NCT04447898已完成1 期
A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Study Assessing the Safety and Immune Response of PPV-06 Vaccine in Patient With Inflammatory Knee Osteoarthritis (KOA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Peptinov SAS
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The proportion of patients with DLT defined as grade 3 or higher treatment-related adverse events (monitored in all patients during the study treatment until the End of Study (Week 42) or early termination).
研究概览
简要总结
PPV-06 immunotherapy targets interleukin-6 (IL-6), a key molecule of the immune system whose overproduction is implicated in many inflammatory and autoimmune diseases such as rheumatoid arthritis and osteoarthritis. The benefit of vaccination with PPV-06 is to induce, in response to immunizations, the production of antibodies directed against IL-6. The antibodies produced will neutralize the biological activity of IL-6 involved in the body's inflammatory process.
The primary objective is to evaluate the safety/tolerability of vaccination with PPV-06.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged over 40 years;
- •Diagnosis of primary inflammatory Knee Osteoarthritis (KOA),
- •Body mass index (BMI) of 18-32 kg/m2 at screening;
- •Patients with normal organ function at baseline
- •Contraceptives measures
- •In the investigator's opinion, the patient is capable and willing to comply with the requirements of the study;
- •Willing and able to sign a written informed consent;
- •Affiliated to social security insurance.
排除标准
- •Systemic Autoimmune or immunodeficiency disease;
- •Administration of non-steroidal anti-inflammatory drug (NSAID):
- •Administration of prednisone or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids;
- •Patients treated with biologics such as anti-TNFAlpha, anti-IL-6 and anti-CD-20
- •Participation in another investigational drug or vaccine trial;
- •Knee surgery planned before screening and throughout the study;
- •Knee surgery within the year of baseline;
- •Knee trauma within 2 months of baseline;
- •Chronic hepatitis B and/or C infection. Patients with previous infection, resolved in the past, are eligible;
- •HIV-positivity;
- •History of allergic reaction to any constituents of the study drug;
- •Diagnosis or history of any inflammatory arthritis;
- •Neurologic disorders involving the lower limbs;
- •History of malignancy within the last 5 years;
- •Uncontrolled congestive heart failure or hypertension, unstable heart disease
- •Evidence of any clinically significant abnormality on a chest X-ray which, in the opinion of the investigator, could represent active infection or latent tuberculosis;
- •Moderate or severe acute illness/infection, persistent diarrhea or vomiting on the day of vaccination;
- •Received any licensed, non-live vaccine within the 14 days before receipt of any dose of the study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of any dose of the study vaccine;
- •Receipt of immune globulins, blood or blood-derived products;
- •Pregnant or lactating females;
- •The investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations.
研究组 & 干预措施
High dose
Experimental
50 μg + Montanide™ ISA 51 VG
干预措施: Placebo (Drug)
Low dose
Experimental
10 μg + Montanide™ ISA 51 VG
干预措施: PPV-06 10 μg (Drug)
Low dose
Experimental
10 μg + Montanide™ ISA 51 VG
干预措施: Placebo (Drug)
High dose
Experimental
50 μg + Montanide™ ISA 51 VG
干预措施: PPV-06 50 μg (Drug)
结局指标
主要结局
The proportion of patients with DLT defined as grade 3 or higher treatment-related adverse events (monitored in all patients during the study treatment until the End of Study (Week 42) or early termination).
时间窗: From Baseline to Week 42 (End of Study)
The primary outcome measure of this study is to evaluate the safety/tolerability of PPV-06 vaccination
次要结局
- The quantification of proliferative CD4+T cells assessed by flow cytometry at Baseline, W24, W32 or early termination.(From Baseline to Week 42 (End of Study))
- The occurrence of all adverse events (AEs) and serious adverse events (SAEs), including clinically significant abnormal haematological and biochemical values (monitored during the entire study period until End of Study (Week 42) or early termination).(From Baseline to Week 42 (End of Study))
- The quantification of inflammatory markers will be assessed at Baseline, W4, W12, W16, W24, W32 and End of Study (Week 42) or early termination by measuring IL-6, hsCRP and CRPM level in blood(From Baseline to Week 42 (End of Study))
- The quantification of Anti-IL-6 neutralizing antibody level in vitro at W4, W12, W16, W24, W32 and EoS or early termination(From Baseline to Week 42 (End of Study))
- The quantification of Anti-IL-6 antibody production, isotypes characterization and anti-CRM197 antibody level in serum at Baseline, W4, W12, W16, W24, W32 and EoS or early termination(From Baseline to Week 42 (End of Study))
- The quantification of specific T cell response and polarization (Th1, Th2 and Th17) assessed by IFNg, IL-5 and IL-17 Elispot assay at Baseline, W24, W32 or early termination.(From Baseline to Week 42 (End of Study))
- The frequency of hIL-6 epitope-specific memory B cells assessed by ELISPOT assay, at Baseline, W24, W32 or early termination.(From Baseline to Week 42 (End of Study))
研究者
研究点 (1)
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