生物谷报道：加拿大研究人员在最新一期美国《神经病学文献》月刊上发表研究报告说，有种ＤＮＡ疫苗能帮助治疗多发性硬化症。
据路透社１３日报道，加拿大蒙特利尔神经学院神经免疫学专家阿米特·巴尔－奥尔等人对３０名多发性硬化症患者使用一种名叫ＢＨＴ－３００９的ＤＮＡ疫苗进行了为期两年的治疗。他们将ＢＨＴ－３００９疫苗注入患者体内，使患者体内生成能保护大脑等处神经细胞的髓鞘碱性蛋白质，从而促成对病人有利的抗原免疫变化。
初步研究结果表明，这种ＤＮＡ疫苗对病人无害，接受疫苗注射的多发性硬化症患者在治疗期间复发几率减少，脑部损伤也比对照组患者小得多。
路透社报道说，这种疫苗由美国加州一家生物科技公司生产，目前仍处于实验阶段。加拿大研究人员目前已扩大实验规模，为２９０名多发性硬化症患者注射这种疫苗，以进一步了解疫苗的效果。
多发性硬化症是一种自体免疫性疾病，症状包括视力模糊、身体失去平衡、协调能力差、极度疲劳、瘫痪和失明等。
原始出处:
Arch Neurol, Aug 2007; doi:10.1001/archneur.64.10.nct70002
Early Release Article, posted August 13, 2007
Induction of Antigen-Specific Tolerance in Multiple Sclerosis After Immunization With DNA Encoding Myelin Basic Protein in a Randomized, Placebo-Controlled Phase 1/2 Trial
Amit Bar-Or, MD; Timothy Vollmer, MD; Jack Antel, MD; Douglas L. Arnold, MD; Caroline Anita Bodner, MSc; Denise Campagnolo, MD; Jill Gianettoni, BS; Farzaneh Jalili, BSc; Norman Kachuck, MD; Yves Lapierre, MD; Masaaki Niino, MD, PhD; Joel Oger, MD; Mary Price, BS; Susan Rhodes, MS; William H. Robinson, MD, PhD; Fu-Dong Shi, MD, PhD; Paul J. Utz, MD; Frank Valone, MD; Leslie Weiner, MD; Lawrence Steinman, MD; Hideki Garren, MD, PhD
Arch Neurol. 2007;64:(doi:10.1001/archneur.64.10.nct70002).
Objective To assess safety and immune modulation by BHT-3009, a tolerizing DNA vaccine encoding full-length human myelin basic protein, in patients with multiple sclerosis (MS).
Design The study was a randomized, double-blind, placebo-controlled trial. Subjects receiving placebo were crossed over into an active arm after treatment unblinding.
Setting The trial was conducted at 4 academic institutions within North America.
Patients Thirty patients with relapsing-remitting or secondary progressive MS who were not taking any other disease-modifying drugs were enrolled in the trial. Further, the patients were required to have either 1 to 5 gadolinium-enhancing lesions on screening brain magnetic resonance imaging (MRI), a relapse in the previous 2 years, or disease worsening in the previous 2 years.
Interventions BHT-3009 was administered as intramuscular injections at weeks 1, 3, 5, and 9 after randomization into the trial, with or without 80 mg of daily oral atorvastatin calcium in combination. Three dose levels of BHT-3009 were tested (0.5 mg, 1.5 mg, and 3 mg).
Main Outcome Measures The primary outcome measures were safety and tolerability of BHT-3009. Secondary outcome measures included the number and volume of gadolinium-enhanced lesions on MRI, relapses, and analysis of antigen-specific immune responses.
Results BHT-3009 was safe and well tolerated, provided favorable trends on brain MRI, and produced beneficial antigen-specific immune changes. These immune changes consisted of a marked decrease in proliferation of interferon-–producing, myelin-reactive CD4+ T cells from peripheral blood and a reduction in titers of myelin-specific autoantibodies from cerebral spinal fluid as assessed by protein microarrays. We did not observe a substantial benefit of the atorvastatin combination compared with BHT-3009 alone.
Conclusion In patients with MS, BHT-3009 is safe and induces antigen-specific immune tolerance with concordant reduction of inflammatory lesions on brain MRI.
Trial Registration clinicaltrials.gov Identifier: NCT00103974.
Author Affiliations: Montreal Neurological Institute (Drs Bar-Or, Antel, Lapierre, and Niino and Mss Bodner and Jalili) and NeuroRx Research (Dr Arnold), Montreal, Quebec, Canada; Barrow Neurological Institute, Phoenix, Arizona (Drs Vollmer, Campagnolo, and Shi and Mss Price and Rhodes); Bayhill Therapeutics, Inc, Palo Alto, California (Ms Gianettoni and Drs Valone and Garren); University of Southern California, Los Angeles (Drs Kachuck and Weiner); University of British Columbia, Vancouver, British Columbia, Canada (Dr Oger); and Stanford University, Stanford, California (Drs Robinson, Utz, Steinman, and Garren).
