HTLV-1 infection in Japan, Hawaii, and California: the effect of immigration from endemic southwestern Japan

a.受试者：美国大陆：red （SF地区）研究的受试者入学已经开始。在15名符合条件的红魔女性中，目前有5名女性已经注册，另有2名女性拒绝注册。红十字会所属的三家红血库的红人登记工作因需要获得中央红十字会办公室的人体受试者批准而推迟。然而，red研究指导委员会已经批准了女性的登记，NIH项目官员George Nemo博士已经批准了通过red机制登记的受试者。在其他红十字会血液中心共发现了8名其他受试者。美国红十字会在登记前需要得到红十字会人类受试者委员会的另一项批准。这项申请是在1994年1月初提出的，但是他们的委员会只是不定期开会，尚未得到最后核可。我们期望在2月底之前获得批准。夏威夷：由于在夏威夷站点建立研究基础设施的后勤工作，我们在夏威夷站点开始登记时遇到了延迟，因为该站点远离日本和美国的主要调查员。然而，夏威夷血库新任医学主任玛丽·弗林博士被任命为这项研究的主要负责人，这极大地促进了这些问题的出现。弗林博士负责初步安排，包括建立预算安排，并指定最近从血库解雇的熟练的研究技术人员进行研究登记。该研究方案目前正在接受夏威夷血库人类受试者审查委员会的审查。一旦这项审查完成，我们打算开始受试者的登记。目前，夏威夷符合研究条件的HTLV-1感染日裔美国妇女的最新总数为35人。长崎：已获得长崎大学人权委员会的批准。利用长崎的ATL预防方案（APP）， 50名计划生育的妇女中约有25人已经登记。根据红细胞溶解方案处理血液样本的程序已经在长崎和旧金山建立并实施。按照计划，其他美国研究机构将把它们的样本通过连夜邮寄到加州大学旧金山分校墨菲博士的实验室，保存白细胞颗粒和血浆样本。另外，HTLV-1标本的定量PCR初步研究已经完成，并显示HTLV-1病毒载量与HTLV-1抗体滴度之间存在相关性。少

a. SubjectsMain land US : Enrollment of subject from the REDS (SF area) study has begun. Of the 15 eligible REDS women, five have been enrolled thus far and 2 additional women have refused enrollment. The REDS enrollment at the three REDS blood banks which are RED Cross affiliated has been delayed by the necessity to obtain Human Subjects' approval by the central Red Cross Office. However, the REDS study Steering Committee has given approval to enrollment of the women, and the NIH project officer, George Nemo, Ph.D. has approved enrollment of subjects through the REDS mechanism. A total of eight other subjects has been identified at other Red Cross blood centers. The American Red Cross requires another approval by the central Red Cross Human Subjects' Committee before enrolling. This application was submitted in early January 1994, however, their committee meets only irregularly and a final approval has not yet been obtained. We expect such approval by the end of February.Hawaii : We h … More ave encountered delays in beginning enrollment at the Hawaii site due to the logistics of establishing the study infrastructure at this site distant from the Japanese and American primary investigators. However, the designation of Mary Flynn, M.D., the new Medical Director of the Blood Bank of Hawaii, as the person primarily responsible for the study has greatly facilitated these problems. Dr.Flynn has taken charge of the initial arrangements, including setting up of budgetary arrangements, and the designation of a skilled research technician who was recently laid off from the blood bank to perform the study enrollments. The study protocol is currently under review from the Human Subjects' Review Committee of the Blood Bank of Hawaii. As soon as this review is completed, we intend to begin enrollment of subjects. The updated total of HTLV-1 infected Japanese-American women eligible for the study in Hawaii is now 35. Nagasaki : Approval of the Human Right Committee of Nagasaki University has been obtained. Using ATL Prevention Program (APP) at Nagasaki, approximately 25 of 50 planned women have been already enrolled.b. Study Headquarters at UCSFProcedures for processing blood samples according to the red blood cell lysis protocol have been established and are in place both in Nagasaki and in San Francisco. It is planned that the other American sites will send their samples by overnight mail to the UCSF laboratory of Dr.Murphy for preservation of white blood cell pellets as well as plasma specimens. Additional preliminary studies on quantitative PCR on HTLV-1 specimens have been accomplished and show a correlation between HTLV-1 viral load and HTLV-1 antibody titer. Less