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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

AFFITOPE® PD01A

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, 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

Sites / Locations

Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AFFITOPE® PD01A + Adjuvant

Control

Arm Description

one injection of 75µg AFFITOPE® PD01A/adjuvanted

Untreated control group

Outcomes

Primary Outcome Measures

Occurrence of any Serious Adverse Events (SAE) that are related to the study drug

Number of patients who withdraw due to Adverse Events (AEs)

The withdrawal criteria (continuation decision) in regards to the number of patients who withdraw due to AEs as well as the reason for withdrawal will be evaluated.

Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination

Secondary Outcome Measures

Immunological activity of AFFITOPE® vaccine PD01A

Titer of vaccination induced antibodies directed towards vaccine components and the target (native aSyn) assessed by ELISA (or equivalent method)

Full Information

NCT ID

NCT02618941

First Posted

November 25, 2015

Last Updated

June 2, 2017

Sponsor

Affiris AG

1. Study Identification

Unique Protocol Identification Number

NCT02618941

Brief Title

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

Official Title

Phase IB Follow-up, Controlled, Parallel Group, Single-center Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological and Clinical Activity in Patients Who Have Participated in the AFF008 Program

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

February 2, 2016 (Actual)

Primary Completion Date

February 28, 2017 (Actual)

Study Completion Date

February 28, 2017 (Actual)

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 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.

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

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AFFITOPE® PD01A + Adjuvant

Arm Type

Experimental

Arm Description

one injection of 75µg AFFITOPE® PD01A/adjuvanted

Arm Title

Control

Arm Type

No Intervention

Arm Description

Untreated control group

Intervention Type

Biological

Intervention Name(s)

AFFITOPE® PD01A

Intervention Description

s.c. injection

Primary Outcome Measure Information:

Title

Occurrence of any Serious Adverse Events (SAE) that are related to the study drug

Time Frame

12 months

Title

Number of patients who withdraw due to Adverse Events (AEs)

Description

The withdrawal criteria (continuation decision) in regards to the number of patients who withdraw due to AEs as well as the reason for withdrawal will be evaluated.

Time Frame

12 months

Title

Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Immunological activity of AFFITOPE® vaccine PD01A

Description

Titer of vaccination induced antibodies directed towards vaccine components and the target (native aSyn) assessed by ELISA (or equivalent method)

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

MDS-UPDRS Ia, II, III

Description

Change in motor/non-motor symptoms over time

Time Frame

12 months

Title

PDQ39

Description

Change in non-motor PD symptoms over time

Time Frame

12 months

Title

PD NMS

Description

Change in non-motor PD symptoms over time

Time Frame

12 months

Title

Cognitive scales

Description

Change in non-motor PD symptoms over time

Time Frame

12 months

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, 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dieter Volc, Prim. Dr.

Organizational Affiliation

Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

Official's Role

Principal Investigator

Facility Information:

Facility Name

Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

City

Vienna

ZIP/Postal Code

1080

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 a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)

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