Clinical Trial Details

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

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Trial Information

Broad Health Condition Respiratory
Infection

Specific Health ConditionOther respiratory disorders / diseases
Other infectious diseases

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
University of Sunshine Coast Health Clinics - Sippy Downs


Postcode
4556 - Sippy Downs

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Trial 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.

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 age18 Years

Maximum age69 Years

GenderBoth 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.

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Icosavax Inc.
Primary Sponsor Address: 1616 EASTLAKE AVE E, SUITE 210 SEATTLE WA 98102
Primary Sponsor Country: United States of America

Trial IDACTRN12621000738820

Contact person for information and recruitmentDr
Robert Scott
USC Moreton Bay- Health Hub Morayfield Level 1, 19-31 Dickson Road Morayfield QLD 4506 Australia
+61 0754563965

Further information iconrscott2@usc.edu.au
Australia