AFF008E: Observational Phase 1b Follow-up Extension Study for Patients With Parkinson's Disease After Immunization With AFFITOPE® PD01A

A

Affiris

Status

Completed

Conditions

Parkinson's Disease

Study type

Observational

Funder types

Industry

Identifiers

NCT01885494
2013-001774-20 (EudraCT Number)
AFF008E

Details and patient eligibility

About

AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been applied during AFF008 with regard to safety as well as immunological-, radiological and clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied. Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at the occasion of 4 quarterly visits. This is offered to patients who received PD01A vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will ensure standardized and controlled management of individuals who have received PD01A as part of AFF008, the Phase I study analyzing for the first time in humans this first in class candidate.

Enrollment

30 patients

Sex

All

Ages

41 to 66 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Written informed consent signed and dated by the patient
  • Participation in AFF008

Exclusion criteria

  • History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
  • Participation in the active treatment phase of another clinical trial except AFF008 within 13 weeks before Visit 1 and for the whole study duration

Trial design

30 participants in 3 patient groups

15µg AFFITOPE® PD01A
Description:
Patients With Parkinson's Disease vaccinated with 4 injections of 15µg AFFITOPE® PD01A adsorbed to adjuvant during AFF008
75µg AFFITOPE® PD01A
Description:
Patients With Parkinson's Disease vaccinated with 4 injections of 75µg AFFITOPE® PD01A adsorbed to adjuvant during AFF008
Control group
Description:
Untreated control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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