Phase IB Follow-up, Randomized, Controlled, Parallel Group, Patient-blinded, Single-center Study to Assess One Boost With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological + Clinical Activity in Patients Who Have Received the Vaccine Within the Study AFF008
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Affiris AG
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Tolerability
研究概览
简要总结
This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A vaccinations in patients with Parkinson's disease. Patients, who have already participated in AFF008 will be involved and will be receive one boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.
In addition, up to 8 patients will be offered participation within an untreated control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior participation in AFF008 and AFF008E
- •Written informed consent signed and dated by the patient and the caregiver (caregiver is not mandatory)
- •In the investigator's opinion, does not have visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for these
- •Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method
- •Stable doses of PD medications for at least 3 months prior to Visit 0 and during the entire trial period and of all other medications for at least 30 days prior to Visit 1 if considered relevant by the investigator
排除标准
- •Women of childbearing potential without birth control or pregnant women
- •Participation in another clinical trial (except AFF008E) within 3 months before Visit 0
- •History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
- •Autoimmune disease or allergy to components of the vaccine
- •History of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
- •Active infectious disease
- •Immunodeficiency
- •Significant systemic illness or psychiatric illness
- •Alcoholism or substance abuse
- •Prior treatment with experimental immunotherapeutics for PD including IVIG (with the exception of AFFITOPE ® PD01A), with immunosuppressive drugs or treatment with deep brain stimulation
- •Venous status rendering it impossible to place an i.v. access
研究组 & 干预措施
A: AFFITOPE® PD01A + Adjuvant
one injection of 15µg AFFITOPE® PD01A/ adjuvanted
干预措施: AFFITOPE® PD01A (Biological)
B: AFFITOPE® PD01A + Adjuvant
one injection of 75µg AFFITOPE® PD01A/ adjuvanted
干预措施: AFFITOPE® PD01A (Biological)
Control
Untreated control group
干预措施: Control (Other)
结局指标
主要结局
Tolerability
时间窗: 6 month
* Occurrence of any Adverse Events (AE) * Occurrence of any Serious Adverse Events (SAE) * Withdrawal criteria (number of patients who withdraw due to AEs/ reason for withdrawal)
次要结局
- Immunological(6 month)