Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)

Affiris

Status and phase

Completed

Phase 1

Conditions

Parkinson's Disease

Treatments

Biological: AFFITOPE® PD01A

Study type

Interventional

Funder types

Industry

Identifiers

NCT02618941

2015-004854-16 (EudraCT Number)

AFFiRiS 008AA

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 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.

Enrollment

26 patients

Sex

All

Ages

40 to 68 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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