Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008A)

Affiris

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Biological: AFFITOPE® PD01A; Other: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT02216188

AFFiRiS 008A

2014-002489-54 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 40 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 3 patient groups

A: AFFITOPE® PD01A + Adjuvant

Experimental group

Description:

one injection of 15µg AFFITOPE® PD01A/ adjuvanted

Treatment:

Biological: AFFITOPE® PD01A

B: AFFITOPE® PD01A + Adjuvant

Experimental group

Description:

one injection of 75µg AFFITOPE® PD01A/ adjuvanted

Treatment:

Biological: AFFITOPE® PD01A

Control

Other group

Description:

Untreated control group

Treatment:

Other: Control