NCT05035680撤回1 期
Proof of Concept Trial of Adjuvant Activity of SWE, a Squalene-based -Oil-in-water Emulsion
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Characterize the severe/serious adverse event (SAE) burden of SWE combined with a seasonal influenza vaccine over 28 days.
研究概览
简要总结
The purpose of the study is to characterize safety and tolerability of the squalene-based adjuvant candidate SWE and its potential to enhance the immune response to seasonal influenza vaccine antigens in healthy older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be willing to participate in the study, as demonstrated by signing the written informed consent form approved by the Ethics Committee/Institutional Review Board (EC/IRB) before any study procedure is performed.
- •Be able to comprehend the full nature and purpose of the study, including possible risks.
- •Be a healthy male or female without acute or chronic medical condition per the Investigator's judgement between 18 to 50 years of age (Part 1) and ≥65 years of age (Part 2) on the day of randomization, inclusive.
- •Have a BMI between 18.0 kg/m2 and 32.0 kg/m
- •BMI values should be rounded to the nearest integer (e.g., round down 32.4 to 32.0, round up 18.6 to 19.0).
- •All female participants: have a negative pregnancy test or post-menopausal status. Postmenopausal status is defined as 12 months with no menses without alternative medical cause. Female participants of childbearing potential (Part 1): have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to randomization, not breastfeeding, and willing to use highly effective methods of contraception 14 days before study drug administration through last scheduled follow up visit (End of Study). Male participants with female partners of child-bearing potential (Part 1): agree to use one of the following contraception methods from the day of randomization to the last follow-up visit of the partner: vasectomy with documentation of azoospermia, or male condom use; agree to not donate sperm prior to the last scheduled follow-up visit (End of Study).
- •Be able to co-operate with the study staff and comply with the requirements of the study.
排除标准
- •Have a history of intolerance, hypersensitivity, or allergy to any component of the study products and/or have a history of anaphylaxis to any drug or vaccines.
- •Have a history of Guillain-Barre Syndrome
- •Have a clinically significant history of hepatic, renal, cardiovascular, or any other disease or disorder, including psychological or psychiatric, that in the investigator's opinion may increase the risk to the participant, and/or jeopardize the participant's compliance with the study procedures.
- •Have a history of primary immunodeficiency or secondary immunodeficiency including HIV and anatomical or functional asplenia.
- •Have one or more abnormal laboratory values at the screening visit that in the opinion of the Investigator, are clinically significant, including but not limited to the following: Alanine Aminotransferase (ALT) > 2 x upper limit of normal (ULN) Serum creatinine above the ULN Bilirubin > 2 x ULN Internal Normalized Ratio (INR), Prothrombin Time (PT), Partial Thromboplastin Time (PTT) above the ULN Hemoglobin < 12 g/dL in men, and <11 g/dL in women Platelets below the lower limit of normal (LLN)
- •Have had clinical signs and symptoms consistent with Coronavirus Disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV2) infection-19 (COVID-19), i.e. fever, cough, dyspnea, sore throat, fatigue, loss of smell, loss of taste, or confirmed SARS-CoV-2 infection by appropriate laboratory test in the 1 month preceding the screening visit.
- •Have had influenza-like illness (ILI) in the 3 months preceding the screening visit. ILI is defined as fever (oral temperature ≥37.8 C / ≥100 F) and cough or sore throat (CDC definition).
- •Have received an investigational drug or vaccine in the 3 months preceding the screening visit, including COVID-19 investigational vaccine or treatment. Note: vaccination with an approved vaccine for the prevention of COVID-19 is allowed.
- •Have taken immunosuppressants and oral or parenteral corticosteroids in the 6 months preceding the screening visit. Inhaled corticosteroids for asthma are allowed.
- •Have received any influenza vaccine in the current and past season, i.e. in the 8 months preceding the screening visit.
- •Have a history of drug or alcohol abuse in the 1 year preceding the screening visit.
- •Have a history of basal cell carcinoma or non-invasive squamous cell carcinoma of the skin in the 1 year preceding the screening visit and/or a history of any other malignancy in the 5 years preceding the screening visit.
- •Have any other condition or situation that in the investigator's opinion might increase the risk to the participant or jeopardize the participant's compliance with study procedures.
结局指标
主要结局
Characterize the severe/serious adverse event (SAE) burden of SWE combined with a seasonal influenza vaccine over 28 days.
时间窗: 28 days
Severe and serious unsolicited TEAEs from Day 1 through Day 28
Characterize the adjuvant effect of SWE on the hemagglutinin inhibition (HI) antibody response to the A/H3N2 vaccine strain.
时间窗: Day 29
HI antibody titer to the influenza A H3N2 (A/H3N2) vaccine strain on Day 29
次要结局
- Characterize treatment-emergent adverse events (TEAEs) of SWE and MF59 combined with a seasonal influenza vaccine.(169 Days (End of Study))
- Characterize reactogenicity of SWE and MF59 combined with a seasonal influenza vaccine.(7 days)
- Characterize safety laboratory values.(29 Days and 169 Days (End of Study))
- Characterize the adjuvant effect of SWE on HI antibody responses to homologous and heterologous influenza vaccine strains through HI antibody titer, peripheral blood mononuclear cell(PBMC), and exploratory laboratory assessments.(Day 29 and Day 169)
研究者
相似试验
终止
1 期
Pertussis Acellular Vaccine Adjuvanted With TQL1055PertussisNCT04793620Adjuvance Technologies, Inc.72
Unknown
1 期
Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot UlcersDiabetic Foot UlcerNCT03166423University of Chile90
进行中（未招募）
1 期
A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™Malaria,FalciparumNCT06320535University of Oxford36
终止
1 期
A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast CancerER+ / HER2- Advanced Breast CancerNCT05103826Jiangsu HengRui Medicine Co., Ltd.3
已完成
1 期
A Phase I Study of the Chimeric Anti-CD40 Monoclonal Antibody ChiLob 7/4 to Treat Advanced Malignancies Refractory to Conventional Anti-cancer TreatmentNeoplasmsNon-HodgkinB-CellCancerLymphomaNCT01561911Cancer Research UK29