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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

AFFITOPE® PD01A

Control

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

40 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

A: AFFITOPE® PD01A + Adjuvant

B: AFFITOPE® PD01A + Adjuvant

Control

Arm Description

one injection of 15µg AFFITOPE® PD01A/ adjuvanted

one injection of 75µg AFFITOPE® PD01A/ adjuvanted

Untreated control group

Outcomes

Primary Outcome Measures

Tolerability

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

Immunological

- 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)

Full Information

NCT ID

NCT02216188

First Posted

August 12, 2014

Last Updated

August 14, 2015

Sponsor

Affiris AG

1. Study Identification

Unique Protocol Identification Number

NCT02216188

Brief Title

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

Acronym

AFF008A

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 Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Affiris AG

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: AFFITOPE® PD01A + Adjuvant

Arm Type

Experimental

Arm Description

one injection of 15µg AFFITOPE® PD01A/ adjuvanted

Arm Title

B: AFFITOPE® PD01A + Adjuvant

Arm Type

Experimental

Arm Description

one injection of 75µg AFFITOPE® PD01A/ adjuvanted

Arm Title

Control

Arm Type

Other

Arm Description

Untreated control group

Intervention Type

Biological

Intervention Name(s)

AFFITOPE® PD01A

Intervention Description

s.c. injection

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

Untreated control group

Primary Outcome Measure Information:

Title

Tolerability

Description

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)

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Immunological

Description

Time Frame

6 month

Other Pre-specified Outcome Measures:

Title

Clinical Activity

Description

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)

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dieter Volc, Prim, Dr.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Vienna

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

30741694

Citation

McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004. No abstract available.

Results Reference

derived

Learn more about this trial

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

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