Vaccination with a CDR2 BV6S2/6S5 peptide in adjuvant induces peptide-specific T-cell responses in patients with multiple sclerosis

Earlier studies from several groups including ours have documented that patients with multiple sclerosis (MS) have over‐expression of activated T‐cells from specific TCR Vβ families, including BV6S2/S5 (Kotzin et al. [1991] Proc. Natl. Acad. Sci. USA 88:9161–9165; Gold et al. [1997] J. Neuroimmunol. 76:29–38). It has also been established in the rat EAE model that peptide vaccines to the over‐expressed Vβ 8.2 TCR can prevent MBP induced disease (Vandenbark et al. [1989] Nature 341:541–544). In the current clinical study, 10 patients were vaccinated with 300 μg of BV6S2/6S5 peptide emulsified in incomplete Freund's adjuvant (IFA) and monitored for safety and immunogenicity in a 48‐week multicenter, open‐label trial. The peptide vaccine was well tolerated and no serious adverse events were observed. Vaccinations induced cell‐mediated immunity to the immunizing peptide in eight of 10 patients as demonstrated by lymphocyte proliferation assay (LPA) and delayed‐type hypersensitivity (DTH) skin test responses. In summary, these results demonstrate that immunization with TCR BV6S2/6S5 peptide vaccine in MS patients is safe and immunogenic, and supports a larger double‐blind placebo controlled trial to determine the clinical efficacy of this approach. J. Neurosci. Res. 64:298–301, 2001. © 2001 Wiley‐Liss, Inc.