None listed
Conditions
Brief summary
This is a Phase 2 assessment of booster vaccination with IVX-411 in up to 84 healthy adults who have been previously vaccinated with licensed vaccine against SARS-CoV-2 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.
Interventions
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 Phase 2 assessment of booster vaccination with IVX-411 in up to 84 healthy adults who have be
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 Phase 2 assessment of booster vaccination with IVX-411 in up to 84 healthy adults who have been fully vaccinated with a licensed vaccine against SARS-CoV-2. Licensed SARS-CoV-2 vaccine dosing regimen must have been completed within 3 to 6 months prior to study vaccine administration on study Day 0 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 will administer a single booster dose at Day 0 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.
Sponsors
Icosavax Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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.
Outcome results
None listed