Parkinson's DiseasePhase 1AFF008ANCT02216188
Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity
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 AFF008 will be involved and will be receive one 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
- 28 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2014to Aug 2015
- 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 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Vienna, State of Vienna
About this study
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
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.
- Conditions
- Parkinson's Disease
- Being tested
- AFFITOPE® PD01A, Control
- 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
ControlOther
Untreated control group
| Study group | Role | What they receive |
|---|---|---|
| A: AFFITOPE® PD01A + Adjuvant | Experimental | one injection of 15µg AFFITOPE® PD01A/ adjuvanted Receives: Biological: AFFITOPE® PD01A |
| B: AFFITOPE® PD01A + Adjuvant | Experimental | one injection of 75µg AFFITOPE® PD01A/ adjuvanted Receives: Biological: AFFITOPE® PD01A |
| Control | Other | Untreated control group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 month
Secondary outcomes (1)
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)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 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, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216188
- Sponsor's protocol ID
- AFFiRiS 008A
- Other IDs
- 2014-002489-54, 2014
- Acronym
- AFF008A
- Status last verified
- Aug 2015
- First submitted
- 12 Aug 2014
- Last updated
- 17 Aug 2015
- 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 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02216188
- Acronym / sponsor ID
- AFF008A / AFFiRiS 008A
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Affiris AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- First posted
- 13 Aug 2014 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: AFFITOPE® PD01A + Adjuvant | Experimental | Biological: AFFITOPE® PD01Aone injection of 15µg AFFITOPE® PD01A/ adjuvanted |
| B: AFFITOPE® PD01A + Adjuvant | Experimental | Biological: AFFITOPE® PD01Aone injection of 75µg AFFITOPE® PD01A/ adjuvanted |
| Control | Other | Other: ControlUntreated control group |
Who may qualify
- Ages
- 40 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
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 | A: AFFITOPE® PD01A + Adjuvant, B: AFFITOPE® PD01A + Adjuvant |
| ControlUntreated control group | Other | Control |
Primary outcome
Tolerability
Time frame: 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)
1 secondary outcome
Immunological
Time frame: 6 month
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 17 Aug 2015.
- 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, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
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 5 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 17 Aug 2015. 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?
Tolerability (time frame: 6 month). 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 NCT02216188, 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 17 Aug 2015.