A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for Multiple Sclerosis

Phase 1

Conditions: Multiple Sclerosis

Registration Number: EUCTR2006-003384-30-SK

Lead Sponsor: The Immune Response Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1.Subjects between 18 and 50 years of age, inclusive.
2.Definite MS by the revised McDonald criteria (2005) (Appendix A), with a relapsing remitting course.
3.Expanded Disability Status Scale (EDSS) score = 5.5 (Appendix B).
4.Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse in the preceding 12 months prior to screening.
5.Laboratory values within the following limits:
•Creatinine < 1.5 x high normal
•Hemoglobin > 9.5 mg/dL
•SGOT/SGPT < 2.5 x high normal
•Platelets > 75,000/mm3
6.Must use effective means of contraception.
7.Must give adequate informed consent and abide by the requirements of the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant or lactating female.
2.Clinical relapse or corticosteroid treatment within 30 days prior to screening.
3.Prior use of TCR peptides, T cell vaccines, natalizumab, cladribine, or mitoxantrone.
4.Use of beta interferon, glatiramer acetate, methotrexate, azothioprine, cyclophosphamide, any immunostimulatory, immunosuppressive or immunomodulatory therapy within 90 days of screening.
5.Receipt of any immunizations within 30 days prior to Week 0.
6.Use of any statin class medications within 30 days prior to screening.
7.Any other investigational drug within 30 days prior to screening or planned use during study.
8.Active malignancy (other than squamous or basal cell skin cancer or cancer in situ of the cervix).
9.Any medical condition, which in the judgment of the investigator would put the subject at unacceptable risk for participation in the study or that would confound the results of the study.
10.Active substance abuse.