COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12621000882820.aspx

Dr Robert Scott

rscott2@usc.edu.au

2021-07-08

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1. Healthy male or female between the ages of 18 and 69 years 2. SARS-CoV-2 seropositive subjects aged 18 to 69 years, inclusive (including subjects who received a COVID-19 vaccine 3-6 months prior to booster and excluding subjects with a history of prior COVID-19 infection) 3. Documented SARS-CoV-2 antibody test result prior to Day 0 vaccination (documentation of prior licensed or provisionally approved SARS-CoV-2 vaccination is required) 4. Body mass index (BMI) 17 to 35 kg/m2, inclusive, at screening

1. 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. Receipt of licensed SARS-CoV-2 vaccines is permitted if the dosing regimen is completed within 3 to 6 months prior to study vaccine administration on 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 serum beta hCG 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.

2

Icosavax Inc.

18

69

Australia

Healthy volunteers

N/A

84

To assess the safety of the study drug by assessing solicited local reactions and systemic adverse events within 7 days after single booster 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 7 after administration of single booster dose of study vaccine];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 21 after administration of single booster 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; Day 7; Days 28; Day 49 after administration of single booster dose of study vaccine]

Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "0.5mL booster dose;IM", "treatment_id": 695, "treatment_name": "Ivx-411", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]