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

• ClinicalTrials.gov Identifier: NCT02216188
• Recruitment Status: Completed
• First Posted: August 13, 2014
• Last Update Posted: August 17, 2015
• Sponsor: Affiris AG
• Information provided by (Responsible Party): Affiris AG

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease	Biological: AFFITOPE® PD01A; Other: Control	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: August 2014
• Actual Primary Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: A: AFFITOPE® PD01A + Adjuvant; one injection of 15µg AFFITOPE® PD01A/ adjuvanted	Biological: AFFITOPE® PD01A; s.c. injection
Experimental: B: AFFITOPE® PD01A + Adjuvant; one injection of 75µg AFFITOPE® PD01A/ adjuvanted	Biological: AFFITOPE® PD01A; s.c. injection
Control; Untreated control group	Other: Control; Untreated control group

Outcome Measures

Primary Outcome Measures :

1. Tolerability [ Time Frame: 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)

Secondary Outcome Measures :

1. Immunological [ Time Frame: 6 month ]
   - Titer of antibodies specific for the immunizing peptide, KLH (keyhole limpet hemocyanin; carrier protein), aSynuclein (aSyn), bSyn, aggregated aSyn as assessed by ELlSA, FACS (or equivalent methods)

Other Outcome Measures:

1. Clinical Activity [ Time Frame: 6 month ]
   • Change in motor symptoms (MDS-UPDRS III)
   • Change in non-motor PD symptoms (e.g.; MDS-UPDRS Ia, II, PDQ39, PD NMS, cognition)
   • Change in biological and radiological markers (e.g. CSF alpha synuclein Levels in cerebrospinal fluid)

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 68 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Austria

Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna

Vienna, Austria

Sponsors and Collaborators

Affiris AG

Investigators

• Principal Investigator: Dieter Volc, Prim, Dr.; Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna

More Information

• Responsible Party: Affiris AG
• ClinicalTrials.gov Identifier: NCT02216188 History of Changes
• Other Study ID Numbers: AFFiRiS 008A; 2014-002489-54 ( EudraCT Number )
• First Posted: August 13, 2014
• Last Update Posted: August 17, 2015
• Last Verified: August 2015

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases