<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02216188</url>
  </required_header>
  <id_info>
    <org_study_id>AFFiRiS 008A</org_study_id>
    <secondary_id>2014-002489-54</secondary_id>
    <nct_id>NCT02216188</nct_id>
  </id_info>
  <brief_title>Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity</brief_title>
  <acronym>AFF008A</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affiris AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Affiris AG</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A&#xD;
      vaccinations in patients with Parkinson's disease. Patients, who have already participated in&#xD;
      AFF008 will be involved and will be receive one boost immunization with AFFITOPE® PD01A. One&#xD;
      study site in Vienna (Austria) will be involved.&#xD;
&#xD;
      In addition, up to 8 patients will be offered participation within an untreated control&#xD;
      group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tolerability</measure>
    <time_frame>6 month</time_frame>
    <description>Occurrence of any Adverse Events (AE)&#xD;
Occurrence of any Serious Adverse Events (SAE)&#xD;
Withdrawal criteria (number of patients who withdraw due to AEs/ reason for withdrawal)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunological</measure>
    <time_frame>6 month</time_frame>
    <description>- 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)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical Activity</measure>
    <time_frame>6 month</time_frame>
    <description>Change in motor symptoms (MDS-UPDRS III)&#xD;
Change in non-motor PD symptoms (e.g.; MDS-UPDRS Ia, II, PDQ39, PD NMS, cognition)&#xD;
Change in biological and radiological markers (e.g. CSF alpha synuclein Levels in cerebrospinal fluid)</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>A: AFFITOPE® PD01A + Adjuvant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one injection of 15µg AFFITOPE® PD01A/ adjuvanted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B: AFFITOPE® PD01A + Adjuvant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one injection of 75µg AFFITOPE® PD01A/ adjuvanted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Untreated control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AFFITOPE® PD01A</intervention_name>
    <description>s.c. injection</description>
    <arm_group_label>A: AFFITOPE® PD01A + Adjuvant</arm_group_label>
    <arm_group_label>B: AFFITOPE® PD01A + Adjuvant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Untreated control group</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prior participation in AFF008 and AFF008E&#xD;
&#xD;
          -  Written informed consent signed and dated by the patient and the caregiver (caregiver&#xD;
             is not mandatory)&#xD;
&#xD;
          -  In the investigator's opinion, does not have visual or auditory impairments that would&#xD;
             reduce the patients' ability to complete study questionnaires or be unable to receive&#xD;
             instructions for these&#xD;
&#xD;
          -  Female patients of childbearing potential are eligible if they use a medically&#xD;
             accepted contraceptive method&#xD;
&#xD;
          -  Stable doses of PD medications for at least 3 months prior to Visit 0 and during the&#xD;
             entire trial period and of all other medications for at least 30 days prior to Visit 1&#xD;
             if considered relevant by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women of childbearing potential without birth control or pregnant women&#xD;
&#xD;
          -  Participation in another clinical trial (except AFF008E) within 3 months before Visit&#xD;
             0&#xD;
&#xD;
          -  History of questionable compliance to visit schedule; patients not expected to&#xD;
             complete the clinical trial&#xD;
&#xD;
          -  Autoimmune disease or allergy to components of the vaccine&#xD;
&#xD;
          -  History of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical&#xD;
             neoplasia)&#xD;
&#xD;
          -  Active infectious disease&#xD;
&#xD;
          -  Immunodeficiency&#xD;
&#xD;
          -  Significant systemic illness or psychiatric illness&#xD;
&#xD;
          -  Alcoholism or substance abuse&#xD;
&#xD;
          -  Prior treatment with experimental immunotherapeutics for PD including IVIG (with the&#xD;
             exception of AFFITOPE ® PD01A), with immunosuppressive drugs or treatment with deep&#xD;
             brain stimulation&#xD;
&#xD;
          -  Venous status rendering it impossible to place an i.v. access&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dieter Volc, Prim, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 14, 2015</last_update_submitted>
  <last_update_submitted_qc>August 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02216188
org study id: AFFiRiS 008A
secondary id: 2014-002489-54
nct id: NCT02216188
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Tolerability
time frame: 6 month
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)
measure: Immunological
time frame: 6 month
description: - 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)
measure: Clinical Activity
time frame: 6 month
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)
arm group label: A: AFFITOPE® PD01A + Adjuvant
arm group type: Experimental
description: one injection of 15µg AFFITOPE® PD01A/ adjuvanted
arm group label: B: AFFITOPE® PD01A + Adjuvant
arm group type: Experimental
description: one injection of 75µg AFFITOPE® PD01A/ adjuvanted
arm group label: Control
arm group type: Other
description: Untreated control group
intervention type: Biological
intervention name: AFFITOPE® PD01A
description: s.c. injection
arm group label: A: AFFITOPE® PD01A + Adjuvant
arm group label: B: AFFITOPE® PD01A + Adjuvant
intervention type: Other
intervention name: Control
description: Untreated control group
arm group label: Control
criteria: 
gender: All
minimum age: 40 Years
maximum age: 68 Years
healthy volunteers: No
last name: Dieter Volc, Prim, Dr.
role: Principal Investigator
affiliation: Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Parkinson Disease