ACTRN12621000738820已完成1 期
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)
适应症
试验速览
- 阶段
- 1 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 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.
排除标准
- •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.
研究者
相似试验
进行中（未招募）
不适用
Extension of a study conducted in adolescent and young adult healthy subjects to evaluate safety and antibody response after the administration of a booster dose of the investigational vaccine directed against Meningococcal A, B, C, Y and W strains 24 months after the second dose.This study will evaluate the safety and immunogenicity of a booster dose of MenABCWY vaccineeither MenABCWY+OMV or MenABCWY+1/4OMV, administered to adolescent and young adults who previously received the same MenABCWY formulation in the primary study V102_03. This extension study will also assess the safety and immunogenicity non-inferiority of a single dose of MenABCWY in subject who received two doses of Bexsero or a single dose of Menveo in the primary study.MedDRA version: 19.0Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-003937-41-PLGSK Vaccines S.r.l484
进行中（未招募）
1 期
A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)MedDRA version: 12.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosusEUCTR2009-012059-47-FReovacs SA28
进行中（未招募）
1 期
A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses followed by a 2nd dose of the RSV vaccine to Healthy non-Pregnant Women.Healthy Volunteers (prevention of lower respiratory tract illness)EUCTR2019-002258-22-BEGlaxoSmithKline Biologicals500
已完成
2 期
A Study Looking at the Safety and Effectiveness of a COVID-19 Vaccine Plus Adjuvant in South African AdultsCOVID-19PACTR202009726132275ovavax Inc4,704
进行中（未招募）
不适用
A phase I/IIa randomized, observer-blind, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of the GSK Biologicals’ herpes zoster vaccine, gE/AS01B in comparison to placebo when administered as 3 doses to adult HIV-infected subjects. - ZOSTER-015EUCTR2009-017809-11-DEGlaxoSmithKline Biologicals135