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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02216188

Acronym

AFF008A

Enrollment

Registered

2014-08-13

Start date

2014-08-31

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

BIOLOGICALAFFITOPE® PD01A

s.c. injection

OTHERControl

Untreated control group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 68 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Tolerability	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

Measure	Time frame	Description
Immunological	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

Measure	Time frame	Description
Clinical Activity	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)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026