Immunoregulation by Controlled Parasite Exposure in Multiple Sclerosis
Immunoregulation by Controlled Parasite Exposure in Multiple Sclerosis.
What it found
The trial ended early for another reason (see below).
Reason given: superceded by another similar study
What was tested
Treatment tested
- Live Hookworm Larvae
Placebo
- Histamine
What it measured
Main measures
Primary outcome measure is an increase in the percentage from total CD4+ T cells of CD4+CD25+foxp3+ cells.
End of study
Immune response
Other measures (4)
The expression of foxp3 mRNA from peripheral blood mononuclear cells (PBMC).
End of study
Immune responseThe percentage from total PBMC of NK and NKT cells (CD3-CD56+ and CD3+CD56+ respectively).
End of study
Immune responseThe percentage from total CD3+ T cells of Tr1 cells (CD3+IL10+ T cells).
End of study
Immune responseThe percentage from total PBMC of B regulatory cells (CD20+IL-10+).
End of study
Immune response
Who could take part
Relapsing and progressive · 18 to 60 · EDSS 0 to 5.5
Show the full criteria
Inclusion criteria
1. Patients with documented multiple sclerosis relapsing remitting or secondary progressive with relapses, according to McDonald's criteria, and an MRI scan consistent with MS according to Fazekas criteria 2. Patients with at least 1 relapse in the last 12 months 3. Patients with EDSS score in the range of 0 to 5.5 at the baseline visit 4. Patients of both genders, age >18 years and \< 60 years 5. Women of child bearing potential, (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study. 6. Be able and willing to comply with study visits and procedures per protocol. 7. Understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
Exclusion criteria
No populations at risk of severe illness or death will be included in this study 1. Life expectancy \< 6 months. 2. Patient is \< 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ. 3. Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) 4. Patients with severe and/or uncontrolled medical condition. 5. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. 6. Anaemia (Hb \<10 g/dL for females, \<11 g/dL for males) 7. Prior or present evidence of parasitic infection; prior treatment with anti-helminthic drugs 8. Patient with serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol 9. History of poor compliance or history of drug/alcohol abuse, or excessive alcohol consumption that would interfere with the ability to comply with the study protocol, 10. Severe asthma, allergy, other autoimmune disease or any condition that the physician judges could be detrimental to subjects participating in this study; including deviations deemed clinically important from normal clinical laboratory Previous treatment 1. Treatment with interferon or glatiramer acetate or immunosuppressive drugs within 26 weeks prior to baseline 2. Treatment with bone marrow transplantation, total lymphoid irradiation, monoclonal antibodies, umbilical cord stem cells, AIMSPRO at any time prior to baseline 3. Treatment with corticosteroids or ACTH within 4 weeks prior to baseline 4. Treatment with any investigational agent within 12 weeks prior to baseline
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The aim of the study is to determine whether controlled infection with a clinically safe number of larvae of hookworm results in an immune response that is protective in relapsing MS.
Papers
Background
Bach JF. The effect of infections on susceptibility to autoimmune and allergic diseases. N Engl J Med. 2002 Sep 19;347(12):911-20. doi: 10.1056/NEJMra020100. No abstract available.Background
Edwards LJ, Constantinescu CS. A prospective study of conditions associated with multiple sclerosis in a cohort of 658 consecutive outpatients attending a multiple sclerosis clinic. Mult Scler. 2004 Oct;10(5):575-81. doi: 10.1191/1352458504ms1087oa.Background
Steinman L. A brief history of T(H)17, the first major revision in the T(H)1/T(H)2 hypothesis of T cell-mediated tissue damage. Nat Med. 2007 Feb;13(2):139-45. doi: 10.1038/nm1551.Background
Viglietta V, Baecher-Allan C, Weiner HL, Hafler DA. Loss of functional suppression by CD4+CD25+ regulatory T cells in patients with multiple sclerosis. J Exp Med. 2004 Apr 5;199(7):971-9. doi: 10.1084/jem.20031579.Background
Fleming JO, Cook TD. Multiple sclerosis and the hygiene hypothesis. Neurology. 2006 Dec 12;67(11):2085-6. doi: 10.1212/01.wnl.0000247663.40297.2d. No abstract available.Background
Correale J, Farez M. Association between parasite infection and immune responses in multiple sclerosis. Ann Neurol. 2007 Feb;61(2):97-108. doi: 10.1002/ana.21067.Background
Sewell D, Qing Z, Reinke E, Elliot D, Weinstock J, Sandor M, Fabry Z. Immunomodulation of experimental autoimmune encephalomyelitis by helminth ova immunization. Int Immunol. 2003 Jan;15(1):59-69. doi: 10.1093/intimm/dxg012.Background
Mortimer K, Brown A, Feary J, Jagger C, Lewis S, Antoniak M, Pritchard D, Britton J. Dose-ranging study for trials of therapeutic infection with Necator americanus in humans. Am J Trop Med Hyg. 2006 Nov;75(5):914-20.Background
Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.Background
Hotez PJ, Pritchard DI. Hookworm infection. Sci Am. 1995 Jun;272(6):68-74. doi: 10.1038/scientificamerican0695-68.
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History
Started
Feb 2008
Main results due
May 2008
Finished
May 2008