Parkinson's DiseasePhase 1NCT02618941
Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)
A Phase 1 study testing AFFITOPE® PD01A in people with Parkinson's Disease, run by Affiris AG at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 68 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- AFFITOPE® PD01A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteAustria
- Study dates
- 2 Feb 2016to 28 Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
Vienna, 1080
About this study
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
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.
- Conditions
- Parkinson's Disease
- Being tested
- AFFITOPE® PD01A
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFFITOPE® PD01ABiological
s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| AFFITOPE® PD01A + Adjuvant | Experimental | one injection of 75µg AFFITOPE® PD01A/adjuvanted Receives: Biological: AFFITOPE® PD01A |
| Control | No intervention | Untreated control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any Serious Adverse Events (SAE) that are related to the study drug
Measured: 12 months
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.
Measured: 12 months
Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination
Measured: 12 months
Secondary outcomes (1)
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start2 Feb 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiris AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dieter Volc, Prim. Dr., Principal investigator, Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618941
- Sponsor's protocol ID
- AFFiRiS 008AA
- Other IDs
- 2015-004854-16, 2015
- Status last verified
- Jun 2017
- First submitted
- 25 Nov 2015
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30741694
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02618941
- Acronym / sponsor ID
- AFFiRiS 008AA
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Affiris AGIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFFITOPE® PD01A + Adjuvant | Experimental | Biological: AFFITOPE® PD01Aone injection of 75µg AFFITOPE® PD01A/adjuvanted |
| Control | No intervention | –Untreated control group |
Who may qualify
- Ages
- 40 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFFITOPE® PD01As.c. injection | Biological | AFFITOPE® PD01A + Adjuvant |
Primary outcome
Occurrence of any Serious Adverse Events (SAE) that are related to the study drug
Time frame: 12 months
Number of patients who withdraw due to Adverse Events (AEs)
Time frame: 12 months
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
Time frame: 12 months
1 secondary outcome
Immunological activity of AFFITOPE® vaccine PD01A
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Derived from this study: PubMed 30741694McFarthing 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Volc, Prim. Dr. principal investigator
Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFFITOPE® PD01A in people with Parkinson's Disease, run by Affiris AG at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of any Serious Adverse Events (SAE) that are related to the study drug (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02618941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017; AzTrials last refreshed its copy on 29 Oct 2026.