基因重组乙型肝炎疫苗的免疫效果研究

目的：评价基因重组乙型肝炎（乙肝）疫苗对人群的免疫效果。方法：C地195名新生儿、191名中学生及219名不同HBV感染接种疫苗,进行效果观察,并比较重组酵母来源和血源来源的2种不同检测乙型表面抗体的放射免疫分析方法试剂。结果：新生儿免疫后,抗－HBs阳性转率均达到85％以上,但中华地鼠卵巢细胞基因重组乙肝疫苗不论是在抗体阳转率还是在抗体滴度上效果都优于酵母乙肝疫苗,中学生免疫后,抗－HBs阳转率达70％以上,免疫后2年时10μg－5μg－5μg剂量组的免疫效果要优于5μg－5μg－5μg组。对HBV不同感染免疫后,可使51．14％的感染抗－HBs阳转或抗－HBs滴度上升,重组酵母来源试剂检测抗－HBs的阳转率（81．42％）,比血源来源试剂检测（73．33％）可提高近10％。结论：基因重组乙肝疫苗10μg－5μg－5μg剂量为宜。在监测人群免疫后抗－HBs时,应选用相应抗原制备的试剂检测相应抗体,以提高检测的敏感性。     

Phase II study of niraparib in recurrent or persistent rare fraction of gynecologic malignancies with homologous recombination deficiency (JGOG2052)

BackgroundPoly (adenosine diphosphate)-ribose polymerase (PARP) inhibitors for tumors with homologous recombination deficiency (HRD), including pathogenic mutations in BRCA1/2, have been developed. Genomic analysis revealed that about 20% of uterine leiomyosarcoma (uLMS) have HRD, including 7.5%–10% of BRCA1/2 alterations and 4%–6% of carcinomas of the uterine corpus, and 2.5%–4% of the uterine cervix have alterations of BRCA1/2. Preclinical and clinical case reports suggest that PARP inhibitors may be effective against those targets. The Japanese Gynecologic Oncology Group (JGOG) is now planning to conduct a new investigator-initiated clinical trial, JGOG2052.MethodsJGOG2052 is a single-arm, open-label, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of niraparib monotherapy for a recurrent or persistent rare fraction of gynecologic malignancies with BRCA1/2 mutations except for ovarian cancers. We will independently consider the effect of niraparib for uLMS or other gynecologic malignancies with BRCA1/2 mutations (cohort A, C) and HRD positive uLMS without BRCA1/2 mutations (cohort B). Participants must have 1–3 lines of previous chemotherapy and at least one measurable lesion according to RECIST (v.1.1). Niraparib will be orally administered once a day until lesion exacerbation or unacceptable adverse events occur. Efficacy will be evaluated by imaging through an additional computed tomography scan every 8 weeks. Safety will be measured weekly in cycle 1 and every 4 weeks after cycle 2 by blood tests and physical examinations. The sample size is 16–20 in each of cohort A and B, and 31 in cohort C. Primary endpoint is the objective response rate.Trial RegistrationJapan Primary Registries Network (JPRN) Identifier: jRCT2031210264