None listed
Conditions
Brief summary
This study aims to demonstrate that an immunotherapy made from a patient's own blood cells, (known as Rheumavax) can safely modify (reduce or desensitize) the body’s immune response to a specific rheumatoid arthritis antigen.
Interventions
Autologous modified dendritic cells (DC) pulsed with a mixture of four citrullinated peptide antigens (cit-vimentin
447-455, cit-fibrinogen beta chain 433-441, cit-fibrinogen alpha chain 717-725, cit-collagen type II 1237-1249) designated “Rheumavax”, will be administered intradermally once to each group of 9 rheumatoid arthritis patients on usual disease modifying drugs in 2 progressive vaccine dose levels (total of 18 vaccinated subjects) in an escalating dose regimen.
Group 1: 1 million DC on
Autologous modified dendritic cells (DC) pulsed with a mixture of four citrullinated peptide antigens (cit-vimentin 447-455, cit-fibrinogen beta chain 433-441, cit-fibrinogen alpha chain 717-725, cit-collagen type II 1237-1249) designated “Rheumavax”, will be administered intradermally once to each group of 9 rheumatoid arthritis patients on usual disease modifying drugs in 2 progressive vaccine dose levels (total of 18 vaccinated subjects) in an escalating dose regimen. Group 1: 1 million DC on day 1 of study Group 2: 5 million DC on day 1 of study
Sponsors
Uniquest
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years 2. Either sex. It is anticipated that the male: female ratio will be approximately 4:6 for due to the female preponderance with Rheumatoid Arthritis (RA) 3. Subjects who are willing and able to participate in the study for 6 months and from whom written informed consent has been obtained. 4. Diagnosis of definite RA by American College of Rheumatology criteria with symptoms for at least 3 months 5. In female patients of child-bearing potential, safe contraceptive measures must be used 6. Blood glucose, routine hematology, creatinine, bilirubin and liver function tests within normal limits at entry 7. Must be receiving <10mg/day of prednisone as part of their drug treatment. Patients must have had RA diagnosed and treated by a rheumatologist. Acceptable disease modifying treatment (either as monotherapy or combination therapy) includes methotrexate, salazopyrin, hydroxychloroquine, gold injections, leflunomide, or biologics (etanercept, infliximab, humira or anakinra). Anti-inflammatory medications and local corticosteroid injections are also permissible. 8. Demonstrated anti-CCP antibodies. Rheumatoid factor positive or negative. human leukocyte antigen (HLA)-DR shared epitope positive (HLA-DRB1*0401, 0404, 0405, 0408, 01, 1001, 1401, 1402, 09)
Exclusion criteria
1. Any malignancy 2. History or family history of atopy: eczema, asthma, nasal polyps or allergic rhinitis 3. Positive allergen reactivity (RAST) test 4. Serious infection within the past 28 days that has not adequately responded to therapy 5. Receipt of any live attenuated vaccines within 4 weeks of study entry. 6. Major surgery within the past 28 days 7. Significant cardiovascular, renal, liver, neurological or skin disease 8. Females who are pregnant or lactating or who expect to become pregnant within the duration of the study, or who refuse to take contraceptives for the duration of the study 9. Positive serology for Human Immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV) 10. >10 mg prednisone daily 11. Treatment with cytotoxic or immunomodulatory therapies such as radiotherapy, cyclophosphamide, mycophenolate, tacrolimus, psoralen ultraviolet therapy (PUVA), etretinate, cyclosporine, or azathioprine. 12. History of drug abuse that would interfere with the ability to comply with the study protocol. 13. Any condition judged by the physician to cause this study to be detrimental to the patient.
Outcome results
None listed