Status:
COMPLETED
Study Assessing Safety and Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early MSA
Lead Sponsor:
Affiris AG
Collaborating Sponsors:
University Hospital, Bordeaux
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Multiple System Atrophy
Neurodegenerative Diseases
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
Brief Summary
This is a randomized controlled parallel Group phase I study to investigate the safety and immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE® PD03A, given to patien...
Eligibility Criteria
Inclusion
- Possible or probably MSA diagnosis (MSA-P or MSA-C) according to Gilman 2008 consensus criteria
- Onset of MSA symptoms less than 4 years
- Participants with an anticipated survival of at least 3 years in the opinion of the PI
- Written informed consent obtained prior to study entry
- MSA patient \> 30 and \< 75 years of age at time of study entry
- Female patients of childbearing potential using a medically accepted contraceptive method
- Stable medication for MSA symptoms (Levodopa, Dopamine agonists, Midodrine, Fludrocortisone, monoamine oxidase-B and Catechol-O-methyltransferase inhibitors; Antidepressants, Laxatives, NSAIDs or paracetamol as basic medication for pain in the musculoskeletal system)
Exclusion
- Pregnant or lactating women
- Sexually active women of childbearing potential not using a medically accepted birth control method
- Patients with dementia (MOCA at Screening \< 21)
- Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1
- Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2
- Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7
- History or evidence of any other central nervous system disorder like stroke, angioma and other relevant neurological diseases
- History of malignancy other than skin cancer during the last 5 years (if considered to be cured, patient might be included)
- Active or passive vaccination 4 weeks before the first vaccination on Day 0 and during the main study period ending on Day 280. Emergency vaccinations are acceptable
- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the entire study period
- Subjects participating or have participated in another interventional clinical trial within 60 days prior to baseline
- Blood donation within 4 weeks prior to first vaccination.
- History of autoimmune diseases, severe hypersensitivity reactions and anaphylaxis, allergic bronchial asthma and severe allergic rhinoconjunctivitis
- Known hypersensitivity or allergic reaction to one of the components of the vaccine
- A family history of congenital or hereditary immunodeficiency
- Administration of chronic (defined as more than 14 days) immunosuppressant or other immune-modifying drugs within six months before first vaccination and during the entire study period. For corticosteroids like prednisone or equivalent ≥ 0.05 mg/kg/day. Topical and inhaled steroids are allowed
- Intake of non steroidal anti-inflammatory drugs (NSAIDs) or paracetamol more than the basic medication for pain in the musculoskeletal system within three days prior to a vaccination with AFFITOPE® PD01A or AFFITOPE® PD03A or Placebo
- If a patient shows an acute febrile infection (≥ 37.8° Celsius) on the day of vaccination, administration of Investigational Medicinal Product (IMP) should be postponed until resolution of the infection
- Infection with the human immunodeficiency virus (HIV, a negative test result within 30 days before screening is acceptable), Hepatitis B (HBsAg) or Hepatitis C
- Significant systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure and/or other deficiencies), if considered relevant by the investigator
- Venous status rendering it impossible to place an i.v. access
- Contraindications for MRI and lumbar puncture
- Not able to understand and comply with protocol requirements, instructions, protocol-stated restrictions
- Unwilling to provide informed consent. Exceptions for patients who are physically not able to provide written informed consent (e.g. legal representative, consent via voce with witness)
Key Trial Info
Start Date :
December 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02270489
Start Date
December 11 2014
End Date
April 18 2017
Last Update
June 5 2017
Active Locations (2)
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1
University Hospital Bordeaux (Pellegrin Hospital)
Bordeaux, France, 33076
2
University Hospital Toulouse
Toulouse, France, 31059