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PubMed2002

Current protocol of a research phase I clinical trial of full-length dystrophin plasmid DNA in Duchenne/Becker muscular dystrophies. Part II: clinical protocol.

A phase I open clinical study on gene therapy in Duchenne and Becker muscular dystrophy, without direct individual benefit for the patient, is being performed at the Pitié-Salpêtrière Hospital, Paris. The aims of this project are: (a) to determine the tolerance and the safety of the intramuscular administration of dystrophin cDNA and (b) to study the quality of the gene transfer in vivo in human patients affected by Duchenne and Becker muscular dystrophy. This clinical trial is conducted sequentially and includes three cohorts of three patients each. Patients must be at least 15 years of age. Diagnosis of Duchenne and Becker muscular dystrophy was confirmed by molecular analysis of the dystrophin gene and for each patient the abnormal expression of dystrophin was confirmed, in skeletal muscle, with antibodies directed against the deleted part of the dystrophin. This phase I study is scheduled to be completed by the end of 2002.

Adult↗

PubMed2000

Prevention of group B streptococcus early-onset neonatal sepsis: comparison of the Center for Disease Control and prevention screening-based protocol to a risk-based protocol in infants at greater than 37 weeks' gestation.

OBJECTIVE: To compare the Center for Disease Control consensus guidelines' screening-based strategy to a risk-based strategy as regards the incidence of early-onset group B streptococcus (GBS) infection among term infants. STUDY DESIGN: A cohort of university hospital prenatal clinic mother-infant pairs who were screened for GBS at 35 to 37 weeks' gestation were compared to a matched control group of unscreened mother-infant pairs from the outreach satellite prenatal clinics who delivered at the same institution during the same time period. GBS screening was carried out with rectovaginal cultures plated on selective media. GBS-positive women received antimicrobial prophylaxis in labor whereas women of unknown GBS status were only treated intrapartum if they had a risk factor for GBS infection. Principal outcome variables included incidence of cases of neonatal early-onset GBS sepsis (blood, urine, or cerebrospinal fluid positive for GBS), incidence of cases of strongly suspected GBS sepsis (culture negative), and incidence of neonatal sepsis with non-GBS organisms. RESULTS: There were 3164 screened mother-infant pairs who were compared to 2684 unscreened pairs. The incidence of GBS carriage was 13.3%. A random sample of 420 screened women were compared to a matched sample of 407 women of unknown GBS carrier status for characterization of demographics and risk factors. No cases of documented GBS sepsis occurred in the infants of the screened women, but four cases occurred among the infants of the women who did not undergo screening (incidence 1.5/1000) (p = 0.04), only one of whom had a risk factor for GBS infection. Cases of suspected but culture negative sepsis were not more common in the screened population when compared to the unscreened. There was one case of Escherichia coli sepsis in an infant of a mother in the unscreened group. CONCLUSIONS: GBS screening at 35 to 37 weeks, with intrapartum antimicrobial prophylaxis of carriers, decreased the incidence of neonatal early-onset GBS sepsis and appears to have advantages over treatment based on risk factors alone in term infants.

Clinical Protocols↗

PubMed1995

A phase I trial of B7-transfected or parental lethally irradiated allogeneic melanoma cell lines to induce cell-mediated immunity against tumor-associated antigen presented by HLA-A2 or HLA-A1 in patients with stage IV melanoma. NCI protocol T93-0161. BRMP protocol 9401.

T cell lines generated by primary in vitro stimulation with B7-expressing HLA-A2+ melanoma cells lyse HLA-A2+ melanomas, but not non-melanomas that are HLA-A2+. Other data have demonstrated lack of response of these T cell lines against non-HLA-A2 melanomas. These concepts are verified by data from MALME MEL, which is killed, and MALME FIB, which is not. In no case was lysis directed at targets expressing potential allo-antigens (except for HLA-A2+ melanomas). A19 and Aw33 have not been excluded as possible allo-targets (but no data suggests they are). In total, it appears that much of the lytic activity observed in the two T cell lines is directed against HLA-A2-restricted, melanoma-specific antigens.

Adult↗

PubMed1999