Phase IB Follow-up, Controlled, Parallel Group, Single-center Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological and Clinical Activity in Patients Who Have Participated in the AFF008 Program
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Affiris AG
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Occurrence of any Serious Adverse Events (SAE) that are related to the study drug
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 the AFF008 program will be involved and will receive a second boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.
In addition, up to 6 patients will be offered participation within an untreated control Group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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, AFF008E and AFF008A
- •Written informed consent signed and dated by the patient and, preferentially, the caregiver
- •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
- •All changes in conventional PD therapies must be available to the sponsor; in particular pharmacologic symptomatic PD medication allowing transformation to a Levodopa standard dose
- •A potential participant should be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except PD therapies, these will be recorded separately) 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 within 3 months before Visit 1 (except AFF008A)
- •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: non-melanoma skin cancer, intraepithelial cervical neoplasia)
- •Active infectious disease (e.g., Hepatitis B, C)
- •Immunodeficiency
- •Significant systemic illness
- •Alcoholism or substance abuse
- •Prior and/or current treatment with experimental immunotherapeutics including IVIG with the exception of AFFITOPE® PD01A, with immune modulating 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
AFFITOPE® PD01A + Adjuvant
one injection of 75µg AFFITOPE® PD01A/adjuvanted
干预措施: AFFITOPE® PD01A (Biological)
Control
Untreated control group
结局指标
主要结局
Occurrence of any Serious Adverse Events (SAE) that are related to the study drug
时间窗: 12 months
Number of patients who withdraw due to Adverse Events (AEs)
时间窗: 12 months
The withdrawal criteria (continuation decision) in regards to the number of patients who withdraw due to AEs as well as the reason for withdrawal will be evaluated.
Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination
时间窗: 12 months
次要结局
- Immunological activity of AFFITOPE® vaccine PD01A(12 months)