ACTRN12621000882820已完成2 期
A 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 2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 69 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
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