/05/2021
Ethics approval number [1] 308269 0
254/21

Summary
Brief summary
This 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 study will also investigate whether an adjuvant is required in the formulation to enhance immune responses to IVX-411. The selected adjuvant, MF59®, is an oil-in-water emulsion that has shown to increase immunogenicity and is associated with a good safety and tolerability profile.
The stopping rules and safety will be monitored by an internal safety review committee (iSRC) and a Safety Monitoring Committee.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110138 0
Dr Robert Scott
Address 110138 0
USC Moreton Bay- Health Hub Morayfield
Level 1, 19-31 Dickson Road
Morayfield QLD 4506 Australia
Country 110138 0
Australia
Phone 110138 0
+61 0754563965
Fax 110138 0
Email 110138 0
rscott2@usc.edu.au
Contact person for public queries
Name 110139 0
Dr Robert Scott
Address 110139 0
USC Moreton Bay- Health Hub Morayfield
Level 1, 19-31 Dickson Road
Morayfield QLD 4506 Australia
Country 110139 0
Australia
Phone 110139 0
+61 0754563965
Fax 110139 0
Email 110139 0
rscott2@usc.edu.au
Contact person for scientific queries
Name 110140 0
Dr Robert Scott
Address 110140 0
USC Moreton Bay- Health Hub Morayfield
Level 1, 19-31 Dickson Road
Morayfield QLD 4506 Australia
Country 110140 0
Australia
Phone 110140 0
+61 0754563965
Fax 110140 0
Email 110140 0
rscott2@usc.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results